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LEGAL ACTS OF THE REPUBLIC OF LATVIA
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Text consolidated by Valsts valodas centrs (State Language Centre) with amending regulations of:

25 June 2013 [shall come into force on 29 June 2013];
27 August 2013 [shall come into force on 1 January 2014];
16 December 2014 [shall come into force from 19 December 2014];
26 January 2016 [shall come into force from 2 February 2016].

If a whole or part of a paragraph has been amended, the date of the amending regulation appears in square brackets at the end of the paragraph. If a whole paragraph or sub-paragraph has been deleted, the date of the deletion appears in square brackets beside the deleted paragraph or sub-paragraph.


Republic of Latvia

Cabinet
Regulation No. 800

Adopted 19 October 2011

Procedures for the Licensing of Pharmaceutical Activity

Issued pursuant to
Section 5, Clauses 1, 14, 19, and 26, Sections 37, 45, and 51
of the Pharmaceutical Law and Section 12,
Paragraph one of the law On Procedures for the Legal Trade of Narcotic and
Psychotropic Substances and Medicinal Products

[25 June 2013]

I. General Provisions

1. This Regulation prescribes:

1.1. procedures for issuing, suspending, re-registering and revoking special authorisations (licences) (hereinafter - the licence) for pharmaceutical activity:

1.1.1. a licence to manufacture or import medicinal products or investigational medicinal products from third countries (countries other than Member States of the European Union or European Free Trade Association countries that have signed the European Economic Area Agreement) (hereinafter - the licence to manufacture or import medicinal products), including from the countries where, in accordance with Section 51.2 of the Pharmaceutical Law, the manufacturing of veterinary medicinal products is indicated as a field of special activity and, in accordance with law On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, authorised manufacturing or importing activities involving substances included in lists II and III of narcotic substances, psychotropic substances and precursors controlled in Latvia (hereinafter - the controlled substances) and medicinal products which contain narcotic and psychotropic substances included in the abovementioned lists (hereinafter - the narcotic and psychotropic medicinal products) is indicated;

1.1.2. a licence to open (operate) a medicinal product wholesaler, including a licence in which, in accordance with Section 45.1 of the Pharmaceutical Law, distribution of veterinary medicinal products is indicated as a field of special activity (hereinafter - the licence to operate a medicinal product wholesaler) and, in accordance with the law On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, the permitted operations involving controlled substances and narcotic and psychotropic medicinal products are indicated;

1.1.3. a licence to open (operate) a general-type or open-type pharmacy (hereinafter - the licence to operate a general-type pharmacy) in which, in accordance with the law On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, the permitted operations involving controlled substances and narcotic and psychotropic medicinal products are indicated and which conforms to Section 36 of the Pharmaceutical Law:

1.1.3.1. for a pharmacist practice or assistant pharmacist practice;

1.1.3.2. for a pharmacist collective practice or assistant pharmacist collective practice;

1.1.3.3. for a capital company;

1.1.3.4. for a local government;

1.1.4. a licence to open (operate) a closed-type pharmacy or a pharmacy of a medical treatment institution (hereinafter - the licence to operate a closed-type pharmacy) in which, in accordance with the law On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, the permitted operations involving controlled substances and narcotic and psychotropic medicinal products are indicated;

1.1.5. a licence to manufacture active or controlled substances or pre-package spirits (excipient);

1.2. procedures for commencing operations (actually open a pharmacy in order for inhabitants to purchase medicinal products at the pharmacy) and operating general-type pharmacies, closed-type pharmacies (including operations of the pharmacy involving narcotic and psychotropic medicinal products and controlled substances) and medicinal product wholesalers (including operations of the wholesaler involving narcotic and psychotropic medicinal products and controlled substances), as well as procedures for the conformity assessment thereof;

1.3. procedures for commencing and conducting the manufacture of medicinal products (including manufacture of narcotic and psychotropic medicinal products and controlled substances), as well as procedures for the conformity assessment thereof;

1.4. procedures for evaluating conformity of distribution of medicinal products (except veterinary medicinal products) with the requirements of good distribution practice;

1.5. the amount of the State fee for issuing and re-registering the licence and the procedures, as well as the procedures for collecting the State fee;

1.6. foodstuffs to be distributed in pharmacies.

[25 June 2013]

2. This Regulation does not apply to issuing, suspending, re-registering and revoking a licence for a manufacturer or importer of veterinary medicinal products (that manufactures or imports only veterinary medicinal products), veterinary medicinal product wholesaler and veterinary pharmaceutical pharmacy to conduct veterinary pharmaceutical operations.

3. A decision to issue and re-register a licence shall be taken by the State Agency of Medicines (hereinafter - the Agency) following the conformity assessment of the manufacturing or importing of medicinal products or veterinary medicinal products, or investigational medicinal products, or of the manufacture of controlled substances, or following the conformity assessment of the medicinal product wholesaler (this shall not apply to active substances, except controlled substances), or, in accordance with Paragraph 35 of this Regulation, it is found that premises, equipment, devices, personnel and documentation of the pharmacy fulfil the requirements laid down in this Regulation, laws and regulations regarding operations of pharmacies, distribution of medicinal products and other laws and regulations governing pharmacy.

[25 June 2013]

4. The Agency shall take a decision to issue, suspend, renew, re-register and revoke the licences referred to in Sub-paragraphs 1.1.1, 1.1.2, 1.1.3, 1.1.4, and 1.1.5 of this Regulation, as well as on refusal to issue and re-register:

4.1. a licence to operate a general-type pharmacy:

4.1.1. for a pharmacist practice or assistant pharmacist practice;

4.1.2. for a pharmacist collective practice or assistant pharmacist collective practice;

4.1.3. for a capital company;

4.1.4. for a local government;

4.2. a licence to operate a closed-type pharmacy;

4.3. a licence to operate a medicinal product wholesaler;

4.4. a licence to manufacture or import medicinal products;

4.5. a licence to manufacture active substances or controlled substances or pre-package spirits (excipient) (for use in medical treatment and veterinary medicine).

[25 June 2013]

5. The licences referred to in Paragraph 4 of this Regulation are valid only at the address indicated in the relevant licences and on the premises of the site of pharmaceutical activity indicated in the relevant submissions for issuing (re-registering) the licence:

5.1. a licence to operate a medicinal product wholesaler shall include an authorisation to distribute veterinary medicinal products wholesale, if, in the Annex to that licence, the relevant authorised condition of a special activity referred to in Sub-paragraphs 72.6 and 72.7 of this Regulation is indicated as a field of special activity;

5.2. a licence to manufacture or import medicinal products shall include an authorisation to distribute manufactured medicinal products or veterinary medicinal products, or investigational medicinal products wholesale to which the particular licence applies;

5.3. a licence to manufacture active substances or controlled substances or to pre-package spirits shall include authorisation to distribute manufactured substances and pre-packaged spirits wholesale to which the particular licence applies;

5.4. a licence to manufacture or import medicinal products, a licence to manufacture active substances or controlled substances or to pre-package spirits shall be issued also in the following cases:

5.4.1. if the relevant medicinal products or veterinary medicinal products or investigational medicinal products, or active substance, or controlled substance or spirits are not intended for distribution in the territory of the Republic of Latvia or are intended only for export to third countries;

5.4.2. for performance of complete or partial manufacturing (pre-packaging, packaging and processing of finished product) process.

[25 June 2013]

6. The requirements for commencing manufacturing operations of medicinal products and - in the case referred to in Section 51.2 of the Pharmaceutical Law - of veterinary medicinal products or investigational medicinal products or active substances, or controlled substances, and procedures for conformity assessment are laid down in this Regulation and the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products.

[25 June 2013]

7. A licence to operate a general-type pharmacy and a licence to operate a medicinal product wholesaler give the right to distribute the following foodstuffs:

7.1. food supplements;

7.2. drinking water, mineral water, and spring water;

7.3. medicinal plants and medicinal herbal teas;

7.4. honey and apiculture products;

7.5. dietetic food, including:

7.5.1. artificial blends for infants and supplementary feeding blends for infants;

7.5.2. food for infants and small children;

7.5.3. dietary food with reduced energy value;

7.5.4. dietary food for people with health disorders;

7.6. chewing gums, breath fresheners, cough lozenges and lozenges with vitamins;

7.7. packaged herbal biological food products.

8. The licence shall be issued for an indefinite time period, taking into account the case referred to in Paragraph 14.1 of Transitional Provisions of the Pharmaceutical Law. If the information indicated in the licence and annexes thereto is changed, the licence shall be re-registered in accordance with this Regulation. A licence shall not be valid without the annexes referred to therein.

II. Requirements for the Submitter and the Documents to be Submitted

9. In order to obtain the licence referred to in Sub-paragraph 4.4 of this Regulation to manufacture or import medicinal products, a person, in whose name the licence is intended to be issued (hereinafter - the submitter), shall submit a submission (Annex 1) to the Agency for a conformity assessment and the issuing or re-registering of a licence to manufacture or import medicinal products. The requisite information and documents, including a description of the manufacturing plant (Annex 2), and, if medicinal products or veterinary medicinal products are manufactured only for export, the list of manufactured medicinal products or veterinary medicinal products intended for export (Annex 3), shall be appended to the submission.

10. A submitter shall ensure that the following requirements are conformed to and the following information is provided in the submission referred to in Paragraph 9 of this Regulation and the documents appended thereto:

10.1. a list of the medicinal products or veterinary medicinal products, or investigational medicinal products, which are intended to be manufactured or imported. For investigational medicinal products, the name, strength, form and type (Annexes 1 and 3) shall be indicated;

10.2. the relevant manufacturing or importing operations;

10.3. the site where the medicinal products or veterinary medicinal products, or investigational medicinal products, referred to in Sub-paragraph 10.1 of this Regulation will be manufactured, and the site where manufacturing and importing will be controlled and quality control will be carried out;

10.4. premises, technical equipment and devices, including control devices, suitable and proper for the manufacturing or importing of the medicinal products, veterinary medicinal products, or investigational medicinal products, referred to in Sub-paragraph 10.1 of this Regulation, which conform to the requirements referred to in the registration documentation for medicinal products or veterinary medicinal products, as well as the laws and regulations regarding manufacturing, control and storage of medicinal products or veterinary medicinal products;

10.5. suitable personnel at the disposal of the submitter and attestation that at least one official responsible for the manufacture and control of medicinal products or veterinary medicinal products, or investigational medicinal products, whose qualification and work experience conform to the requirements laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products, or investigational medicinal products (hereinafter - the qualified person), is permanently and continuously at the disposal of the submitter;

10.6. if narcotic and psychotropic medicinal products will be manufactured or imported - trade in narcotic and psychotropic medicinal products is ensured in accordance with the laws and regulations regarding trade in narcotic and psychotropic medicinal products, as well as the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy;

10.7. at least one official who is at the disposal of the submitter and who is responsible for the trade in narcotic and psychotropic medicinal products (if manufacturing or importing thereof is intended);

10.8. trade in spirits is ensured in accordance with the laws and regulations regarding the procedures for trading in spirits in the undertakings of pharmaceutical and veterinary pharmaceutical activity (if spirits are used in manufacturing or spirits are pre-packaged for use in medical treatment and veterinary medicine);

10.9. for investigational medicinal products - manufacturing processes for deactivisation of viruses or non-traditional agents (where appropriate).

11. In order to receive the licence referred to in Sub-paragraph 4.5 of this Regulation:

11.1. to manufacture controlled substances (also if the substances are manufactured for export only) or to pre-package spirits, a submitter shall submit a submission (Annex 1) to the Agency for conformity assessment and issuing of the licence to manufacture controlled substances (also if the substances are manufactured for export only). The required information and documents, including a description of the manufacturing plant (Annex 2) and a list of controlled substances (Annex 3), shall be appended to the submission;

11.2. for the manufacture of active substances (except controlled substances) (also if the substances are manufactured for export only), the submitter shall submit a submission to the Agency for the issuing of the licence. The following information shall be indicated in the submission:

11.2.1. the firm name of the licence applicant (manufacturer), registration number in the Commercial Register, legal address, and address of the site of pharmaceutical activity - manufacturing plant. A performer of economic activity who need not register in the Commercial Register (hereinafter - the performer of economic activity) shall indicate the given name and surname, personal identity number, address of the declared place of residence, and address of the manufacturing plant;

11.2.2. name of the active substance (International Non-proprietary Name (INN) or, if none, chemical name and substance registration number CAS);

11.2.3. content of the active substance;

11.2.4. status of the licence applicant:

11.2.4.1. manufactures a substance;

11.2.4.2. packages and labels the substance manufactured by another independent manufacturer;

11.2.5. information on whether the active substance is distributed in Latvia or manufactured for export only;

11.2.6. the given name and surname of the official responsible for the manufacturing of active substance;

11.2.7. if a foreign manufacturer is involved in the manufacturing of active substance - responsibility of the party involved in the manufacturing in respect of each stage of manufacture process and finished product, as well as the type and scope of control performed by each party.

[25 June 2013]

11.1 The licence referred to in Sub-paragraph 4.5 of this Regulation for the manufacturing of active substances is not necessary, if the submitter has been registered with the Agency in accordance with the procedures laid down in the laws and regulations regarding registration of importers, manufacturers and distributors of active substances. The submitter is entitled to request the Agency to issue the licence referred to in Sub-paragraph 4.5 of this Regulation for the manufacturing of active substances, if it is necessary for export of active substances.

[25 June 2013]

12. A submitter shall ensure that the following requirements are conformed to and the following information is provided in the submission referred to in Paragraph 11 of this Regulation and the documents appended thereto:

12.1. a list of controlled substances. If substances are manufactured for export only - a list of medicinal products or veterinary medicinal products manufactured only for export (Annex 3);

12.2. the relevant manufacturing or exporting operations;

12.3. the site where it is intended to manufacture active substances or controlled substances or pre-pack spirits and the site where it is intended to perform quality control, or the site which is at the disposal of the submitter for the manufacturing of active substances or controlled substances or pre-packaging of spirits;

12.4. if controlled substances are to be manufactured - trade in narcotic and psychotropic substances is ensured in accordance with the laws and regulations regarding trade in narcotic and psychotropic medicinal products, as well as the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy;

12.5. at least one official who is at the disposal of the submitter and is responsible for trade in controlled substances;

12.6. if spirits are used in the manufacturing or spirits are pre-packaged for use in medical treatment and veterinary medicine - trade in spirits is ensured in accordance with the laws and regulations regarding procedures for trade in spirits in undertakings of pharmaceutical and veterinary pharmaceutical activity.

[25 June 2013]

13. In order to receive the licence referred to in Sub-paragraph 4.3 of this Regulation, the submitter shall submit a submission to the Agency for conformity assessment and issuing or re-registering of the licence to operate a medicinal product wholesaler (Annex 4). The required information and documents shall be appended to the submission.

14. A submitter shall ensure that the following requirements are conformed to and the following information is provided in the submission referred to in Paragraph 13 of this Regulation and the documents appended thereto:

14.1. the site where medicinal products or veterinary medicinal products (if distribution of such is intended) or investigational medicinal products, or controlled substances will be stored and distributed, and the site where their control will be performed;

14.2. suitable and proper premises, technical equipment and devices (including control devices), in order to ensure due preservation and distribution of medicinal products or veterinary medicinal products (if it is intended to distribute such), or investigational medicinal products, or controlled substances, in accordance with the laws and regulations regarding distribution of medicinal products and veterinary medicinal products;

14.3. the submitter has at the disposal thereof personnel and responsible official (in a medicinal product wholesaler - for conformity with good distribution practice) conforming to the requirements laid down in the laws and regulations regarding distribution of medicinal products or veterinary medicinal products (hereinafter - the responsible person in the wholesaler);

14.4. resolution to perform duties that are laid down for the holder of the licence to operate the medicinal product wholesaler in the laws and regulations regarding distribution of medicinal products or veterinary medicinal products, including the principles and guidelines for good distribution practice of medicinal products (this shall not apply to veterinary medicinal products);

14.5. if narcotic and psychotropic medicinal products and controlled substances are distributed - trade in narcotic and psychotropic medicinal products and controlled substances is ensured in accordance with the laws and regulations regarding trade in narcotic and psychotropic substances and medicinal products, as well as the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy;

14.6. at least one official who is responsible for trade in narcotic and psychotropic medicinal products and controlled substances (if storage and distribution thereof are intended) is at the disposal of the submitter;

14.7. if spirits are distributed - trade in spirits is ensured in accordance with the laws and regulations regarding procedures for trade in spirits in undertakings of pharmaceutical and veterinary pharmaceutical operations.

15. In order to receive the licence referred to in Sub-paragraph 4.1 or 4.2 of this Regulation to operate a general-type pharmacy or closed-type pharmacy (hereinafter - the pharmacy), a submitter shall submit a submission to the Agency regarding issuing or re-registering of the licence to operate the pharmacy or regarding changes in the submitted information and documents (Annex 5). The required information and documents, including attestation regarding conformity of premises, equipment, personnel and documentation with this Regulation and the laws and regulations regarding operation of pharmacies, shall be appended to the submission.

16. If a general-type pharmacy or a branch of a pharmacy is opened anew or moved, prior to submitting the submission referred to in Paragraph 15 of this Regulation to the Agency an applicant for a licence shall submit a submission in which he or she shall indicate the pharmacy and branch of the pharmacy for which the site of pharmaceutical activity will be changed and the new address of the site of pharmaceutical activity, as well as indicate whether preparation of medicinal products and day-and-night work are intended. If a pharmacy is moved, the layout map of the territory referred to in the laws and regulations regarding criteria for location of pharmacies shall be appended in annex to the submission where the locations of the nearest pharmacies are indicated and on which the applicant has marked a circle (with a radius of 500 m) in the centre of which the pharmacy to be moved and to be newly opened is located.

17. The requirement referred to in Paragraph 16 of this Regulation regarding submitting of the submission to the Agency need not be applied, if the submission regarding opening of a pharmacy is submitted by a local government in accordance with the laws and regulations regarding criteria for location of pharmacies and branches of pharmacies.

18. The Agency shall perform the following with the submission referred to in Paragraph 16 of this Regulation:

18.1. register it on the day of receipt thereof in the sequence of receipt, granting a registration sequence number to each submission;

18.2. publish information on its website in accordance with Sub-paragraph 77.11 of this Regulation within two working days after receipt of the submission.

19. The Agency shall evaluate the submission referred to in Paragraph 16 of this Regulation (taking into account the registration sequence number) and within five working days take a decision on the location of the pharmacy or branch of the pharmacy, if there is conformity with the permissible number of pharmacies and the location of the pharmacy or branch of the pharmacy in accordance with the Pharmaceutical Law and the laws and regulations regarding criteria for location of pharmacies and branches of pharmacies, or take a decision to refuse the location of the pharmacy or branch of the pharmacy.

20. If a pharmacy or a branch of a pharmacy is opened anew or moved, the submission referred to in Paragraph 15 of this Regulation for the licence to operate a general-type pharmacy may be submitted to the Agency only by the person who has received the decision referred to in Paragraph 19 of this Regulation regarding the location of the pharmacy or branch of the pharmacy, or by a local government in accordance with the laws and regulations regarding criteria for location of pharmacies and branches of pharmacies.

21. The submission referred to in Paragraph 15 of this Regulation for the licence to operate a general-type pharmacy shall be submitted to the Agency within 60 days after taking of the decision referred to in Paragraph 19 of this Regulation regarding the location of pharmacies or branches of pharmacies.

22. The Agency shall take a decision to refuse the location of a pharmacy or a branch of a pharmacy, if:

22.1. the maximum permissible number of general-type pharmacies is exceeded (if a new pharmacy is opened) or the location of the pharmacy of branch of the pharmacy does not conform to the Pharmaceutical Law and the laws and regulations regarding criteria for location of pharmacies and branches of pharmacies;

22.2. the submission referred to in Paragraph 15 of this Regulation is registered in the Agency regarding issuing or re-registering of a licence (change of the site of pharmaceutical activity) regarding which the Agency has not taken a relevant decision, and the indicated location of the pharmacy or branch of the pharmacy does not conform to the Pharmaceutical Law and the laws and regulations regarding criteria for location of pharmacies and branches of pharmacies;

22.3. several submissions referred to in Paragraph 16 of this Regulation have been submitted regarding the same site regarding one of which the decision referred to in Paragraph 19 of this Regulation on the location of the pharmacy or branch of the pharmacy has been submitted.

23. The submission referred to in Paragraph 16 of this Regulation may be submitted to the Agency in printed form or in the form of an electronic document in person, sent by post or electronically. An electronic document, if it is recorded in a data carrier, may be submitted in person or sent by post. The decision referred to in Paragraph 19 of this Regulation shall be sent electronically or by post, or issued to the submitter in person by the Agency not later than on the next working day after taking thereof. If the Agency sends the decision by post, concurrently it shall also be sent by fax or to electronic mail address, if the submitter has indicated a fax number or electronic mail address in the submission.

24. The Agency shall publish the decision referred to in Paragraph 19 of this Regulation on the location of the pharmacy or branch of the pharmacy on its website within one working day in accordance with Sub-paragraph 77.12 of this Regulation.

25. If a person who has received the decision referred to in Paragraph 19 of this Regulation on the location of the pharmacy or branch of the pharmacy has not submitted to the Agency the submission referred to in Paragraph 15 of this Regulation within 60 days after taking of the abovementioned decision, the Agency shall examine the next submissions (according to the sequence of their registration) regarding which a decision to refuse the location of the pharmacy or branch of the pharmacy was taken by informing the submitters thereof.

26. In addition to the decisions referred to in Paragraph 61 of this Regulation on refusal to issue or re-register a licence the Agency shall refuse to issue or re-register the licence to operate a general-type pharmacy, if:

26.1. the decision referred to in Paragraph 19 of this Regulation to refuse the location of the pharmacy or branch of the pharmacy is taken;

26.2. the requirements referred to in Paragraphs 20 and 21 of this Regulation have not been met;

26.3. the procedures referred to in Paragraph 16 of this Regulation have not been conformed to (this shall not apply to taking of a decision on submissions already submitted to the Agency regarding issuing or re-registering of a licence in relation to change of the site of pharmaceutical activity or commencement of day-and-night work and preparation of medicinal products, if the relevant decision to issue or re-register the licence has not been taken yet).

27. The Agency shall ensure the issuing of the licence referred to in Paragraph 59 of this Regulation not later than within five working days after taking of the decision to issue or re-register the licence.

28. If a submission regarding the necessity for a general-type pharmacy is submitted by a local government in accordance with the laws and regulations regarding criteria for location of pharmacies and branches of pharmacies, the Agency shall take a decision to reject the submission of the local government in the following cases (this shall not apply to a submission regarding necessity to open a general-type pharmacy which is open day-and-night):

28.1. the address of the desirable location of the pharmacy is not indicated in the submission of the local government;

28.2. a functioning general-type pharmacy is closer than three kilometres from the desirable location indicated by the local government;

28.3. a submission regarding re-registering of the licence in relation to moving of a pharmacy existing in the particular populated area closer than three kilometres from the location of the pharmacy indicated by the local government has been registered in the Agency.

29. If a submission regarding the necessity for a general-type pharmacy, which is open day-and-night, is submitted by a local government in accordance with the laws and regulations regarding criteria for location of pharmacies and branches of pharmacies, the Agency shall take a decision to reject the submission of the local government regarding a pharmacy, which is open day-and-night, in the following cases:

29.1. in the case referred to in Sub-paragraph 28.1 of this Regulation;

29.2. there is a functioning day-and-night general-type pharmacy in the particular populated area;

29.3. a submission regarding re-registering of the licence in relation to commencement of day-and-night work by the pharmacy existing in the particular populated area or moving of a pharmacy and commencement of day-and-night work has been submitted to the Agency;

29.4. the location of the pharmacy indicated in the submission of the local government is closer than 500 metres from an existing licensed pharmacy where medicinal products are prepared.

30. The submitter shall ensure that the following requirements are conformed to and that the following information is provided in the submission referred to in Paragraph 15 of this Regulation and the information and documents appended thereto (including in the attestation regarding premises, equipment, personnel and documentation):

30.1. suitable and proper premises, technical equipment and devices (including control devices), as well as documentation, are at the disposal of the submitter in order to ensure distribution of medicinal products or veterinary medicinal products (if it is intended to distribute such) in accordance with the laws and regulations regarding opening and operation of pharmacies and distribution of medicinal products and veterinary medicinal products. The abovementioned premises shall conform to the plan of premises referred to in Sub-paragraph 16.3 of Annex 5 to this Regulation, and it shall not be permitted to carry out operations of another merchant or performer of economic activity therein;

30.2. personnel and a manager of the pharmacy whose education and professional experience conforms to the requirements laid down in the Pharmaceutical Law are at the disposal of the submitter;

30.3. if narcotic and psychotropic medicinal products and controlled substances are distributed - trade in narcotic and psychotropic medicinal products and controlled substances is ensured in accordance with the laws and regulations regarding trade in narcotic and psychotropic substances and medicinal products, as well as the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy;

30.4. at least one official who is responsible for trade in narcotic and psychotropic medicinal products and controlled substances (if is intended to distribute such) is at the disposal of the submitter.

III. Conformity Assessment for the Issuing or Re-registering of a Licence and Procedures for Conformity Assessment of Good Distribution Practices of Medicinal Products

31. The Agency shall register the submissions referred to in Paragraphs 9, 11, 13, and 15 of this Regulation and the information and documents appended thereto (hereinafter - the licence file) on the day of receipt thereof. Within five working days after receipt of the documents they shall be evaluated by carrying out initial expert-examination in the sequence of the document registration, and an invoice regarding expert-examination and conformity assessment of documents according to the price list of paid services of the Agency shall be issued (or sent by post) to the submitter.

[26 January 2016]

32. During initial expert-examination the Agency shall evaluate whether the data and documents referred to in Annexes 1, 2, 3, 4, and 5 to this Regulation are included in the submission and whether all data and documents indicated in the relevant submission are submitted.

33. If during the initial expert-examination it is determined that the data and documents referred to in Annexes 1, 2, 3, 4, and 5 to this Regulation are not included in the submission or all data and documents indicated in the relevant submission are not submitted, the Agency shall immediately notify the submitter in writing after completion of the initial expert-examination and indicate the information to be submitted additionally, where necessary, by communicating with the submitter also by phone.

34. In order to assess the conformity of manufacturing or importing of medicinal products or veterinary medicinal products, or investigational medicinal products, or manufacture of controlled substances, or a medicinal product wholesaler with the intended work amount and nature, after initial expert-examination and becoming familiar with the licence file the Agency shall evaluate the documents of the file and carry out a conformity assessment inspection at the site indicated in Sub-paragraphs 10.3, 12.3, and 14.1 of this Regulation. It shall be ascertained during the inspection whether:

34.1. the premises, equipment, devices, personnel and documentation of a medicinal product wholesaler conform to the laws and regulations regarding distribution of medicinal products, as well as to the conditions of special activity referred to in the submission. The inspection shall be carried out within 30 days after receipt of the submission;

34.2. the premises, equipment, devices, personnel and documentation required for the manufacturing or importing of medicinal products or veterinary medicinal products, or investigational medicinal products, or manufacturing of controlled substances conform to the requirements of good manufacturing practice laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products, as well as to the types of condition of a special activity referred to in the submission. The inspection shall be carried out within 60 days after receipt of the submission.

35. In order to assess the conformity of a pharmacy with work amount and nature indicated in the submission, after initial expert-examination and becoming familiar with the licence file the Agency shall evaluate the file documents and ascertain that the premises, equipment, devices, personnel and documentation of the pharmacy conform to the requirements laid down in the laws and regulations regarding operation of pharmacies and distribution of medicinal products, in the laws and regulations regarding distribution of veterinary medicinal products, and other laws and regulations governing pharmacy, as well as to the conditions of a special activity referred to in the submission.

[26 January 2016]

36. After the conformity assessment referred to in Paragraph 35 of this Regulation an official of the Agency shall draw up an opinion and append it to the relevant licence file.

37. After inspection of the conformity assessment referred to in Sub-paragraph 34.1 of this Regulation an official of the Agency shall draw up a report. The following shall be indicated in the report:

37.1. the firm name, legal address thereof or performer of economic activity and address of his or her declared place of residence, name of the object of pharmaceutical activity, address of the site of pharmaceutical activity and date of inspection;

37.2. the number of the relevant licence and indication "Licence issued for an indefinite time period". If inspection of conformity assessment is performed for re-registration of the licence and the licence has a time frame, the term of validity of the licence shall be indicated;

37.3. activities performed and facts detected during an inspection;

37.4. the conclusions on conformity of the established facts with the information indicated in the submission and submitted documents;

37.5. information on conformity of the established facts with the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy. If non-conformity with the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy or non-conformity with the requirements laid down in the laws and regulations governing trade in narcotic and psychotropic substances is determined, the title, Section or Paragraph of the particular law or regulation shall be indicated;

37.6. the time frame for rectification of infringements and deficiencies established, as well as the requirement to submit a plan for rectification of deficiencies;

37.7. if conformity is assessed in relation to a licence re-registration:

37.7.1. the date when the previous inspection or conformity assessment of good distribution practices of medicinal products was performed;

37.7.2. information on whether the infringements and deficiencies referred to in the previous control report have been established repeatedly;

37.7.3. information on imposed administrative punishments for infringements of the laws and regulations of pharmaceutical or veterinary pharmaceutical activity or infringements of the laws and regulations of trade in narcotic and psychotropic substances and medicinal products after the previous inspection, indicating also officials who have been punished and information on payment of fine;

37.8. proposal regarding issuing, suspending, re-registering or revoking of a relevant licence;

37.9. the given names, surnames, positions and signatures of the officials who performed the inspection, as well as the date of drawing up of the report.

38. The officials of the Agency shall carry out the inspection of the conformity assessment referred to in Sub-paragraph 34.2 of this Regulation by taking into account the norms laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products. After inspection a control report shall be drawn up in conformity with the sample laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products.

39. The report referred to in Paragraph 37 of this Regulation shall be drawn up in three copies. One copy shall be issued to the submitter, another copy shall be kept in the record-keeping of the Agency, and the third copy shall be appended to the licence file.

40. If during inspection of the manufacturer or importer of medicinal products or veterinary medicinal products, or investigational medicinal products, or manufacturer of controlled substances critical or significant deficiencies are determined and indicated in the report referred to in Paragraph 38 of this Regulation, the submitter shall submit a plan for rectification of deficiencies to the Agency within 10 days after receipt of the report of inspection of conformity assessment. If more than five days are necessary for rectification of deficiencies, a submission regarding extending the term for examination of the file shall be submitted concurrently with the plan for rectification of deficiencies. The submitter shall inform the Agency in writing regarding rectification of deficiencies.

41. A licence holder shall submit a submission to the Agency (free text) with a request to supplement the licence file with new information and documents within 10 working days, if there are changes:

41.1. in the submission referred to in Annex 1, 3, 4 or 5 to this Regulation and information provided in the documents appended thereto in the following cases:

41.1.1. if the manager of a pharmacy or the responsible official in a wholesaler is replaced temporarily from 30 to 120 days by another official;

41.1.2. the official responsible for the performance of conditions of a special activity is changed (if such person is not indicated in Annex to the licence);

41.1.3. the list of manufactured or imported medicinal products or veterinary medicinal products or manufactured controlled substances (Annex 3) has been supplemented or changed (this condition shall not apply to supplementation of the list with new pharmaceutical form or type);

41.1.4. working hours of the medicinal wholesaler or pharmacy has been changed (except cases when a pharmacy will not work anymore or will work day-and-night henceforth);

41.1.5. information on pharmaceutical activity (Annex 5) has been changed;

41.2. in the information referred to in Sub-paragraph 11.2 of this Regulation in the following cases:

41.2.1. the responsible official is replaced by another official for three months or more;

41.2.2. the list of active substances is supplemented or changed.

[25 June 2013]

42. If there are changes in the licence or information indicated in Annexes thereof other than referred to in Paragraph 41 of this Regulation (especially - if the qualified person, responsible official or manager of the pharmacy is changed, including if the manager of the pharmacy or responsible official is temporarily replaced by another official for more than 120 days), the licence holder shall submit a submission to the Agency regarding re-registering of the licence within five working days after introduction of changes. The changes shall be indicated in the submission in conformity with the form laid down in Annex 1, 2, 3, 4 or 5 to this Regulation or Sub-paragraph 11.2 of this Regulation by including only the information on the changes. A submission for re-registering of the licence shall be submitted also when another person is hired instead of the manager of the pharmacy or responsible official of the medicinal product wholesaler indicated in the licence, or the manager of the pharmacy or responsible official of the medicinal product wholesaler indicated in the licence is dismissed, or the pharmacy wishes to supplement the licence with the condition of a special activity referred to in Sub-paragraphs 70.1, 70.2, 70.3, 70.4, 70.6, 70.7, 70.8, and 70.9 of this Regulation.

[26 January 2016]

43. The licence referred to in Sub-paragraphs 4.3, 4.4, and 4.5 of this Regulation (this shall apply to controlled substances and pre-packaging of spirits) shall be re-registered without carrying out the inspection of the conformity assessment referred to in Paragraph 34 of this Regulation, if the licence holder submits a submission to the Agency to which information and documents are appended in accordance with Annex 1, 3 or 4 to this Regulation or in accordance with Sub-paragraph 11.2 of this Regulation and where it is indicated that:

43.1. the information referred to in the licence or Annexes thereto has been changed (except the cases referred to in Sub-paragraphs 44.1, 44.2, 44.3, 44.4, and 44.5 of this Regulation);

43.2. henceforth some of the medicinal products or veterinary medicinal products, or investigational medicinal products, or pharmaceutical forms, or controlled substances, or active substances referred to in the licence file will not be manufactured or pre-packaging of spirits will not be performed;

43.3. henceforth some of the medicinal products or veterinary medicinal products, or investigational medicinal products, or controlled substances referred to in the licence file will not be imported from the third countries;

43.4. any of the conditions of a special activity referred to in Paragraphs 72 and 73 of this Regulation will not be implemented;

43.5. the qualified person, responsible official in a wholesaler, official responsible for the manufacturing of active substances or controlled substances or official responsible for the performance of conditions of special activity, who is indicated in Annex to the licence to manufacture or import medicinal products has been changed;

43.6. address of the manufacturing plant of active substance has been changed.

[25 June 2013]

44. The licence referred to in Sub-paragraphs 4.3, 4.4, and 4.5 of this Regulation (this shall not apply to active substances, except controlled substances) shall be re-registered by carrying out the inspection of the conformity assessment laid down in Paragraph 34 of this Regulation in the following cases:

44.1. before manufacturing or importing of new medicinal products or veterinary medicinal products, or new type of investigational medicinal products, or new pharmaceutical form or commencement of manufacturing of a new controlled substance;

44.2. if a laboratory with which a contract regarding quality control has been entered into, or a manufacturer with which a contract regarding performance of manufacturing operations has been entered into has been changed;

44.3. if it is intended to supplement a pharmaceutical activity with any of the conditions of a special activity referred to in Paragraph 72 or 73 of this Regulation;

44.4. before manufacturing of medicinal products or veterinary medicinal products, or investigational medicinal products, or controlled substances, or commencement of operations of a medicinal product wholesaler in a new site;

44.5. in other cases related to significant changes in premises, devices, equipment, personnel and documentation of manufacturing, quality control or distribution;

44.6. upon a substantiated request of the licence holder;

44.7. if the operation of the licence to manufacture or import medicinal products or to manufacture controlled substances has been suspended on the basis of a written proposal by a competent State authority regarding infringements established in the manufacturing or importing, control or distribution of medicinal products or veterinary medicinal products, or investigational medicinal products, or manufacturing, control or distribution of controlled substances.

[25 June 2013]

45. The Agency shall carry out inspection of the conformity assessment of the licensed person (which is dealing with manufacturing or importing of medicinal products) within three up to six months after commencement of operations of the licensed person or after re-registering of the licence in the case referred to in Paragraph 44 of this Regulation. The conformity inspection shall be carried out in order to ascertain whether manufacturing of medicinal products or veterinary medicinal products (if it is intended to manufacture such) conforms to the conditions of good manufacturing practice referred to in Sub-paragraph 34.2 of this Regulation. The Agency shall draw up a control report of good manufacturing practice regarding conformity assessment of good manufacturing practice of medicinal products and veterinary medicinal products in accordance with the requirements of the laws and regulations governing manufacturing of medicinal products and veterinary medicinal products.

46. Within three up to six months after commencement of operation of the licensed medicinal product wholesaler or re-registering of the licence in the case referred to in Sub-paragraphs 44.3, 44.4, and 44.5 of this Regulation the officials of the Agency shall carry out inspection of the conformity assessment of the licensed person in order to ascertain that the procedures for distributing medicinal products (except veterinary medicinal products) conform to the principles of good distribution practices of medicinal products laid down in the laws and regulations regarding distribution of medicinal products. The Agency shall draw up a report on conformity assessment of good distribution practices of medicinal products in accordance with Paragraph 37 of this Regulation.

47. Within three up to six months after commencement of operation of the licensed pharmacy or re-registering of the licence due to change of premises (move) of the pharmacy, or commencement of performance of the conditions of the special activity referred to in Sub-paragraphs 70.3, 70.4, 70.6, 71.3, and 71.4 of this Regulation the officials of the Health Inspectorate (hereinafter - the Inspectorate) shall carry out control in the pharmacy in order to ascertain that the operation of the pharmacy conforms to the requirements laid down in the laws and regulations governing pharmacy and trade in narcotic and psychotropic substances and medicinal products. A control statement shall be drawn up regarding such control.

48. In order to ensure regular supervision of pharmacy and medicinal products wholesaler after issuing of the licence to operate a medicinal product wholesaler, officials of the Inspectorate and Agency shall assess, in conformity with the competence thereof not less than once in three years, the conformity of the pharmacy and medicinal product wholesaler with the relevant laws and regulations regarding operations of pharmacies and distribution of medicinal products, including conformity with the principles of good distribution practices and guidelines for the medicinal product wholesaler.

49. After inspection referred to in Paragraph 48 of this Regulation the report referred to in Paragraph 37 of this Regulation shall be drawn up. If it is indicated in the report that:

49.1. the medicinal product wholesaler conforms to the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy and trade in narcotic and psychotropic substances and medicinal products, a report shall be appended to the licence file;

49.2. infringements of the laws and regulations governing pharmacy or veterinary pharmacy, as well as the laws and regulations governing trade in narcotic and psychotropic substances and medicinal products and deficiencies have been established in the medicinal product wholesaler, the officials of the Agency shall determine the time period for rectification thereof, or, where appropriate, request to submit a plan for rectification of deficiencies. The report shall be appended to the licence file;

49.3. infringements of the laws and regulations governing pharmacy, as well as of the laws and regulations governing trade in narcotic and psychotropic substances and medicinal products referred to in the previous control statement and essential deficiencies have been established repeatedly in the medical product wholesaler, the officials of the Agency shall propose to suspend the operation of the licence or to revoke the licence. The report shall be appended to the licence file.

50. If a licence issued in printed form is lost or irreparably damaged, the licence holder shall submit a submission to the Agency. The reason for issuing of a licence duplicate, as well as a receipt regarding payment for issuing of the duplicate according to the price list of paid services of the Agency shall be indicated in the submission.

[26 January 2016]

IV. Decisions of the Agency

51. The Agency shall take the following decisions:

51.1. to issue or re-register a licence;

51.2. to suspend the operation of a licence or to suspend the condition of a special activity indicated in the licence;

51.3. to renew the operation of a licence or to renew the condition of a special activity indicated in the licence;

51.4. to issue or re-register a licence by defining a requirement for the submitter to perform certain conditions that the licence holder shall ensure the conformity of premises or equipment, or devices, or personnel, with the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy, as well as the laws and regulations regarding trade in narcotic and psychotropic substances within the time period stipulated by the Agency;

51.5. to extend the time period for examination of the file, if additional information (the information provided in the submission or documents appended thereto is insufficient or there are doubts regarding its veracity), additional inspection is necessary or a submission regarding supplementing of the licence file with new information or documents is received;

51.6. to revoke a licence or to revoke conditions of a special activity indicated in the licence;

51.7. to suspend the operation of a licence to manufacture or import medicinal products or to manufacture controlled substances or active substances, or to pre-package spirits in respect of manufacturing (for spirits - pre-packaging) or importing - accordingly - of particular medicinal products or veterinary medicinal products, or investigational medicinal products, or controlled substances, or active substances (that referred to in the licence file), on the basis of the report of a competent State authority on the infringements of pharmaceutical or veterinary pharmaceutical operations referred to in Paragraph 63 of this Regulation;

51.8. to renew the operation of a licence to manufacture or import medicinal products or to manufacture controlled substances or active substances, or to pre-package spirits in respect of manufacturing or importing of particular medicinal products or veterinary medicinal products, or investigational medicinal products, or controlled substances, or manufacturing of active substances, or pre-packaging of spirits, if operation of the licence has been suspended on the basis of the report of the competent authority;

51.9. to refuse to issue a licence in the cases referred to in Paragraph 61 of this Regulation.

[25 June 2013]

52. The Agency shall take the decision referred to in Sub-paragraph 51.2 of this Regulation in respect of a particular licensed pharmacy, if suspending of the licence is justified by the initiative of the licensed person, not more than twice per time period which does not exceed six months each time.

53. If the Agency has taken a decision to extend the time period for examination of the file, the submitter shall be notified thereof by phone on the day of taking of the decision and the abovementioned decision shall be sent by fax and electronic mail (if an electronic mail address is indicated in the submission) to the submitter within 10 days. If additional inspection is necessary, the officials of the Agency shall ensure the performance thereof and a control report shall be drawn up thereon in accordance with Paragraph 37 of this Regulation.

54. If the requested additional information is not received within the laid down time period, the Agency shall examine the file and take a decision.

55. On the day of taking of the decision, if urgency is justified by the fact that any delay directly endangers State security, public order, environment, human life, health or property, the following decisions of the Agency shall enter into effect:

55.1. a decision to revoke the licence;

55.2. a decision to suspend the operation of the licence;

55.3. a decision to suspend individual conditions of special activity;

55.4. a decision to suspend a licence to manufacture or import medicinal products or to manufacture controlled substances or active substances, or to pre-package spirits in respect of manufacturing or importing - accordingly - of particular medicinal products or veterinary medicinal products, or investigational medicinal products, or controlled substances, or active substances (referred to in the licence file) or pre-packaging of spirits.

[25 June 2013]

56. The decision of the Agency to issue or re-register a licence shall enter into effect on the tenth day after taking thereof. The Agency may determine a shorter time period when a decision to suspend the operation of the licence, to renew the operation of the licence, to renew individual conditions of a special activity or to renew the operation of the licence in respect of manufacturing or importing of particular medicinal products or veterinary medicinal products, or investigational medicinal products, or manufacturing of controlled substances or active substances, or pre-packaging of spirits.

[25 June 2013]

57. The Agency shall notify the decision referred to in Paragraph 55 of this Regulation to the licence holder by phone on the day of taking of the decision and send a decision by fax and electronic mail (if the electronic mail address is indicated in the submission).

58. After receipt of the submission, information and documents referred to in Paragraphs 9, 11, 13, and 15 of this Regulation, the Agency shall take a decision to issue a licence to manufacture or import medicinal products or to manufacture controlled substances or active substances, or to pre-package spirits, or to operate a medicinal product wholesaler, or to operate a pharmacy, to extend the time period for examination of the file or to refuse to issue the licence within the time period laid down in the Administrative Procedure Law.

[25 June 2013]

59. A licence or re-registered licence shall be issued or sent by post when the submitter or licence holder has performed payment for expert-examination of the documents and inspection of conformity assessment according to the price list of paid services of the Agency, as well as has paid the State fee for issuing of the licence.

[26 January 2016]

60. If the Agency takes the decision referred to in Sub-paragraph 51.6 of this Regulation to revoke the licence on the basis of the report of officials of control institutions, it shall determine a time period (not more than two months) from which the licence is revoked and indicate it in the decision taken. The Agency shall notify the licence holder and Inspectorate regarding such decision within three days.

61. The Agency shall take a decision to refuse to issue or re-register a licence in the following cases:

61.1. if on the basis of the provided information, documents and report (this shall not apply to active substances) it is determined that the submitter or licence holder cannot ensure fulfilment of the requirements laid down in the laws and regulations governing trade in pharmaceutical or veterinary pharmaceutical, or narcotic and psychotropic medicinal products, controlled substances, spirits and active substances, or any of the documents, on the basis of which the licence was issued, is not in effect;

61.2. non-conformity with the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy and trade in narcotic and psychotropic medicinal products and controlled substances has been established;

61.3. if the documents required for obtaining of the licence have not been received, they are incomplete, the information provided therein is incomplete and not true or documents are falsified;

61.4. the pharmaceutical activity or activity involving narcotic and psychotropic medicinal products, controlled substances, active substances, or pre-packaging of spirits is performed without a proper licence;

61.5. insolvency of the submitter has been determined by a court judgment in insolvency proceedings (in case of issuing a new licence);

61.6. if a report of the competent authority has been received that the conditions referred to in Sub-paragraph 81.11 of this Regulation are not fulfilled, and the competent authority has provided a warning in writing, determining a time period for rectification of infringements, however, the infringements have not been rectified within the determined time period;

61.7. if a report of the competent authority that the accessibility of the environment is not ensured for a general-type pharmacy to be newly opened or, if the pharmacy is moved, accessibility of the environment is not ensured in the new site of operation in accordance with Sub-paragraph 81.12 of this Regulation;

61.8. if reconstruction or renovation of a building must be carried out for ensuring the accessibility of the environment but the relevant requirements are technically impossible to be conformed to or due to conforming to them the building would lose its cultural and historical value (this shall apply to pharmacies to be newly opened or movement of a pharmacy).

[25 June 2013]

62. The Agency shall take the decision referred to in Sub-paragraph 51.2 of this Regulation to suspend a licence to operate a medicinal product wholesaler or to operate a pharmacy, or to suspend the condition of a special activity indicated in the licence in the following cases:

62.1. the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy, trade in narcotic and psychotropic substances and medicinal products have been violated and the Agency has received a justified proposal from competent State authorities in writing regarding suspension of the licence;

62.2. medicinal products, investigational medicinal products, veterinary medicinal products, psychotropic and narcotic medicinal products and controlled substances are stored or distributed in premises other than those indicated in the licence file;

62.3. the pharmacy does not ensure the conditions of a special activity laid down in Annex to the licence referred to in Paragraph 70 of this Regulation, which are laid down in the laws and regulation regarding operations of pharmacies;

62.4. during a year the Inspectorate has determined repeatedly that the working hours of a pharmacy or medicinal product wholesaler indicated in the submission and documents appended thereto or working hours of a manager of the pharmacy or responsible official (in a wholesaler) are not observed;

62.5. data on changes in the submitted information and documentation are not provided in accordance with Paragraphs 41 and 42 of this Regulation;

62.6. the information that is laid down in the laws and regulations governing pharmacy or veterinary pharmacy is not provided to the Agency, Inspectorate or Food and Veterinary Service;

62.7. the established infringements or deficiencies are not rectified within the time period laid down by the competent authorities or - in the case referred to in Sub-paragraph 51.4 of this Regulation - the decision or the Agency is not fulfilled or deficiencies rectified within the time period laid down;

62.8. the personnel that is at the disposal of the licence holder fails to conform to the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy, trade in narcotic and psychotropic substances and medicinal products;

62.9. the licence holder fails to ensure the possibility for officials of competent authority to carry out control of distribution of medicinal products, veterinary medicinal products, investigational medicinal products and controlled substances at any time or prevents performance thereof;

62.10. the licence holder or responsible officials have not paid the fine imposed for infringements of the laws and regulations governing pharmacy or veterinary pharmacy, trade in narcotic and psychotropic substances and medicinal products;

62.11. insolvency of the licence holder is determined in insolvency proceedings by a court judgement and bankruptcy proceedings have been commenced;

62.12. the licence holder has submitted a submission to the Agency to suspend the operation of the licence or the condition of a special activity indicated in the licence;

62.13. the holder of the licence for operation of the pharmacy has not submitted information and documents to the Agency in accordance with Paragraphs 41 and 42 of this Regulation;

62.14. the pharmacy has not ensured the accessibility of the environment in accordance with Sub-paragraph 81.12 of this Regulation and the Inspectorate has expressed a warning in writing, determining a time period for rectification of infringements not shorter than six months (if reconstruction is necessary for rectification of infringements), but the infringements have not been rectified or alternative technical solutions have not been introduced within the time period laid down by the Inspectorate - suspend the licence for a general-type pharmacy for six months. The abovementioned norm shall not be applied if reconstruction or renovation of a building must be carried out for ensuring of the accessibility of the environment in the pharmacy, but the relevant requirements are technically impossible to be conformed to or due to conforming to them the building would lose its cultural and historical value, as well as if the pharmacy is located in a municipality, municipality town or rural territory of the municipality where the number of inhabitants does not exceed 4000, and the accessibility of the environment is ensured by alternative technical solutions;

62.15. in the case referred to in Sub-paragraph 61.6. of this Regulation.

63. The Agency shall take the decision referred to in Sub-paragraph 51.2 of this Regulation to suspend the operation of the licence to manufacture or import medicinal products or to manufacture controlled substances, or to manufacture active substances, or to pre-package spirits, or the decision to suspend the condition of a special activity indicated in the licence, or the decision referred to in Sub-paragraph 51.7 of this Regulation to suspend the licence temporarily until rectification of deficiencies in respect of manufacturing or importing of specific medicinal products or veterinary medicinal products, or investigational medicinal products, or manufacturing of controlled substances or active substances referred to in the licence, or pre-packaging or spirits in cases when the licence holder:

63.1. within the specified time period has not ensured the fulfilment of the requirements of the licence referred to in Sub-paragraph 51.4 of this Regulation issued under a condition;

63.2. involves in the manufacturing personnel that is not trained in accordance with the laws and regulations regarding manufacturing and control of medicinal products and veterinary medicinal products;

63.3. in distribution (sale) fails to comply with the requirements laid down in the laws and regulations regarding distribution of medicinal products or veterinary medicinal products;

63.4. has not provided the data regarding changes in the submitted information and documentation in accordance with Sub-paragraph 41.1.2 and Paragraph 42 of this Regulation;

63.5. does not ensure a possibility for officials of the competent authority to enter the premises of the manufacturer at any time in order to carry out control of manufacturing of medicinal products or veterinary medicinal products, or investigational medicinal products, or controlled substances, or active substances or pre-packaging of spirits or hinders the performance thereof;

63.6. has not ensured the qualified person with a possibility to perform control and other duties, which have been laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products, or investigational medicinal products, and bringing in and bringing out of medicinal products;

63.7. fails to comply with the principles and guidelines of good manufacturing practice laid down in the laws and regulations regarding manufacturing and control of medicinal products (investigational medicinal products) and veterinary medicinal products or active substances and therefore the manufactured product may cause risk to human health;

63.8. information on conformity of manufacture of active substances, which are used as raw materials for the manufacture of medicinal products (investigational medicinal products) and veterinary medicinal products, with the requirements of good manufacturing practice of active substances is not at the disposal of the manufacturer;

63.9. the qualified person has not fulfilled his or her duties that are laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products and bringing in and bringing out of medicinal products;

63.10. during inspection cannot provide an attestation to officials of the competent authority regarding control carried out in intermediate stages of the manufacturing process of finished medicinal products or veterinary medicinal products, or investigational medicinal products, their ingredients or active substances in accordance with the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products;

63.11. allowed significant infringements and deficiencies in the manufacture of medicinal products (except veterinary medicinal products) or investigational medicinal products, or active substances, due to which the product may cause risk to human health and for rectification of which more than six months are required.

[25 June 2013]

64. In the decisions referred to in Sub-paragraphs 51.2 and 51.7 of this Regulation the Agency shall determine a time period for suspending the operation of the licence or suspending the condition of a special activity indicated in the licence, or suspending the operation of the licence in respect of activities of manufacturing or importing of specific medicinal products or veterinary medicinal products, or investigational medicinal products, or manufacturing of controlled substances or active substances, or pre-packaging of spirits. The abovementioned time period may not be longer than six months or until the end of the term of validity of the licence. In exceptional case, on the basis of a justified submission by the licence holder, the Agency may extend the time period for suspending the licence for not more than three months.

[25 June 2013]

65. If it is determined in the decision referred to in Paragraph 51 of this Regulation that the operation of the licence is suspended until rectification of the deficiencies or infringements established (if additional conformity assessment is not necessary), after receipt of information on rectification of deficiencies the Agency shall take a decision to renew operation of the licence.

66. If the operation of the licence is suspended in order to rectify infringements of the laws and regulations governing pharmacy or veterinary pharmacy established during an inspection carried out by the Inspectorate, the Agency or the Food and Veterinary Service and indicated in the report, or deficiencies and after rectification thereof additional conformity assessment (inspection) is necessary, the operation of the licence shall be renewed after receipt of the submission of the licence holder regarding renewal of the operation of the licence and control statement of the Inspectorate or the Food and Veterinary Service or drawing up of the report of the Agency.

67. Information on suspending the operation of the licence and on renewal of the operation of the licence shall be posted on the website of the Agency in accordance with Paragraph 77 of this Regulation.

[25 June 2013]

68. The Agency shall take a decision to revoke a licence or to revoke the condition of a special activity indicated in the licence in the following cases:

68.1. the merchant and the performer of economic activity manufactures or imports medicinal products or veterinary medicinal products, or investigational medicinal products or pharmaceutical forms, or controlled substances, or active substances not indicated in the licence file, or pre-packages spirits that is not indicated in the licence file;

68.2. activities of manufacture of medicinal products or veterinary medicinal products, or investigational medicinal products, or controlled substances, or active substances, or pre-packaging of spirits are carried out in the premises other than those referred to in the submission and description of the manufacturing plant (Annex 2);

68.3. significant infringements of the laws and regulations governing pharmacy or veterinary pharmacy related to risk to human health have been established repeatedly during a year;

68.4. the licence holder purchases medicinal products or veterinary medicinal products, or controlled substances from a person who in accordance with the laws and regulations governing pharmacy or veterinary pharmacy is not allowed to distribute medicinal products, veterinary medicinal products, or controlled substances;

68.5. the licence holder distributes medicinal products or veterinary medicinal products, or controlled substances without the permits laid down in the laws and regulations regarding bringing in and bringing out of medicinal products, distribution of medicinal products or veterinary medicinal products, trade in narcotic and psychotropic controlled substances and medicinal products;

68.6. the operation of the licence is suspended and the deficiencies which were the basis for suspending the operation of the licence have not been rectified within the time period laid down by the Agency;

68.7. the time period for suspending the operation of the licence referred to in Paragraph 64 of this Regulation has expired and the licence holder has not submitted a submission regarding renewal of the operation of the licence or re-registration thereof or has not rectified the established deficiencies or infringements within six months;

68.8. the Agency has received a written proposal of the competent State authorities to revoke the licence due to established infringements of the laws and regulations governing pharmacy or veterinary pharmacy, as well as trade in narcotic and psychotropic substances and medicinal products, and deficiencies;

68.9. it is established that the submitter has submitted false information that is essential in taking of a decision to issue a licence or, the submitter uses falsified documents when carrying out pharmaceutical or veterinary pharmaceutical activity;

68.10. it is established that the licence holder manufactures, imports or distributes falsified medicinal products or veterinary medicinal products, or investigational medicinal products, or controlled substances, or active substances;

68.11. the holder of the licence for the operation of the pharmacy after change of the site of pharmaceutical activity does not ensure the conditions of a special activity laid down in the licence;

68.12. the Agency has received a written submission of the licence holder regarding revoking of the licence due to termination of pharmaceutical or veterinary pharmaceutical activity;

68.13. the time period for commencing operations of a medicinal product wholesaler referred to in Sub-paragraph 81.8 of this Regulation has expired and the licence holder has not actually commenced the licensed operations, which is certified by the fact that the merchant has not submitted a submission regarding commencing the operations to the Agency;

68.14. the licence holder who has received a licence to operate a general-type pharmacy on the basis of a competition regarding opening of a new day-and-night general-type pharmacy in accordance with the laws and regulations regarding location of pharmacies has not ensured day-and-night operation of such pharmacy (revoking of licence shall be applied);

68.15. the relevant licence of a general-type pharmacy has been suspended in accordance with Sub-paragraph 62.14 of this Regulation and the licensed person has not rectified the infringements established by the Inspectorate within six months.

[25 June 2013]

V. Information in the Licence and the Amount of the State Fee

69. The licence referred to in Sub-paragraphs 4.1 and 4.2 of this Regulation shall be drawn up in accordance with Annex 6 to this Regulation. The licence referred to in Sub-paragraph 4.3 of this Regulation shall be drawn up in accordance with Annex 6.1 to this Regulation.

[25 June 2013]

70. The following authorised conditions of a special activity shall be indicated in annex to the licence referred to in Sub-paragraph 4.1 of this Regulation for the operations of a general-type pharmacy:

70.1. distribution of psychotropic medicinal products;

70.2. distribution of psychotropic substances;

70.3. distribution of narcotic medicinal products and of psychotropic medicinal products considered as equivalent thereto;

70.4. distribution of narcotic substances and of psychotropic substances considered as equivalent thereto;

70.5. preparation of medicinal products in a pharmacy;

70.6. distribution of non-prescription medicinal products, using website;

70.7. distribution of veterinary medicinal products;

70.8. open day-and-night;

70.9. distribution of non-prescription veterinary medicinal products, using website.

[25 June 2013; 26 January 2016 / Sub-paragraph 70.9 shall come into force on 1 March 2016. See Paragraph 2 of amendments]

70.1 It shall be permitted to indicate the condition of a special activity referred to in Sub-paragraph 70.9 of this Regulation in annex to the licence for the operation of a general-type pharmacy only in case if the condition of a special activity referred to in Sub-paragraph 70.7 of this Regulation is ensured concurrently.

[26 January 2016 / Paragraph shall come into force on 1 March 2016. See Paragraph 2 of amendments]

71. The following authorised conditions of a special activity shall be indicated in annex to the licence referred to in Sub-paragraph 4.2 of this Regulation for the operation of a closed-end type pharmacy:

71.1. distribution of psychotropic medicinal products;

71.2. distribution of psychotropic substances;

71.3. distribution of narcotic medicinal products and of psychotropic medicinal products considered as equivalent thereto;

71.4. distribution of narcotic substances and of psychotropic substances considered as equivalent thereto;

71.5. preparation of medicinal products in a pharmacy;

72. The following authorised conditions of a special activity shall be indicated in annex to the licence referred to in Sub-paragraph 4.3 of this Regulation to operate a medicinal product wholesaler:

72.1. distribution of psychotropic medicinal products;

72.2. distribution of psychotropic substances;

72.3. distribution of narcotic medicinal products and of psychotropic medicinal products considered as equivalent thereto;

72.4. distribution of narcotic substances and of psychotropic substances considered as equivalent thereto;

72.5. distribution of spirits;

72.6. distribution of veterinary medicinal products;

72.7. [16 December 2014];

72.8. distribution of immunological preparations;

72.9. distribution of blood products;

72.10. distribution of radiopharmaceutical preparations (including radionuclide sets);

72.11. distribution of medical gas;

72.12. distribution of cold chain products (which require storage in low temperature).

[16 December 2014]

73. The licence referred to in:

73.1. Sub-paragraph 4.4 of this Regulation shall be drawn up in accordance with Annex 7 to this Regulation. If the licence holder manufactures or imports narcotic or psychotropic medicinal products, the given name and surname of the official (officials) responsible for the condition of a special activity, as well as the following conditions of the special activity shall be indicated in annex to the licence:

73.1.1. manufacturing of narcotic medicinal products and of psychotropic medicinal products considered as equivalent thereto;

73.1.2. importing of narcotic medicinal products and of psychotropic medicinal products considered as equivalent thereto;

73.1.3. manufacturing of psychotropic medicinal products;

73.1.4. importing of psychotropic medicinal products;

73.2. Sub-paragraph 4.5 of this Regulation shall be drawn up in accordance with Annex 8 to this Regulation. If the licence holder manufactures controlled substances, the given name and surname of the responsible official (responsible officials), as well as the precise condition of a special activity shall be indicated in the licence:

73.2.1. manufacturing of narcotic substances;

73.2.2. manufacturing of psychotropic substances.

74. The licence and its annexes shall be signed by the director of the Agency. The number, type, date of issue of the licence and name of the licence holder shall be indicated in footer of each page of the licence.

75. The amount (rate) of the State fee for issuing of a licence shall be the following:

75.1. for the operation of a general-type pharmacy:

75.1.1. in towns - EUR 284.57;

75.1.2. outside towns - EUR 42.69;

75.2. for the operation of a medicinal product wholesaler - EUR 426.86;

75.3. for the manufacturing of medicinal products or veterinary medicinal products, or active pharmaceutical substances (including controlled substances) - EUR 711.44;

75.4. for the performance of partial manufacturing process (re-packaging, re-labelling) of medicinal products or veterinary medicinal products in a medicinal products wholesaler - EUR 426.86;

75.5. for the manufacturing or importing of investigational medicinal products or controlled substances - EUR 142.29;

75.6. for the importing of medicinal products - EUR 284.57.

[27 August 2013]

76. The State fee for re-registration of a licence shall be 10 per cent from the State fee determined in Paragraph 75 of this Regulation. Revenue from the State fee shall be transferred into the State basic budget.

77. The Agency shall post information on licence holders on its website and indicate:

77.1. the firm name or given name and surname of the performer of economic activity, as well as the name of the object of pharmaceutical or veterinary pharmaceutical activity, if it is different from the firm name or given name and surname of the performer of economic activity;

77.2. the legal address of the merchant and the registration number in the Commercial Register, but for the performer of economic activity - the address of the declared place of residence;

77.3. address of the site of pharmaceutical activity;

77.4. the licence number and term of validity, the date of taking the decision;

77.5. information on the conditions of a special activity;

77.6. the given name and surname of the manager of the pharmacy or the responsible official of the medicinal product wholesaler, or of the qualified person of the manufacturer or importer of medicinal products, or - in respect of manufacturing of active substances - of the responsible official;

77.7. information on suspending the operation of the licence and the date and term of taking the decision;

77.8. information on renewal of the operation of the licence and the date of taking the decision;

77.9. information on revoking the licence and the date of taking the decision;

77.10. in addition the field of operation of the licence shall be indicated for a licence to manufacture medicinal products or active substances:

77.10.1. manufacturing of medicinal products for human use;

77.10.2. importing of medicinal products for human use;

77.10.3. manufacturing of veterinary medicinal products;

77.10.4. importing of veterinary medicinal products;

77.10.5. manufacturing of investigational medicinal products;

77.10.6. importing of investigational medicinal products;

77.10.7. partial manufacturing operations (only packaging (re-packaging) and re-labelling of medicinal products or veterinary medicinal products);

77.10.8. manufacturing of active substances;

77.11. information on the site regarding which the submission referred to in Paragraph 16 of this Regulation has been submitted to the Agency regarding a wish to open a new pharmacy or a branch of a pharmacy or move it, indicating whether day-and-night operation or preparation of medicinal products is intended - the date of submitting of the submission to the Agency, registration sequence number, address of premises (location) and intended activity (opening of a pharmacy and a branch of a pharmacy, moving thereof and commencement of day-and-night operation and preparation of medicinal products), without indicating the submitter. The Agency shall remove the abovementioned information from the website if a decision to reject the location of the pharmacy or the branch of the pharmacy is taken;

77.12. information on the place on which the Agency has taken the decision referred to in Paragraph 19 of this Regulation on the location of the pharmacy or the branch of the pharmacy - the date of issue of the decision, the location of the pharmacy and the branch of the pharmacy and the intended activity - opening of a new pharmacy and a branch of the pharmacy, moving thereof and commencement of day-and-night operation and preparation of medicinal products, without indicating the submitter;

77.13. information on general-type pharmacies regarding which the submission referred to in Paragraph 15 of this Regulation regarding re-registering of the licence to operate a pharmacy in relation to commencement of day-and-night operations or preparation of medicinal products is submitted - the date of submitting the submission to the Agency, the address of premises (location) and the intended condition of a special activity (commencement of day-and-night operations and preparation of medicinal products), without indicating the submitter.

[25 June 2013]

VI. Duties of Institutions and the Licence Holder

78. The Agency shall:

78.1. create, maintain and update a database regarding the manufactured and imported medicinal products (type of activity), veterinary medicinal products, controlled substances and active substances (production), which are indicated in the licence file. The type, name, form, dose thereof, as well as the type of activity and information on medicinal products, veterinary medicinal products, investigational medicinal products, controlled substances and active substances the manufacturing or importing of which is suspended shall be indicated in the database;

78.2. co-operate with the Inspectorate and - in the case referred to in Sections 45.1and 51.2 of the Pharmaceutical Law - with the Food and Veterinary Service (also, when infringements are established during an inspection of conformity assessment);

78.3. prepare instructions for rectification of deficiencies and follow the performance deadlines thereof;

78.4. if infringements are established in the manufacturing, importing or distribution, initiate suspending or revoking the operation of the licence;

78.5. ensure the possibility for officials of the Inspectorate and - in the case referred to in Sections 45.1 and 51.2 of the Pharmaceutical Law - officials of the Food and Veterinary Service to become familiar with the information related to conformity assessment;

78.6. on the next working day after suspending or revoking of the licence inform the State Revenue Service and the Food and Veterinary Service thereof;

78.7. enter information on licences to manufacture or import medicinal products and to operate a medicinal product wholesaler in the European Union database regarding manufacturing and importing licences and good manufacturing practice certificates (Eudra GMDP database);

78.8. upon request of the European Commission or the competent authority of the European Union Member State provide information on inclusion of the licences referred to in Sub-paragraph 78.7 of this Regulation in the European Union database regarding manufacturing and importing licences and good manufacturing practice certificates (Eudra GMDP database);

78.9. inform the European Commission and competent authorities of the European Union Member States regarding suspended or revoked licences to operate a medicinal product wholesaler;

78.10. provide the following information to the Food and Veterinary Service:

78.10.1. on the issued licences referred to in Sub-paragraph 1.1 of this Regulation;

78.10.1.1 on the issued licences for the operation of a general-type pharmacy for which distribution of veterinary medicinal products and distribution of non-prescription veterinary medicinal products using website has been indicated as the condition of a special activity, as well as in addition provide information regarding the personnel in accordance with Sub-paragraph 16.7.1 of Annex 5 to this Regulation;

78.10.2. on the issued special authorisations (licences) for manufacturers of medicinal products that concurrently manufacture or import also veterinary medicinal products, and for medicinal product wholesalers for which the distribution of veterinary medicinal products is indicated as the condition of a special activity, the following information shall be provided additionally:

78.10.2.1. [16 December 2014];

78.10.2.2. on the relevant licences the operation of which is suspended or revoked.

[25 June 2013; 26 January 2016 / Sub-paragraph 78.10.1.1 shall come into force on 1 March 2016. See Paragraph 2 of amendments]

79. The Inspectorate and - in the case referred to in Sections 45.1 and 51.2 of the Pharmaceutical Law - the Food and Veterinary Service shall:

79.1. control the operation of the licence holder;

79.2. provide instructions for rectification of infringements and deficiencies and follow the performance deadlines thereof;

79.3. after detection of infringements provide proposals in writing to the Agency regarding suspending or revoking of the licence;

79.4. co-operate with the Agency in issues related to conformity assessment;

79.5. inform the competent authorities of the European Union Member States and the European Commission, if it is established that a person who is operating in the territory of the Republic of Latvia with an authorisation for wholesale of medicinal products issued by another European Union Member State fails to fulfil the conditions referred to in the authorisation. According to the information provided by the competent authority of another European Union Member State inform the Agency on a licensed person operating in the territory of the particular Member State for which a licence is issued in Latvia that gives the right to engage in wholesale of medicinal products, and which, according to the information provided by the competent authority of the relevant Member State, fails to comply with the conditions referred to in the licence, as well as inform the competent authority of the relevant European Union Member States and the European Commission on the decisions taken and justification of such decisions.

80. After receipt of the information referred to in Sub-paragraph 78.10 of this Regulation the Food and Veterinary Service shall include the merchants who have received licences to operate a pharmacy and licences to operate a medicinal product wholesaler in the Register of Food Distributors that gives the right to the merchant, on the basis of the relevant licence, to distribute the foodstuffs referred to in Paragraph 7 of this Regulation without obtaining a certificate from the Food and Veterinary Service. The abovementioned norm also applies to performers of economic activity.

81. The licence holder shall:

81.1. ensure the operation in conformity with the information indicated in the licence and annexes thereto, the conditions of a special activity and the requirements laid down in the laws and regulations governing pharmacy and veterinary pharmacy, trade in narcotic and psychotropic substances and medicinal products;

81.2. ensure that manufacturing, importing and distribution of medicinal products or veterinary medicinal products, or investigational medicinal products, manufacturing and distribution of controlled substances and active substances and pre-packaging of spirits are conducted only in those premises which are indicated in the licence file;

81.3. ensure the possibility for officials of the Inspectorate and - in the case referred to in Section 45.1 or 51.2 of the Pharmaceutical Law - officials of the Food and Veterinary Service to enter the premises at any time and in conformity with the competence to control the manufacturing, importing and distribution operations of medicinal products, veterinary medicinal products or investigational medicinal products, as well as for the officials of the Inspectorate - trade in narcotic and psychotropic medicinal products, controlled substances and active substances and documentation related thereto;

81.4. ensure the possibility for officials of the Agency to enter the premises at any time and carry out conformity assessment inspections thereof, including inspection of conformity of good manufacturing practice or good distribution practice of medicinal products;

81.5. carry out record-keeping of received and supplied medicinal products, veterinary medicinal products, investigational medicinal products and controlled substances and control of record-keeping in accordance with the laws and regulations regarding distribution of medicinal products and veterinary medicinal products and the laws and regulations governing trade in narcotic and psychotropic substances and medicinal products;

81.6. provide the information that is laid down in the laws and regulations governing pharmacy or veterinary pharmacy to the Agency, the Inspectorate and the Food and Veterinary Service;

81.7. upon request of the officials of the Agency and Inspectorate, on the basis of the interests of the public health, provide information on operation;

81.8. according to the decision of the Agency to issue or re-register the licence in another site of operation or to renew the operation of the licence, commence the relevant licensed operation not later than within a year after taking of the relevant decision and notify the Agency regarding commencement of the operation within two working days (this shall apply to the licence to operate a medicinal product wholesaler, the licence to manufacture or import medicinal products, and the licence to manufacture active substances or controlled substances);

81.9. according to the decision of the Agency to issue or re-register the licence in another site or to renew the operation of the licence, commence the relevant licensed operation on the next day after entering into effect of the decision to issue, re-register or renew the operation of the licence (this shall apply to pharmacies to be newly opened or moved pharmacies or if the operation of the pharmacy is renewed);

81.10. ensure that the plan of the premises, complete documentation governing internal working order, including job descriptions of employees of the pharmacy and branch of the pharmacy, internal regulations and instructions in accordance with the laws and regulations regarding operation of pharmacies are kept in the pharmacy and branch of the pharmacy and made available to officials of the Inspectorate;

81.11. ensure that pharmaceutical operation is carried out in public buildings, parts thereof or groups of premises put into service (this shall apply to general-type pharmacies);

81.12. ensure that the entrance (exit) in a general-type pharmacy intended for customers in a customer servicing area is suitable for entering with a wheelchair and baby stroller. If reconstruction or renovation of the building must be performed in a pharmacy for ensuring of the accessibility of the environment and:

81.12.1. the relevant requirements are technically impossible to be conformed to or due to conforming to them the building would lose its cultural and historical value, the accessibility of the environment may be ensured by alternative technical solutions (this shall not apply to pharmacies to be newly opened and moved pharmacies);

81.12.2. a pharmacy is located in a municipality, a municipality town or a municipality rural territory where the number of inhabitants does not exceed 4000, the accessibility of the environment may be ensured by alternative technical solutions.

[25 June 2013]

82. In addition to that referred to in Paragraph 81 of this Regulation the licence holder for the manufacturing of medicinal products or active substances (including controlled substances) shall:

82.1. ensure that only those medicinal products, veterinary medicinal products, investigational medicinal products and forms thereof, controlled substances and active substances are manufactured or imported which are indicated in the licence file and included in the database of the Agency;

82.2. handle authorised medicinal products, veterinary medicinal products, investigational medicinal products, controlled substances and active substances only in accordance with the laws and regulations regarding manufacturing of medicinal products or veterinary medicinal products, bringing in and bringing out of medicinal products and distribution of medicinal products or veterinary medicinal products and trade in narcotic and psychotropic medicinal products and controlled substances;

82.3. ensure that the personnel conforming to the requirements laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products, or investigational medicinal products, or - in respect of substances - the requirements laid down in the laws and regulations governing trade in narcotic and psychotropic medicinal products and controlled substances;

82.4. notify the Agency in advance regarding all changes that he or she wishes to make in the information submitted in accordance with the submission referred to in Annex 1 to this Regulation (especially - if the person referred to in Sub-paragraphs 10.5 and 11.2.6 of this Regulation is changed);

82.5. ensure that the qualified person has a possibility to perform duties (for example, by transferring at the disposal thereof all necessary devices and equipment) that are laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products;

82.6. comply with the principles of good manufacturing practice in the manufacturing and control of medicinal products, veterinary medicinal products, investigational medicinal products, controlled substances and active substances, which are laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products and active substances, and the guidelines of good manufacturing practice of the European Commission, as well as use only such active substances as raw materials which are manufactured in accordance with the guidelines of good manufacturing practice of active substances;

82.7. draw up a description of the manufacturing plant (Annex 2). A description of the manufacturing plant is a document that is drawn up within the framework of the manufacturer's quality management system and updated on a regular basis. It shall contain specific information on management policy and actions at the manufacturing plant, on manufacturing and quality control operations at the relevant manufacturing plant and on any closely integrated operation in the adjacent buildings, and provide clear information on operations of the manufacturer in respect of good manufacturing practice that may be used for general supervision, as well as in order to plan and carry out the inspections of good manufacturing practice efficiently. If only part of the manufacturing process is carried out at the manufacturing plant, the actions that are carried out at the particular manufacturing plant, for example, analysis, packaging, shall be indicated in the description of the manufacturing plant. The description of the manufacturing plant shall contain version number, date from which it enters into effect, and date until which it must be revised. The description of the manufacturing plant shall be revised on a regular basis in order to ensure that it is updated and demonstrates current operations. Each annex included in the description of the manufacturing plant may have different date of entering into effect, in order for it to be possible to update each of them separately.

[25 June 2013]

83. A decision of the Agency to refuse to issue a license, to revoke a licence, to re-register or to suspend the operation of a licence may be contested in accordance with the procedures laid down in the Administrative Procedure Law by submitting a relevant submission to the Ministry of Health. A decision of the Ministry of Health may be appealed to the court in accordance with the procedures laid down in laws and regulations.

VII. Closing Provisions

84. Cabinet Regulation No. 313 of 30 March 2010, Procedures for Licensing of Pharmaceutical Activity (Latvijas Vēstnesis, 2010, No. 52; 2011, No. 11), is repealed.

85. The licences to operate a pharmacy and to operate a medicinal product or veterinary medicinal product wholesaler, which have been granted until the day of coming into force of this Regulation, shall be in effect, however, they shall be re-registered when repeat conformity assessment is carried out (this shall apply to a medicinal product or veterinary medicinal product wholesaler) or if there are changes in the submitted information and documents on the basis of which the licence was issued in accordance with the requirements laid down in this Regulation. The abovementioned re-registration shall not apply to the licences to operate a pharmacy in which the condition of a special activity is included - distribution of medicinal products wholesale for medicinal treatment institutions and social care institutions (ensuring the requirements of good distribution practices of medicinal products).

86. Persons for whom the licences to operate a pharmacy or to operate a medicinal product or veterinary medicinal product wholesaler are issued with definite term of validity until the day of coming into force of this Regulation, shall submit a submission for conformity assessment (this shall apply to medicinal product or veterinary medicinal product wholesaler) and for re-registering of the licence not later than 30 days before the end of the term of validity of the licence in accordance with the procedures laid down in this Regulation.

87. The licences to manufacture or import medicinal products or veterinary medicinal products, which have been granted until the day of coming into force of this Regulation, shall be in effect, however, they shall be re-registered, if repeat conformity assessment is carried out or if there are changes in the submitted information and documents on the basis of which the licence was issued in accordance with the requirements laid down in this Regulation, taking into account the conditions referred to in Paragraph 88 of this Regulation.

88. Persons who have a licence to manufacture or import medicinal products or veterinary medicinal products and who manufacture or import narcotic or psychotropic medicinal products, but for whom the abovementioned activities have not been indicated as a separate condition of a special activity in Annex 8 to the relevant licence, are entitled to continue the relevant activity on the basis of the existing licence to manufacture or import medicinal products until re-registering the licence to manufacture or import medicinal products. When re-registering a licence to manufacture or import medicinal products, the Agency shall indicate the relevant condition of a special activity referred to in Sub-paragraph 73.1 of this Regulation in Annex 8 to the licence.

89. The plan of premises referred to in Sub-paragraph 3.1 of Annex 2, Sub-paragraph 10.2 of Annex 4 and Sub-paragraph 18.6 of Annex 5 to this Regulation may be applied instead of the plan of premises of the inventory file in respect of submissions regarding issuing or re-registering of a licence, which are submitted to the Agency and which are assessed by the Agency and regarding which the decision referred to in Paragraph 51 of this Regulation has not been taken.

90. A merchant is entitled to submit the plan of premises of the inventory file to the Agency instead of the plan of premises referred to in Sub-paragraph 10.2 of Annex 4 and Sub-paragraph 18.6 of Annex 5 to this Regulation.

91. Sub-paragraph 81.10 of this Regulation shall come into force on 1 December 2011.

92. Sub-paragraph 81.12.1 of this Regulation in respect of pharmacies to be moved shall be applied from 1 March 2012.

93. The licensed medicinal product wholesalers shall, upon request of the Agency, issue to the Agency the information referred to in Annex 1 of Annex 6.1 to this Regulation, unless it is included in the licence issued or in the submission for receipt of the licence, or is indicated in the information provided regarding changes.

[16 December 2014]

Informative Reference to the European Union Directives

[25 June 2013]

This Regulation contains legal norms arising from:

1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;

2) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use;

3) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products;

4) Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products;

5) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;

6) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products;

7) Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

Prime Minister V. Dombrovskis

Minister for Health J. Bārzdiņš

 

Annex 1
Cabinet Regulation No. 800
19 October 2011

[25 June 2013]

Submission for Conformity Assessment and Issuing (Re-registering) of Special Authorisation (Licence):

 

for the manufacturing or importing of medicinal products

for manufacturing of controlled substances

for pre-packaging of spirits
(mark as appropriate with an x)

To the State Agency of Medicines

1. Information on the submitter:

1.1. company
1.2. legal address of the merchant and office address thereof (if different from the legal address)
1.3. registration number in the Commercial Register
1.4. name of the undertaking of pharmaceutical activity
1.5. address of the site of pharmaceutical activity
1.6. special authorisation (licence) number (if any)
1.7. telephone
1.8. fax
1.9. e-mail address (if any)
1.10. website
1.11. for the performer of economic activity:
1.11.1. given name and surname
1.11.2. personal identity number
1.11.3. address of the declared place of residence
1.12. information on other sites of pharmaceutical activity:
1.12.1. address
1.12.2. given name and surname of the responsible official
1.12.3. telephone
1.12.4. fax
1.12.5. e-mail address (if any)

Note. If an undertaking has several sites of pharmaceutical activity, the information referred to in Sub-paragraph 1.12 of this Annex regarding other sites and responsible officials shall be indicated on a separate sheet of paper and appended to the submission.

2. Please issue a special authorisation (licence) (mark with an "x" as appropriate):

2.1. for the manufacturing of medicinal products

2.2. for the importing of medicinal products

2.3. for the manufacturing of veterinary medicinal products

2.4. for the importing of veterinary medicinal products

2.5. for the manufacturing of investigational medicinal products

2.6. for the importing of investigational medicinal products

2.7. for the manufacturing of controlled substances

2.8. for the pre-packaging of spirits

3. Please re-register a special authorisation (licence) due to (mark with an "x" as appropriate):

3.1. the change of the name of the holder of the special authorisation (licence)

3.2. the change of legal address of the holder of the special authorisation (licence)

3.3. the change of the site of the pharmaceutical activity

3.4. significant changes in the methods of manufacturing or quality control

3.5. changes in the importing activities

3.6. the performance of activities of the manufacturing of medicinal products or substances on the basis of a contract or the change of contracting manufacturers

3.7. the performance of quality control of medicinal products or substances on the basis of a contract or the change of the person with whom a contract regarding quality control of medicinal products has been entered into

3.8. the change of the qualified person

3.9. the change of the head of the manufacturing unit

3.10. the change of the head of the quality control unit

3.11. the commencement of a new type of a special activity

3.12. the change of the official responsible for the type of a special activity

3.13. the commencement of manufacturing of a new pharmaceutical form or type of medicinal products

3.14. the commencement of importing of a new pharmaceutical form or type of medicinal products

3.15. other reason

Note. Sub-paragraphs 3.8, 3.13, and 3.14 of this Annex shall not apply to the submission for manufacturing of controlled substances and pre-packaging of spirits.

4. Information on the qualified person:

4.1. given name and surname
4.2. personal identity number
4.3. qualification
4.4. experience
4.5. contact address
4.6. telephone
4.7. fax
4.8. e-mail address (if any)

Notes.

1. A copy of the education document and CV shall be appended in annex.

2. This shall not apply to a submission for manufacturing of controlled substances and pre-packaging of spirits.

5. Information on the responsible officials:

5.1. head of the manufacturing unit of medicinal products:

5.1.1. given name and surname
5.1.2. personal identity number
5.1.3. detailed information on responsibility
5.1.4. contact address
5.1.5. telephone
5.1.6. fax
5.1.7. e-mail address (if any)

5.2. head of the quality control unit of medicinal products:

5.2.1. given name and surname
5.2.2. personal identity number
5.2.3. detailed information on responsibility
5.2.4. contact address
5.2.5. telephone
5.2.6. fax
5.2.7. e-mail address (if any)

Note. A copy of the education document and CV of each responsible person shall be appended in annex. If several persons are responsible for the manufacturing operations, the information referred to in Paragraph 5 of this Annex regarding each person shall be provided in Annex on a separate sheet of paper.

6. Information on the type of a special activity - activity involving psychotropic substances and medicinal products:

6.1. information on the type of activity (mark with an "x" as appropriate):

6.1.1. manufacturing of psychotropic medicinal products

6.1.2. importing of psychotropic medicinal products

6.1.3. manufacturing of psychotropic substances

6.2. information on the responsible official:

6.2.1. given name and surname of the responsible official
6.2.2. personal identity number
6.2.3. telephone
6.2.4. given name and surname of the deputy responsible official (if any)
6.2.5. personal identity number

Note. A copy of the education document and CV of each responsible person shall be appended in annex.

7. Information on the type of a special activity - activity involving narcotic substances and medicinal products (and psychotropic substances and medicinal products considered as equivalent thereto):

7.1. information on the type of activity (mark with an "x" as appropriate):

7.1.1. manufacturing of narcotic medicinal products

7.1.2. importing of narcotic medicinal products

7.1.3. manufacturing of narcotic medicinal products

7.2. information on the responsible official:

7.2.1. given name and surname of the responsible official
7.2.2. personal identity number
7.2.3. telephone
7.2.4. given name and surname of the deputy responsible official (if any)
7.2.5. personal identity number
7.2.6. telephone

Note. A copy of the education document and CV of each responsible person shall be appended in annex.

8. Information on contract manufacturer and manufacturing site*:

8.1. name of the undertaking
8.2. legal address
8.3. the number, date, issuer of the special authorisation for the manufacturing of medicinal products
8.4. address of the manufacturing site  
8.5. name of the manufacturing plant  
8.6. given name, surname of the responsible official  
8.7. telephone  
8.8. fax    

Note. If an undertaking has several contract manufacturers or contract manufacturing sites, the information referred to in Paragraph 8 of this Annex shall be appended on a separate sheet of paper for each site and responsible official.

9. Information on the laboratory which conducts quality control on the basis of a contract and which conforms to the requirements laid down in the laws and regulations regarding manufacturing and control of medicinal products or veterinary medicinal products*:

9.1. name of the laboratory
9.2. address
9.3. given name and surname of the responsible official
9.4. telephone
9.5. fax  

Note. If an undertaking has several laboratories with which a contract regarding performance of quality control has been entered into, the information referred to in Paragraph 9 of this Annex shall be appended on a separate sheet of paper for each laboratory.

10. Information on manufacturing or importing activities (mark with an "x" as appropriate):

10.1. manufacturing of medicinal products for human use

10.1.1. complete manufacturing of medicinal products

10.1.2. partial manufacturing of medicinal products (including re-packaging, re-prepacking, re-labelling)

10.2. importing of medicinal products for human use

10.3. manufacturing of veterinary medicinal products

10.3.1. complete manufacturing of veterinary medicinal products

10.3.2. partial manufacturing of veterinary medicinal products (including re-packaging, re-prepacking, re-labelling)

10.4. importing of veterinary medicinal products

10.5. manufacturing of investigational medicinal products

10.6. importing of investigational medicinal products

10.7. manufacturing of substances

11. Information on manufacturing of sterile pharmaceutical forms*:

Specify the name of the medicinal products next to the corresponding pharmaceutical form or type of medicinal product.

11.1. aseptically prepared (list of medicinal products)

11.1.1. large volume liquids  
11.1.2. lyophilisates
11.1.3. semi-solids  
11.1.4. small volume liquids  
11.1.5. solids and implants  
11.1.6. other aseptically prepared products (free text)  

11.2. terminally sterilised (list of medicinal products)

11.2.1. large volume liquids  
11.2.2. semi-solids  
11.2.3. small volume liquids  
11.2.4. solids and implants  
11.2.5. other terminally sterilised finished products (free text)  

11.3. batch certification only (list of medicinal products)

11.4. manufacturing of sterile controlled substances*

Note. This shall not apply to a submission for pre-packaging of spirits.

12. Information on manufacturing of non-sterile pharmaceutical forms*:

Specify the name of the medicinal products next to the corresponding pharmaceutical form or type of medicinal product.

12.1. non-sterile pharmaceutical forms (list of medicinal products)

12.1.1. capsules, hard shell  
12.1.2. capsules, soft shell  
12.1.3. chewing gums  
12.1.4. impregnated matrices  
12.1.5. liquids for external use  
12.1.6. liquids for internal use  
12.1.7. medicinal gases  
12.1.8. other solid dosage forms  
12.1.9. pressurised preparations (under pressure)  
12.1.10. radionuclide generators  
12.1.11. semi-solids  
12.1.12. suppositories  
12.1.13. tablets  
12.1.14. transdermal patches  
12.1.15. intraruminal devices  
12.1.16. veterinary premixes  
12.1.17. other non-sterile pharmaceutical forms (free text)  

12.2. batch certification only (list of medicinal products)

12.3. manufacturing of non-sterile controlled substances*

Note. This shall not apply to a submission for pre-packaging of spirits.

13. Information on manufacturing of biological medicinal products or batch certification*:

Specify the name and pharmaceutical form of the medicinal products next to each medicinal product.

13.1. manufacturing of biological medicinal products (list of medicinal products)

13.1.1. blood products  
13.1.2. immunological products  
13.1.3. cell therapy products  
13.1.4. gene therapy products  
13.1.5. biotechnology products  
13.1.6. human or animal extracted products  
13.1.7. other biological medicinal products (free text)  

13.2. batch certification only (list of medicinal products)

13.2.1. blood products  
13.2.2. immunological products  
13.2.3. cell therapy products  
13.2.4. gene therapy products  
13.2.5. biotechnology products  
13.2.6. human or animal extracted products  
13.2.7. tissue engineered products  
13.2.8. other biological medicinal products (free text)  

Note. This shall not apply to a submission for pre-packaging of spirits.

14. Information on other manufactured products or production activities*:

Indicate other types of manufacturing activity or of medicinal products that are not referred to in Paragraphs 11, 12, and 13 of this Annex. Specify the name and pharmaceutical form of medicinal products next to the corresponding type of medicinal products.

14.1. manufacturing of other products (list of medicinal products)

14.1.1. herbal medicinal products  
14.1.2. [25 June 2013]  
14.1.3. homeopathic medicinal products  
14.1.4. [25 June 2013]  
14.1.5. other (free text)  

14.2. sterilisation of active substances or excipients, or finished products

If sterilisation is performed with the relevant method, the name of active substance or finished product shall be indicated.

14.2.1. filtration  
14.2.2. dry heat  
14.2.3. moist heat  
14.2.4. chemical  
14.2.5. gamma irradiation  
14.2.6. electron beam  
14.2.7. other (free text)  

15. Information on partial manufacturing - only packaging activities*:

If only packaging is performed, the name of medicinal products shall be indicated next to the corresponding pharmaceutical form.

15.1. primary packaging

15.1.1. capsules, hard shell  
15.1.2. capsules, soft shell  
15.1.3. impregnated matrices  
15.1.4. liquids for external use  
15.1.5. liquids for internal use  
15.1.6. medicinal gases  
15.1.7. other solid dosage forms  
15.1.8. pressurised preparations (under pressure)  
15.1.9. radionuclide generators  
15.1.10. semi-solids  
15.1.11. suppositories  
15.1.12. tablets  
15.1.13. transdermal patches  
15.1.14. intraruminal devices  
15.1.15. veterinary premixes  
15.1.16. other non-sterile pharmaceutical forms (free text)  

15.2. secondary packaging (list of medicinal products)

16. Information on quality control (mark with an "x" as appropriate):

for imported medicinal products

16.1. microbiological: sterility

16.2. microbiological: purity of non-sterile pharmaceutical forms

16.3. chemical or physical

16.4. biological

for spirits

for controlled substances

17. Information on batch certification of imported medicinal products*:

If batch certification of imported medicinal products is performed, the name of the medicinal products shall be indicated next to the corresponding pharmaceutical form.

17.1. sterile pharmaceutical forms

17.1.1. aseptically prepared  
17.1.2. terminally sterilised  

17.2. non-sterile pharmaceutical forms (list of pharmaceutical forms)

17.3. biological medicinal products

17.3.1. blood products  
17.3.2. immunological products  
17.3.3. cell therapy products  
17.3.4. gene therapy products  
17.3.5. biotechnology products  
17.3.6. human or animal extracted products  
17.3.7. tissue engineered products  
17.3.8. other biological medicinal products  

17.4. other significant importing activities

17.4.1. radiopharmaceutical products or radionuclide generators  
17.4.2. medicinal gases  
17.4.3. herbal medicinal products  
17.4.4. homeopathic medicinal products  
17.4.5. biologically active starting material  
17.4.6. other (free text)  

17.1 Importing activities (mark with an "x" as appropriate):

17.1 1. site of physical importation

17.1 2. importation of intermediate which undergoes further processing

Note. This shall not apply to a submission for manufacturing of controlled substances and pre-packaging of spirits.

18. The following documents are appended to the submission (mark as appropriate with an x):

18.1. a document attesting the right of the submitter to use premises (certified copy) - on ______pages

18.2. a statement regarding employment legal relationships of the employer and the officials referred to in Paragraphs 4 and 5 of this Annex, duration thereof, work performed by the employee, documents which confirm appointing of the person to the relevant position (certified copies), on _____ pages

18.3. an education document (certified copies) and CV of the persons referred to in Paragraphs 4 and 5 of this Annex, for the qualified person - also a diploma and annex thereof (certified copies) and documents attesting experience in accordance with the regulations regarding procedures for manufacturing of medicinal products on ______ pages

18.4. an order regarding appointing of the person responsible for trade in narcotic and psychotropic substances and medicinal products (certified copy) and an attestation of the submitter that founders (to be listed) and members (to be listed) thereof comply with the requirements referred to in Section 11, Clause 2 of the law On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, on _________ pages

18.5. a written attestation of the official responsible for trade in narcotic or psychotropic substances and medicinal products that a person complies with the requirements referred to in Section 11, Clauses 1 and 3 of the law On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, on _______ pages

18.6. organisational scheme of the manufacturing and quality control in which the administrative subordination of officials according to the functional duties is indicated on ____ pages

18.7. a description of the manufacturing plant of medicinal products on ____ pages**

18.8. a list of manufactured medicinal products or substances on ______ pages**

18.9. a list of imported medicinal products on _______ pages**

18.10. a receipt regarding payment of the State fee

18.11. other additional information (indicate what kind) on ____ pages

18.12. a document by which the merchant or performer of economic activity authorises the person to submit a submission and documents to the State Agency of Medicines, on _______ pages

Notes.

1. Sub-paragraphs 18.3 and 18.9 of this Annex shall not apply to a submission for manufacturing of controlled substances, whereas Sub-paragraphs 18.6 and 18.7 shall not apply to a submission for manufacturing of controlled substances if the person requesting a licence to manufacture controlled substances has not requested conformity assessment of good manufacturing practice.

2. Sub-paragraphs 18.3, 18.4, 18.5, 18.6, 18.7, 18.8, and 18.9 of this Annex shall not apply to a submission for pre-packaging of spirits.

19. I hereby attest that the information provided in the submission, the documents appended to the submission and other information is complete and true, and it conforms to the requirements laid down in the Cabinet Regulation No. 800 of 19 October 2011, Procedures for the Licensing of Pharmaceutical Activity:

19.1. given name and surname
19.2. position
19.3. address
19.4. telephone number, fax, e-mail
 

(place, date***)

 

(signature***)

 

(signature of the person with the right of representation)


Notes.

1. * Delete those Paragraphs and Sub-paragraphs which do not apply.

2. ** May be submitted in an electronic form.

3. *** The detail of the document "signature" shall not be completed if the document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

Minister for Health J. Bārzdiņš

 

Annex 2
Cabinet Regulation No. 800
19 October 2011

Description of the Manufacturing Plant

[25 June 2013]

Version number of the description of the manufacturing plant ____________, date of entering into effect________________________

No.

Requirements

Instructions

1. GENERAL INFORMATION ON MANUFACTURER
1.1. Contact information of the manufacturer - Firm name of the merchant (or for the performer of economic activity - name) and legal address.

- Names and addresses of the manufacturing plant, buildings and production units present therein.

- Contact information of the manufacturer, including day-and-night telephone number of contact personnel for communication, if defects are detected for the product or it is necessary to be recalled.

- Identification number of the manufacturing plant, for example, co-ordinates of the Global Positioning System (GPS) or co-ordinates of any other geographic positioning system, number of the Data Universal Numbering System (D-U-N-S) (a unique identification number which is granted by the firm Dun&Bradstreet). A reference to D-U-N-S is necessary if it is a description regarding manufacturing plants which are located outside the European Union and European Economic Area.

1.2. Manufacturing activities authorised for the manufacturing plant - A reference to the special authorisation (licence) issued by the State Agency of Medicines or a valid manufacturing authorisation (licence) issued by a competent authority of another state (a copy appended to Annex 1 to the description of the manufacturing plant) or a reference to the European Union database regarding manufacturing and importing licences and good manufacturing practice certificates managed by the European Medicines Agency (hereinafter - Eudra GMDP database), where applicable. If the competent authority does not carry out licensing of the manufacturing of medicinal products, it shall be indicated.

- A short description of the manufacturing, importing, export, distribution and other activities licenced by the relevant competent authority, including foreign competent authority, indicating the licensed pharmaceutical forms/activities accordingly, if they are not included in a special authorisation (licence) for the manufacturing of medicinal products.

- Types of products manufactured in the manufacturing plant (a list in Annex 2 to the description of the manufacturing plant), if they are not included in Annex 1 to the description of the manufacturing plant or Eudra GMDP database.

- Inspections of good manufacturing practice carried out in the manufacturing plant during the last five years, indicating dates, state and name of the competent authority which carried out the inspection. A reference to the certificate of good manufacturing practice issued by the State Agency of Medicines shall be included or a copy of the certificate of good manufacturing practice issued by the competent authority of another country shall be appended (in Annex 3 to the description of the manufacturing plant) or a reference to Eudra GMDP database, where available

1.3. Any manufacturing activities of other types performed in the manufacturing plant - Description of non-pharmaceutical activities carried out in the manufacturing plant, if any are carried out
2. QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER
2.1. Quality management system of the manufacturer - Short description of the quality management system used by the manufacturer and reference to the used standards.

- Duties in relation to maintaining the quality management system, including duties of the leading personnel.

- Information on activities for the performance of which the manufacturing plant is accredited and certified, including dates and content of accreditations, names of accreditation institutions

2.2. Output procedure of the finished products - A detailed description of the qualification requirements (education and work experience) for an authorised person(-s) responsible for certification and output procedures of batches - or a qualified person(-s).

- A general description of certification and output procedure of batches.

- The role of the responsible person or qualified person in the quarantine, output and conformity assessment of finished products, including for the registered medicinal products in conformity with the documentation submitted for their registration.

- Mutual co-operation measures between responsible persons and qualified persons, if several authorised or qualified persons are involved.

- Indication whether process analytical technology (PAT) and real time output or parametric output is used in the control strategy

2.3. Management of suppliers and contractors - Procedures by which supply ("supply chain") is conducted, as well as a short summary of the external audit programme.

- A short description of the qualification system of contractors, manufacturers of active substances (AS) and other suppliers of critical materials.

- Measures taken which ensure the conformity of the manufactured products with the requirements of the guidelines for transmissible spongiform encephalopathy (TSE).

- Measures to be taken if it is detected or there are suspicions that products, non-packed products (non-packed tablets), active substances or excipients are falsified.

- Scientific, analytical or technical assistance used outside the manufacturing plant and related to the manufacturing and analysis.

- A list of manufacturers and laboratories involved on a contractual basis, including addresses, contact information and supply chain flow scheme of manufacturing or quality control services provided on a contractual basis, for example, sterilisation of primary packaging of aseptic processes, testing of non-processed raw materials (to be included in Annex 4 to the description of the manufacturing plant).

- A short description regarding division of responsibility between the commissioning party and the performer of the contract in conformity with registration (registration certificate, documentation) (if not indicated in Sub-paragraph 2.2 of the description of the manufacturing plant)

2.4. Quality risk management - A short description of the quality risk management methodology used by the manufacturer.

- Quality risk management framework and main focus, including a short description of any activity that is performed in corporate level and that is performed locally. Indicate any use of the quality risk management system for assessment of the supply continuity.

2.5. Product quality assessment - A short description of the used methodology
3. Personnel
    - Organisational structure, indicating measures for the quality management system, manufacturing process and quality control positions (names) (Annex 5 to the description of the manufacturing plant), as well as leading personnel and qualified person.

- Number of employees involved in the quality management, manufacturing, quality control, storage and distribution accordingly

4. PREMISES AND EQUIPMENT
4.1. Premises - A short description of the manufacturing plant - its size, list of buildings. If products that are intended for different markets, for example, local market, European Union, USA market are manufactured in different buildings of the manufacturing plant, the buildings must be listed by indicating the intended market (if it is not identified in Sub-paragraph 1.1 of the description of the manufacturing plant).

- A simple plan or description of manufacturing areas, by indicating a scale (a technical drawing is not necessary).

- A plan of the manufacturing area(-s) and flow scheme (Annex 6 to the description of the manufacturing plant), indicating the classification of premises and difference of pressure between adjacent areas, as well as manufacturing activities to be carried out in the premises (for example, mixing, filling, storage, packaging).

- A plan of warehouses and storage areas, by indicating, where applicable, special areas where highly toxic, hazardous and sensitising materials are handled and where they are stored.

- A short description of specific storage conditions, where applicable, but not indicated in plans

4.1.1. A short description of the heating, ventilation and air conditioning (HVAC) system - Differences between air supply, temperature, humidity, pressure and principles for determination of air exchange speed, air re-circulation (%)
4.1.2. A short description of water systems - Quality indicators of the manufactured water.

- Schematic drawings of systems (Annex 7 to the description of the manufacturing plant)

4.1.3. A short description of other significant provisions, for example, steam, compressed air, nitrogen  
4.2. Equipment  
4.2.1. Annex 8 provides a list of the main equipment of the manufacturing and control laboratory, indicating the equipment  
4.2.2. Cleaning and disinfection measures - A short description of methods for cleaning and disinfection of product contact surfaces (for example, manual cleaning, automatic cleaning (Clean-in-Place))
4.2.3. Critical computerised systems of good manufacturing practice - A description of critical computerised systems of good manufacturing practice (except programmable logic controllers (PLC) of specific equipment)
5. DOCUMENTATION
    - A description of the documentation system (electronic, manual).

- If documents and minutes are stored or archived outside the manufacturing plant (including pharmacovigilance data, where applicable), the following shall be indicated:

a) types of documents and minutes,

b) name and address of the storage site, as well as approximate time necessary for delivery of documents from the archives outside the manufacturing plant

6. MANUFACTURING
6.1. Types of products May refer to Annex 1 or 2 of the description of the manufacturing plant:

- Types of manufactured products, including:

• a list of medicinal products for human use and veterinary pharmaceutical forms manufactured in the manufacturing plant;

• a list of any investigational pharmaceutical forms intended for clinical researches, manufactured in the manufacturing plant. Where different from commercial manufacturing, indicate information on the manufacturing areas and personnel.

- Toxic or hazardous substances (for example, with high pharmacologic activity and sensitising properties).

- Types of products that are manufactured in the premises specially allocated for that purpose or in the form of campaigns, where applicable.

- Application of process analytical technologies (PAT) if applicable: general outline of the corresponding technologies and the computerised systems related thereto

6.2. Process validation - A short description of the general procedure of process validation

- Repeated processing or processing policy

6.3. Management and placement of materials and storage in warehouses - Measures for the performance of activities involving raw materials, packaging materials, non-packed products and finished products, including sample taking, quarantine, output and storage.

- Measures for the performance of activities involving rejected materials and products

7. QUALITY CONTROL
    - A description of the quality control activities carried out in the manufacturing plant in respect of physical, chemical, microbiological and biological testing
8. DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALL
8.1. Distribution (in relation to the stage for which the manufacturer is responsible) - Types of firms (owners of wholesale trade licence, owners of manufacturing licence and others) and their locations (for example, European Union, European Economic Area, the USA) where the products are sent from the manufacturing plant.

- System description - how the inspection is carried out, whether each customer and recipient have legal right to receive medicinal products from the manufacturer, how appropriate environmental conditions are ensured during transportation (for example, supervision and control of temperature).

- Measures for the distribution of products and methods for the provision of product traceability.

- Measures that are carried out in order to prevent that products of the manufacturer enter illegal supply chain

8.2. Complaints, product defects and recall - Activities in case of complaints, product defects and recall of products - a short description of the system
9. SELF-INSPECTION
    - A short description of self-inspection system, paying attention to the criteria in conformity with which the fields that will be inspected in the planned inspections are selected, as well as to the practical procedures and further activities

Annex 1 A copy of valid special authorisation (licence) to manufacture medicinal products (if the licence is issued by the competent authority of another state).

Annex 2 List of the manufactured pharmaceutical forms, including international non-proprietary names of active substances or trade names (according to availability).

Annex 3 A copy of valid good manufacturing practice certificate (if the inspection is carried out by the competent authority of another state).

Annex 4 A list of manufacturers and laboratories involved on a contractual basis, including their addresses, contact information and supply chain flow schemes of activities carried out on a contractual basis.

Annex 5 Structures of the organisation.

Annex 6 Plan of the manufacturing areas, indicating material and personnel flows, general flow schemes for manufacturing processes of each product type (pharmaceutical form).

Annex 7 Schematic drawings of water system.

Annex 8 List of main manufacturing and laboratory equipment.

Person responsible for the description of the manufacturing plant

(position)

(given name, surname)

(signature)

Date ____________________

Notes.

1. The volume of a description of the manufacturing plant shall not exceed 25-30 A4 format pages (Annexes may be in addition thereto). Simple plans or schemes shall be used in the description (diagrams, graphic figures). When printing out the description of the manufacturing plant with Annexes on A4 format pages, it shall be legible.

2. The description of the manufacturing plant shall be drawn up so that each chapter and paragraphs thereof, which are indicated as "Requirements", is followed by "Instructions" (if any) accordingly, in which an explanation is provided regarding how the fulfilment of such requirements should be demonstrated.

3. The detail of the document "signature" shall not be completed if the document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

 

Annex 3
Cabinet Regulation No. 800
19 October 2011

[25 June 2013]

Medicinal Products, Veterinary Medicinal Products or Controlled Substances* Manufactured for Export

1. Medicinal products or veterinary medicinal products manufactured for export

Firm name or performer of economic activity, manufacturing plant name
Manufacturing site address
 

No.

Name of the medicinal product

International name (INN)

Strength (dose)

Pharmaceutical form

Narcotic medicinal product

Psychotropic medicinal product

Only packaging (primary, secondary)

Registration number in the Medicinal Product Register of Latvia

Manufactured only for export

1

2

3

4

5

6

7

8

9

10

                   
                   
                   
                   
                   

Given name, surname, position of the person submitting the information
Date Signature

2. Controlled substances*

 

Firm name or performer of economic activity, for a manufacturer - name of the manufacturing plant
Address of the manufacturing site, for an importer - address of the importing site
 

No.

Name of the substance

International name (INN) or, if none, chemical name and substance registration number CAS

Active substance content

Narcotic substance

Psychotropic substance

Only packaging or labelling

Name of the manufacturer, address of the manufacturing plant, country

Manufactured only for export

1

2

3

4

5

6

7

8

9

                 
                 
                 
Given name, surname, position of the person submitting the information
Date Signature

Notes.

1. * Substances included in the lists II and III of narcotic and psychotropic substances to be controlled in Latvia.

2. All strengths (doses) shall be indicated for one name and form of the medicinal product.

3. Mark the appropriate box with an "x".

4. Lists shall be submitted electronically - separately for medicinal products for human use and veterinary medicinal products.

5. The detail of the document "signature" shall not be completed if the document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

Minister for Health J. Bārzdiņš

 

Annex 4
Cabinet Regulation No. 800
19 October 2011

[25 June 2013; 16 December 2014]

Submission for Conformity Assessment and Issuance or Re-registration of a Special Authorisation (Licence) to Open (Operate) a Medicinal Product Wholesaler

To the State Agency of Medicines

1. Information on the submitter:

1.1. firm name or given name, surname and personal identity number of the performer of economic activity
1.2. name of the medicinal product wholesaler
1.3. address, postal code of the site of the pharmaceutical activity
1.4. number of the licence to open (operate) a medicinal product wholesaler (if any)
1.5. telephone
1.6. fax
1.7. e-mail address (if any)
1.8. website
1.9. legal address of the merchant and office address thereof, if different from the legal address (for a branch of a foreign merchant - also legal address of the foreign merchant), but for the performer of economic activity - address of the declared place of residence
1.10. registration number in the Commercial Register (shall not apply to the performer of economic activity)

2. I request (mark as appropriate with an "x"):

2.1. to perform conformity assessment

2.2. to issue a special authorisation (licence) to open (operate) a medicinal product wholesaler

2.3. to re-register a special authorisation (licence) due to:

2.3.1. the change of the name of the holder of the special authorisation (licence)

2.3.2. the change of legal address of the holder of the special authorisation (licence)

2.3.3. the change of the site of the pharmaceutical activity

2.3.4. the change of the responsible official

2.3.5. the commencement of a new type of a special activity

2.3.6. the commencement of operation of a new division

2.3.7. other reasons (indicate what) ______________________________________

3. Information on the responsible officials:

3.1. the official responsible for distribution of medicinal products:
3.1.1. given name, surname
3.1.2. personal identity number
3.1.3. position
3.1.4. telephone
3.1.5. fax
3.1.6. e-mail address
3.2. the official responsible for distribution of veterinary medicinal products:
3.2.1. given name, surname
3.2.2. personal identity number
3.2.3. position
3.2.4. telephone
3.2.5. fax
3.2.6. e-mail address
3.3. the official responsible for fulfilling the commitments of public services:
3.3.1. given name, surname
3.3.2. personal identity number
3.3.3. position
3.3.4. telephone
3.3.5. fax
3.3.6. e-mail address
3.4. the official responsible for distribution of narcotic or psychotropic substances and medicinal products:
3.4.1. given name, surname
3.4.2. personal identity number
3.4.3. position
3.4.4. telephone
3.4.5. fax
3.4.6. e-mail address
3.5. the official responsible for trade in spirits:
3.5.1. given name, surname
3.5.2. personal identity number
3.5.3. position
3.5.4. telephone
3.5.5. fax
3.5.6. e-mail address

Note. If there are several responsible persons, the abovementioned information shall be indicated regarding each person.

4. Information on the branch or department of a medicinal product wholesaler (if any):

4.1. name
4.2. address
4.3. given name, surname of the responsible official
4.4. personal identity number
4.5. telephone
4.6. fax
4.7. e-mail address (if any)
4.8. website (if different from the website of the wholesaler)

Note. Information on other branches or departments of the medicinal product wholesaler (if any) shall be indicated on a separate sheet of paper and appended to the submission.

5. Information on the types of the special activity (mark as appropriate with an "x"):

5.1. distribution of psychotropic medicinal products

5.2. distribution of psychotropic substances

5.3. distribution of narcotic medicinal products and of psychotropic medicinal products considered as equivalent thereto

5.4. distribution of narcotic substances and of psychotropic substances considered as equivalent thereto

5.5. distribution of veterinary medicinal products

5.6. distribution of such veterinary medicinal products which contain substances with anabolic, anti-infectious, antiparasitic, anti-inflammatory and hormonal properties (mark as appropriate with an "x"):

5.6.1. antimicrobials, also sulphanilamides and quinolones

5.6.2. anthelmintic substances

5.6.3. coccidiostatic substances, also nitroimidazoles

5.6.4. carbamates and pyrethroids

5.6.5. sedatives

5.6.6. non-steroidal anti-inflammatory substances

5.6.7. other pharmacologically active substances and medicinal products which are not included in the register of veterinary medicinal products, but which could be used in medical treatment of animals

5.7. distribution of spirits

5.8. distribution of immunological preparations

5.9. distribution of blood products

5.10. distribution of cold chain products (which require storage in low temperature)

5.11. distribution of radiopharmaceutical preparations (including radionuclide sets)

5.12. distribution of medical gas

6. Additional information (mark as appropriate with an "x"):

6.1. storage of medicinal products owned by a foreign manufacturer of medicinal products according to the contract (which are distributed by authorised representatives of a foreign manufacturer of medicinal products to medicinal product wholesalers)

6.2. acceptance of medicinal product orders is ensured all twenty-four hours a day (24 hours).

Indicate contact information:

6.2.1. telephone
6.2.2. fax
6.2.3. e-mail address (if any)

6.3. distribution of parallel imported medicinal products

6.4. parallel distribution of medicinal products registered according to centralised procedure

6.5. distributes medicinal products:

6.5.1. which are registered in EEA (European Economic Area) country (countries) (also applies to medicinal products to which an authorisation has been granted for the distribution of medicinal products registered in a EEA country, but not registered in the Republic of Latvia)

6.5.2. which are not registered in the EEA and are provided for the EEA market

6.5.3. which are not registered in the EEA and are provided for exportation

[Sub-paragraphs 6.6-6.9 shall be deleted from 16 December 2014]

6.10. wholesale activities involving medicinal products to be registered:

6.10.1. purchase

6.10.2. storage

6.10.3. supply (supplying of medicinal products in Latvia or another EEA country)

6.10.4. exportation (bringing out of medicinal products to third countries)

6.10.5. other activities (to be indicated) __________________________________

6.11. information regarding a contract with the medicinal product wholesaler (if any):

6.11.1. name and licence number of the medicinal product wholesaler ________________

6.11.2. address of the site of pharmaceutical activity

7. Information on equipment and devices of the wholesaler (mark as appropriate with an "x"):

7.1. premises and devices ensure the regime of temperature necessary for the storage of medicinal products:

7.1.1. in the room temperature (from 15 °C to 25 °C)

7.1.2. in a cool place (from 8 °C to 15 °C)

7.1.3. in a cold place (from 2 °C to 8 °C)

7.2. other devices and equipment:

7.2.1. computer (indicate the number) _____

7.2.2. computer programmes (indicate the type of computer programmes) _____________

7.2.3. Internet connectivity

7.2.4. elevator (indicate the number) _____

7.2.5. premises of the medicinal product wholesaler are provided with an individual technical security system

7.2.6. premises of the medicinal product wholesaler are provided with a security system connected to the central security system

7.2.7. the place for storage of narcotic medicinal products and substances is provided with a sound or light alarm

7.2.8. having of a fax

7.2.9. cooler bags or containers (number)

8. Information on the working hours of a wholesaler (time of beginning and end of work shall be indicated):

Monday  
Tuesday  
Wednesday  
Thursday  
Friday  
Saturday  
Sunday  

9. The following documents are appended to the submission (mark as appropriate with an x):

9.1. a simple plan of premises of a medicinal product wholesaler (an architectural design or technical drawings are not required) and a description of the activity to be carried out therein. Rooms shall be numbered on the plan and an itemised list of the relevant numbering shall be appended. The plan shall be comprehensible and outlined on an A4 format sheet. Where appropriate, the plan may also be arranged on an A3 format sheet. The description shall be made in the form of a narration.

9.2. a document attesting the right of the submitter to use the premises for the intended pharmaceutical activity (a document attesting property rights or a lease contract) (a certified copy) on ______pages

9.3. a document attesting the conformity of the premises with the construction requirements (a deed on putting into service of the structure) (a certified copy) on ______pages

9.4. a statement on employment legal relationships of the employer and the officials referred to in Paragraphs 3 and 4 of this submission, duration thereof, work performed by an employee, on ________ pages

9.5. a document regarding assigning of responsible officials of the wholesaler attesting the appointing of the persons to the relevant position (a certified copy), on ______pages

9.6. a document regarding assigning of responsible officials for ensuring of the types of a special activity (a certified copy) on ______pages

9.7. a document certifying education of the persons referred to in Paragraphs 3 and 4 of this submission (a certified copy) and CV, on ______ pages

9.8. a written attestation of the submitter that the founders thereof (to be listed) and members (to be listed) comply with the requirements of Section 11, Clause 2 of the law On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, on _________ pages

9.9. a written attestation of the official responsible for trade in narcotic or psychotropic substances and medicinal products that a person complies with the requirements of Section 11, Clauses 1 and 3 of the law On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, on _______ pages

9.10. written information on ensuring of good distribution practices of medicinal products where the developed written procedures are listed according to the assortment and activities carried out of the wholesaler, as well as types of special activity, on ___________ pages

9.11. a plan for emergency situations in order to ensure efficient recall of medicinal products from the market (a certified copy), on ____ pages

9.12. a receipt regarding payment of the State fee

9.13. other additional information on ______ pages

9.14. a document by which the merchant or performer of economic activity authorises the person referred to in Paragraph 10 of this submission to submit a submission and documents to the State Agency of Medicines, on _______ pages

10. I hereby attest that the information provided in the submission, the documents appended to the submission and other information is complete and true, and it conforms to the requirements laid down in the Cabinet Regulation No. 800 of 19 October 2011, Procedures for the Licensing of Pharmaceutical Activity:

10.1. given name and surname
10.2. position
10.3. address
10.4. telephone, fax, e-mail
 

(place, date)

 

(signature)

(signature of the person with the right of representation)

Note. The detail of the document "signature" shall not be completed if the document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

Minister for Health J. Bārzdiņš

 

Annex 5
Cabinet Regulation No. 800
19 October 2011

[25 June 2013; 26 January 2016 / Sub-paragraphs 7.6, 16.7.1,
and 16.11.1 shall come into force on 1 March 2016. See Paragraph 2 of amendments]

Submission Regarding Issuing or Re-registering of a Special Authorisation (Licence) to Open (Operate) a Pharmacy, or Regarding Changes in the Submitted Information and Documents

To the State Agency of Medicines

1. Information on the submitter:

1.1. company
1.2. given name, surname and personal identity number of the performer of economic activity
1.3. registration number in the Commercial Register (shall not apply to the performer of economic activity)
1.4. legal address of the merchant, for a performer of economic activity - address of the declared place of residence
1.5. name of the pharmacy
1.6. address, postal code of the site of the pharmaceutical activity
1.7. number of the licence to open (operate) a pharmacy (if any)
1.8. telephone
1.9. fax
1.10. e-mail address (if any)
1.11. bank details

2. Information on the local government or medical treatment institution which has established a pharmacy (the applicant for the opening (operation) of a local government general-type pharmacy or for the opening (operation) of a closed-type pharmacy, or a pharmacy of a medical treatment institution shall be indicated):

2.1. local governments or medical treatment institution, address
2.2. telephone
2.3. fax
2.4. e-mail address (if any)

3. I request (mark as appropriate with an "x"):

3.1. to issue a special authorisation (licence) to open (operate) a general-type pharmacy:

3.1.1. for a pharmacist practice or assistant pharmacist practice;

3.1.2. for a pharmacist collective practice or assistant pharmacist collective practice;

3.1.3. for a capital company

3.1.4. for a local government

3.2. to issue a special authorisation (licence) to open (operate) a closed-type pharmacy or a pharmacy of a medical treatment institution

3.3. to re-register a special authorisation (licence) due to:

3.3.1. the change of the name of the holder of the special authorisation (licence)

3.3.2. the change of legal address of the holder of the special authorisation (licence)

3.3.3. the change of the site of the pharmaceutical activity

3.3.4. the commencement of a new type of a special activity

3.3.5. the change of the manager of the pharmacy

3.3.6. the opening of a new branch of the pharmacy

3.3.7. other reasons (indicate what) ______________________________________

3.4. to make changes in the information submitted in relation to a special authorisation (licence) matter

4. Information on pharmaceutical activity (mark as appropriate with an "x"):

4.1. distributes medicinal products to medical treatment institutions

4.2. distributes medicinal products to social care institutions

4.3. distributes veterinary medicinal products

4.4. acquires purified water

4.5. provides additional services (indicate them) _______________________________

4.6. arrange a register of regular visitors of the pharmacy (indicate the number of patients included in the register) _____________________________

4.7. ensure issuing of non-registered medicinal products in return for prescriptions of a doctor and requests of medical treatment institutions

5. Information on the responsible officials:

5.1. manager of the pharmacy:  
5.1.1. given name, surname
5.1.2. personal identity number
5.1.3. qualification
5.1.4. registration number in the register of the Latvian Pharmacist Association and certificate number
5.2. deputy manager of the pharmacy or the pharmacist who substitutes the manager of the pharmacy:
5.1.2. given name, surname
5.2.2. personal identity number
5.2.3. registration number in the register of the Latvian Pharmacist Association and certificate number
5.2.4. qualification

6. Information on the branch of a pharmacy (if any):

6.1. name of the branch of the pharmacy
6.2. address
6.3. telephone
6.4. fax number
6.5. e-mail address (if any)
6.6. manager of the branch of the pharmacy:
6.6.1. given name, surname
6.6.2. personal identity number
6.6.3. registration number in the register of the Latvian Pharmacist Association
6.6.4. qualification

Note. If the pharmacy has several branches, the abovementioned information shall be indicated separately for each branch.

7. Information on the conditions of the special activity (mark as appropriate with an "x"):

7.1. distribution of psychotropic medicinal products

The official responsible for distribution of psychotropic medicinal products:

7.1.1. given name, surname
7.1.2. personal identity number
7.1.3. registration number in the register of the Latvian Pharmacist Association
7.1.4. qualification

7.2. distribution of narcotic medicinal products and of psychotropic medicinal products considered as equivalent thereto

The official responsible for distribution of narcotic medicinal products and psychotropic medicinal products considered as equivalent thereto:

7.2.1. given name, surname
7.2.2. personal identity number
7.2.3. registration number in the register of the Latvian Pharmacist Association
7.2.4. qualification

7.3. preparation of medicinal products in a pharmacy

The official responsible for preparation of medicinal products in a pharmacy:

7.3.1. given name, surname
7.3.2. registration number in the register of the Latvian Pharmacist Association
7.3.3. qualification

7.4. distribution of veterinary medicinal products

The official responsible for distribution of veterinary medicinal products:

7.4.1. given name, surname
7.4.2. number of the certificate issued by the Latvian Association of Veterinarians
7.4.3. qualification

7.5. distribution of non-prescription medicinal products, using website:

7.5.1. domain name and e-mail address
7.5.2. given name, surname of the responsible official
7.5.3. registration number in the register of the Latvian Pharmacist Association and certificate number
7.5.4. qualification
7.5.5. telephone number (operates twenty-four-hours) for the receipt of information

7.6. distribution of non-prescription veterinary medicinal products, using website:

7.6.1. domain name and e-mail address
7.6.2. given name, surname of the designated person
7.6.3. number of the certificate issued by the Latvian Association of Veterinarians
7.6.4. qualification
7.6.5. telephone number (operates twenty-four-hours) for the receipt of information

7.7. open day-and-night

8. Information on premises and arrangement of the pharmacy (branch of the pharmacy) (mark as appropriate with an "x"):

8.1. information regarding the pharmacy

8.1.1. the pharmacy or branch of the pharmacy is located on the ______ floor of the building

8.1.2. the customer servicing area of the pharmacy (branch of the pharmacy) is located on the _______ floor of the building

8.1.3. customers entrance is equipped with an air lock

8.1.4. the entrance (exit) in a general-type pharmacy and branch of a pharmacy intended for customers in a customer servicing area is without a doorstep and suitable for entering with a wheelchair and baby stroller

yes

no

If the answer is "no", indicate in what way entrance (exit) and free movement of disabled persons and customers with baby strollers are ensured in the pharmacy (for example, the pharmacy is located in a building or structure, in a part thereof or group of premises where the accessibility of the environment is ensured by alternative technical solutions - a bell is arranged at the entrance and it is in working order, the bell button can be reached also by a person who uses a wheelchair), or indicate a specific deadline when this requirement will be ensured.

If the customer servicing area of a pharmacy or branch of a pharmacy is not located on the first floor, indicate in what way customers in wheelchairs and with baby strollers are ensured the possibility to get to the relevant floor where the customer servicing area of the pharmacy is located.

8.1.5. uniformity of the premises of the pharmacy is ensured

9. Information on the official who is responsible for ensuring the conditions for storage of medicinal products and conformity with the instructions:

9.1. given name, surname of the official
9.2. registration number in the register of the Latvian Pharmacist Association
9.3. qualification

10. Information on ensuring the temperature required for the storage of medicinal products:

No.

Necessary temperature

Premises in which the relevant temperature is ensured, or equipment which is used for ensuring the relevant temperature

10.1. room temperature (from 15 to 25°C)  
10.2. cool place (from 8 to 15°C)  
10.3. cold place (from 2 to 8°C)  

11. Storage of medicinal products and other goods to be stored under special conditions

No.

Medicinal products which require special storage conditions

Premises and equipment for storage of the relevant medical products and other goods

11.1. storage of narcotic medicinal products and substances  
11.2. storage of psychotropic medicinal products and substances  

12. Information on the devices and equipment (mark as appropriate with an "x"):

12.1. computer (indicate the number) _____________

12.2. computer programmes (indicate the type of computer programmes) ____________

12.3. Internet connectivity

12.4. elevator (indicate the number) _________________

12.5. premises of the pharmacy (branch of the pharmacy) are provided with an individual technical security system

12.6. premises of the pharmacy (branch of the pharmacy) are provided with a security system connected to the central security system

12.7. the place for storage of narcotic medicinal products and substances is provided with a sound or light alarm

13. Information on co-operation with other undertakings and institutions:

13.1. contract with the National Health Service regarding distribution of medicinal products included in the compensation system for purchase of medicinal products

13.2. a contract with an undertaking of pharmaceutical activity on supply of the medicinal products prepared in the pharmacy, if medicinal products are not prepared in the pharmacy (indicate the name and address of the undertaking of pharmaceutical activity)____________________________

13.3. a contract with insurance companies (indicate the name of the insurance company)

13.4. professional training of employees is organised (indicate the number of employees involved in training and the type of training) _____________________________________________________

14. Working hours of the pharmacy (branch of the pharmacy):

14.1. [26 January 2016]

14.2. servicing of inhabitants is ensured during working hours (the time of the beginning and end of work shall be indicated)

Monday  
Tuesday  
Wednesday  
Thursday  
Friday  
Saturday  
Sunday  

Note. Closed-type pharmacies need not comply with this condition.

15. Division of working hours of the manager of the pharmacy (branch of the pharmacy) and the deputy manager of the pharmacy (branch of the pharmacy) or pharmacist who substitutes the manager of the pharmacy

Day

Working hours of the manager of the pharmacy (branch of the pharmacy)

Working hours of the deputy manager of the pharmacy (branch of the pharmacy) or pharmacist who substitutes the manager of the pharmacy (branch of the pharmacy)

from

to

from

to

Monday        
Tuesday        
Wednesday        
Thursday        
Friday        
Saturday        
Sunday        

16. The following documents are appended to the submission (mark as appropriate with an x):

16.1. attestation:

16.1.1. the premises, technical equipment and devices (including control devices), documentation and personnel referred to in Sub-paragraphs 30.1 and 30.2 of Cabinet Regulation No. 800 of 19 October 2011, Procedures for the Licensing of Pharmaceutical Activity, are at the disposal of the person to be licensed:

attests that:

(firm name or given name and surname of the performer of economic activity)

 
in the pharmacy
 

(name and address)

in the branch of the pharmacy
 

(address)

there are suitable and proper premises, technical equipment and devices, including control devices. The documentation and personnel comply with the requirements laid down in the Pharmaceutical Law and the laws and regulations regarding opening and operation of pharmacies, distribution of medicinal products and veterinary medicinal products and in other laws and regulations governing pharmacy.

 

(place, date)

 

(signature)

If any of the requirements laid down in the laws and regulations cannot be conformed to, the reason shall be explained:

16.1.2. if it is intended to use controlled substances for the preparation of medicinal products, as well as to distribute narcotic medicinal products and psychotropic medicinal products:

_____________________________________________ attests that the following is ensured:
(firm name or given name and surname of the performer of economic activity)

trade in narcotic medicinal products

trade in psychotropic medicinal products

trade in narcotic substances

trade in psychotropic substances

in accordance with the laws and regulations regarding trade in narcotic and psychotropic medicinal products and substances, as well as the requirements laid down in the laws and regulations governing pharmacy or veterinary pharmacy, and at least one official responsible for trade in narcotic and psychotropic medicinal products and substances is at the disposal of the submitter.

 

(place, date)

 

(signature)

If any of the requirements laid down in the laws and regulations cannot be conformed to, the reason shall be explained:

16.2. the attestations referred to in Sub-paragraph 16.1 of this Annex shall be provided by a delegated representative of the licence holder who is responsible for the operation of the undertaking of pharmaceutical activity in accordance with the requirements of laws and regulations;

16.3. a simple plan of premises of the pharmacy (branch of the pharmacy) (an architectural design or technical drawings are not required) and a description of the activities to be carried out therein (approved by the signature of the manager of the pharmacy). The name of the pharmacy (branch of the pharmacy), address shall be indicated on the plan, the rooms shall be numbered and a list of the relevant numbering shall be appended. The plan shall be comprehensible and outlined on an A4 format sheet. Where appropriate, the plan may also be arranged on an A3 format sheet. The description shall be made in the form of a narration. Only the most important (critical) premises which include all premises for the preparation of medicinal products, as well as the main premises for storage of medicinal products, shall be described in detail. The plan of premises shall demonstrate clearly and plainly the area of the room or separated place where the following is located:

16.3.1. the customer servicing area (the place is marked where customers may be present and where rest area for customers is arranged (in general-type pharmacies and branches of the pharmacy)). The dimension of the customer servicing area where customers may be present shall be indicated (at least 10 square metres);

16.3.2. the area (room) for storage of medicinal products and goods and the area for storage of goods in the customer servicing area;

16.3.3. the area for storage of products recalled from stocks of medicinal products - the room for receipt of goods with a separate quarantine zone - the area which is provided for placement of incorrectly delivered goods or goods of questionable quality until they are returned to the supplier, for quality certification of goods or for receipt of the necessary accompanying documents;

16.3.4. the defective area for placement of goods of poor quality, including area for storage of falsified medicinal products;

16.3.5. the area for receipt and dispensation of medicinal products and goods. The room for receipt of requests from a medical treatment institution and the issue of orders (in closed-type pharmacies);

16.3.6. the room or rooms for preparation of medicinal products (if medicinal products are prepared or packaged in the pharmacy);

16.3.7. separate rooms or partitioned areas in other rooms (except the customer servicing area, the room for storage of goods or the zone for storage of goods and the rooms for preparation of medicinal products):

16.3.7.1. wardrobe for employees;

16.3.7.2. the area for storage of inventory for cleaning of premises;

16.3.8. toilet with a sink for employees (if necessary);

16.3.9. administrative room (in pharmacies operating in towns)

16.4. information on the lease contract indicating a definite time period for which it is entered into, between whom it has been entered into and when it enters into effect, as well as the correct address of the premises referred to in the lease contract. If the premises are owned by the submitter, a notation as to which document certifies it (for example, a Land Register certificate ) on _____pages

16.5. a written statement issued by the employer regarding employment legal relationships of the employer and the manager of the pharmacy, deputy manager of the pharmacy (if any), managers of the branches of the pharmacy, duration thereof, work performed by the employee, as well as the document (copy) approved by the manager of the undertaking confirming the appointing of the person to the relevant position, on ____ pages

16.6. an order of the employer (certified copy) by which an official responsible for the ensuring of the conditions of a special activity is appointed, on ____ pages

16.7. a list of persons employed in the pharmacy (branch of the pharmacy) having pharmaceutical education (given name, surname, qualification, registration number in the Latvian Pharmacist Association), which has been approved by the employer, on ____ pages

16.7.1 a list of persons employed in the pharmacy (branch of the pharmacy) to whom a certificate of the Latvian Association of Veterinarians has been issued (given name, surname, qualification, number of the certificate of the Latvian Association of Veterinarians), on ____ pages (to be submitted if veterinary medicinal products are distributed in the pharmacy)

16.8. a document (copy) attesting that a pharmacist is the founder of the pharmacy (if an individual merchant has established a general-type pharmacy), on ___ pages

16.9. documents (copies) confirming that all the founders are pharmacists (for a general-type pharmacy, which has been established as the collective practice of pharmacists), on ____ pages

16.10. a contract entered by and between the local government and the pharmacist regarding the provision of pharmaceutical care in the pharmacy (if the local government has established a general-type pharmacy) on ___ pages

16.11. instructions signed by the manager of the pharmacy regarding distribution of medicinal products on the Internet where the responsible official is also indicated, on ____ pages

16.11.1 procedures approved by the manager of the pharmacy regarding distribution of veterinary medicinal products on the Internet where the responsible official is also indicated, on ____ pages (to be submitted if non-prescription veterinary medicinal products are distributed in the pharmacy, using website)

16.12. a contract of the pharmacy, which does not prepare medicinal products, regarding preparation of medicinal products with the pharmacy which carries out preparation of medicinal products (a copy), on ____ pages

16.13. a receipt regarding payment of the State fee

16.14. other additional information on ____ pages

16.15. a document by which the merchant or performer of economic activity authorises a person to submit a submission and documents to the State Agency of Medicines, on ____ pages

17. I hereby inform that the manager of the pharmacy and the deputy manager of the pharmacy (a merchant or persons involved in the executive body of the merchant) during the year before submitting the application:

has been punished for infringements in relation to the pharmaceutical activity, as well as his or her criminal record has not been removed or cleared in accordance with laws and regulations

has not been punished for infringements in relation to the pharmaceutical activity or his or her criminal record has been removed or cleared in accordance with laws and regulations

18. I attest that the applied site (premises) of the activity:

has been put into service

has not been put into service

19. I hereby attest that the information provided in the submission, the documents appended to the submission and other information is complete and true, and it conforms to the requirements laid down in the Cabinet Regulation No. 800 of 19 October 2011, Procedures for the Licensing of Pharmaceutical Activity:

19.1. given name and surname
19.2. position
19.3. address
19.4. telephone, fax, e-mail

 

(place, date)

 

(signature)

   

(signature of the person with the right of representation)

Note. The detail of the document "signature" shall not be completed if the document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

Minister for Health J. Bārzdiņš

 

Annex 6
Cabinet Regulation No. 800
19 October 2011

[25 June 2013]

Special Authorisation (Licence)

(the type of the special authorisation (licence))

Republic of Latvia
State Agency of Medicines

(address, registration number, telephone and fax number)

Rīga

Licence No._______________

Firm name or performer of economic activity

(firm name (for a performer of economic activity - given name and surname) and name of the site of pharmaceutical activity, if they are different, for a merchant registration number and type of the merchant)

Legal address of the merchant (for a performer of economic activity - address of the declared place of residence)
Address(es) of the site of pharmaceutical activity

(for a pharmacy - addresses of the branch of the pharmacy, for a medicinal product wholesaler - addresses of the department of a medicinal product wholesaler, if any)

Responsible official or the manager of the pharmacy

(given name and surname of the manager of the pharmacy, responsible official of the medicinal product wholesaler)

Date and place of taking the decision to issue (re-register) the licence, and the number of the decision
Licence valid until
Director of the State Agency of Medicines  
 

(given name, surname)

 

(signature)

Date _________________

Annexes to the licence and the number of pages of annexes

Note. The detail of the document "signature" shall not be completed if the document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

Minister for Health J. Bārzdiņš

 

Annex 6.1
Cabinet Regulation No. 800
19 October 2011

[25 June 2013; 16 December 2014]

LATVIJAS REPUBLIKA
ZĀĻU VALSTS AĢENTŪRA

 

REPUBLIC OF LATVIA
STATE AGENCY OF MEDICINES

 
 

(adrese, reģistrācijas numurs, tālruņa numurs,faksa numurs, e-pasta adrese)

 

(address, registration number, phone number,fax number, e-mail)

SPECIĀLA ATĻAUJA (LICENCE) CILVĒKIEM PAREDZĒTO ZĀĻU IZPLATĪŠANAI VAIRUMTIRDZNIECĪBĀ

AUTHORISATION FOR WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS FOR HUMAN USE

1. Speciālās atļaujas (licences) numurs
Number of authorisation
2. Speciālās atļaujas (licences) īpašnieka komersanta firma vai saimnieciskās darbības veicēja nosaukums
Firm of authorisation holder
3. Speciālās atļaujas (licences) īpašnieka juridiskā adrese
Legally registered address of authorisation holder
4. Farmaceitiskās darbības vietas(-u) adrese(-es)
Address(es) of site(s)

(norāda visu reģistrēto farmaceitiskās darbības vietu adreses)
(Addresses of all sites should be listed if not covered by separate authorisations)

5. Speciālās atļaujas (licences) joma (aizpildīt attiecībā uz katru 4.punktā minēto farmaceitiskās darbības vietu)
Scope of authorisation (complete for each site under paragraph 4)
6. Speciālās atļaujas (licences) izsniegšanas juridiskais pamatojums
Legal basis for authorisation
7. Zāļu valsts aģentūras atbildīgā amatpersona
Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

(vārds, uzvārds)

 
8. Paraksts  
Signature  
9. Datums  
Date  

Speciālai atļaujai (licencei) pievienotie pielikumi:

1. pielikums. Speciālās atļaujas (licences) darbības joma zāļu izplatīšanai vairumtirdzniecībā
Annex 1. Scope of Wholesaler Distribution Authorisation (Licence)

Farmaceitiskās darbības vietas nosaukums un adrese _____________________________
Name and address of the site

(Darbības jomu atzīmē ar X)
(Scope notes with X)

1. ZĀLES
MEDICINAL PRODUCTS

1.1. kuras ir reģistrētas EEZ (Eiropas Ekonomikas zonas) valstī(-īs)
with a Marketing Authorisation in the EEA (European Economic Area) country (ies)

1.2. kuras nav reģistrētas EEZ un paredzētas EEZ tirgum*
without a Marketing Authorisation in the EEA and intended for EEA market
*

1.3. kuras nav reģistrētas EEZ un paredzētas eksportēšanai
without a Marketing Authorisation in the EEA and intended for exportation

2. REĢISTRĒTĀS ZĀĻU VAIRUMTIRDZNIECĪBAS DARBĪBAS
AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. iegāde
Procurement

2.2. glabāšana
Holding

2.3. piegāde
Supply

2.4. eksportēšana
Export

2.5. citas darbības (norādīt)
other activities: (please specify)

3. Atļautie speciālās darbības nosacījumi - ZĀLES, UZ KURĀM ATTIECAS PAPILDU PRASĪBAS
authorized special operating conditions - MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. direktīvas 2001/83/EK 83. pantā noteiktās zāles
medicinal products according to Art. 83 of 2001/83/EC

3.1.1. narkotiskās un tām pielīdzinātās psihotropās zāles vai vielas vai psihotropās zāles vai vielas:
narcotic and equivalent thereto psychotropic medicinal products or substances or psychotropic medicinal products or substances:

3.1.1.1. psihotropās zāles
psychotropic medicinal products

3.1.1.2. psihotropās vielas
psychotropic substances

3.1.1.3. narkotiskās un tām pielīdzinātās psihotropās zāles
narcotic and equivalent thereto psychotropic medicinal products

3.1.1.4. narkotiskās un tām pielīdzinātās psihotropās vielas
narcotic and equivalent thereto psychotropic substances

3.1.2. no cilvēka asinīm un plazmas iegūtās zāles
medicinal products derived from human blood and plasma

3.1.3. imunoloģiskie preparāti
immunological medicinal products

3.1.4. radiofarmaceitiskie preparāti (tai skaitā radionuklīdu komplekti)
radiopharmaceuticals (including radionuclide kits)

3.2. medicīniskās gāzes
medicinal gases

3.3. aukstuma ķēdes produkti (nepieciešama uzglabāšana zemā temperatūrā)
cold chain products (requiring low temperature handling)

3.4. citi produkti
other products

3.4.1. veterinārās zāles
veterinary medicinal products

3.4.2. spirts
alcohol

Jebkuri ierobežojumi vai paskaidrojošas piezīmes par šīm zāļu vairumtirdzniecības darbībām
Any restrictions or clarifying remarks related to the scope of these wholesaling operations

 

* Direktīvas 2001/83/EK 5. pants vai Regulas EK 726/2004 83. pants (nereģistrētas zāles)
*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/ 726/2004

2.pielikums. Līgumdarbības zāļu lietirgotavu adrese(-s) un to speciālu atļauju (licenču) numuri.
3.pielikums. Atbildīgās(-o) personas(-u) vārds(-i), uzvārds(-i).
4.pielikums. Datums, kad veikta inspekcija, kas ir par pamatu speciālās atļaujas (licences) izsniegšanai.
Annexes attached:
Annex 2. Address(es) of Contract Wholesale Distribution Sites and their Authorisation Number
Annex 3. Name of Responsible Person
Annex 4. Date of Inspection on which Authorisation was Granted.

Notes.

1. The detail of the document "signature" shall not be completed if the document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

2. The authorised conditions of a special activity shall be indicated in Annex 1:

2.1. distribution of psychotropic medicinal products;

2.2. distribution of psychotropic substances;

2.3. distribution of narcotic medicinal products and of psychotropic medicinal products considered as equivalent thereto;

2.4. distribution of narcotic substances and of psychotropic substances considered as equivalent thereto;

2.5. distribution of spirits;

2.6. distribution of veterinary medicinal products

2.7. distribution of such veterinary medicinal products, which contain substances with anabolic, anti-infectious, antiparasitic, anti-inflammatory and hormonal properties, indicating separately:

2.7.1. antimicrobials, also sulphanilamides and quinolones;

2.7.2. anthelmintic substances

2.7.3. coccidiostatic substances, also nitroimidazoles;

2.7.4. carbamates and pyrethroids;

2.7.5. sedatives;

2.7.6. non-steroidal anti-inflammatory substances;

2.7.7. other pharmacologically active substances and medicinal products, which are not included in the register of veterinary medicinal products, but which could be used in medical treatment of animals.

3. [16 December 2014]

4. The official responsible for conformity with the good distribution practice of medicinal products shall be indicated in Annex 3 to the licence.

 

Annex 7
Cabinet Regulation No. 800
19 October 2011

[25 June 2013]

LATVIJAS REPUBLIKAZĀĻU VALSTS AĢENTŪRA

 

REPUBLIC OF LATVIASTATE AGENCY OF MEDICINES

 
 

(adrese, reģistrācijas numurs, tālruņa numurs,faksa numurs, e-pasta adrese)

 

(address, registration number, phone number,fax number, e-mail)

SPECIĀLĀ ATĻAUJA (LICENCE) ZĀĻU RAŽOŠANAI VAI IMPORTĒŠANAI

AUTHORISATION (LICENCE) FOR MEDICINAL PRODUCTS' MANUFACTURING OR IMPORTING

1. Speciālās atļaujas (licences) sērija, numurs  
Serial number, number of authorisation (licence)
2. Speciālās atļaujas (licences) īpašnieka firma, reģistrācijas numurs komercreģistrā
Name, registration number of authorisation (licence) holder
3. Farmaceitiskās darbības vietas(-u) (ražošanas vietas) adrese(-es)
Addresses authorised sites should be listed if not covered by a separate licence

(norāda visas licencētās vietas)

4. Speciālās atļaujas (licences) īpašnieka juridiskā adrese
Legally registered address of authorisation (licence) holder
5. Speciālās atļaujas (licences) darbības joma un zāļu formas - šīs speciālās atļaujas (licences) pielikuma 1. vai 2.pielikumā (dažādām ražotnēm aizpilda atsevišķu pielikumu, ja par tām nav izsniegta atsevišķa licence)
Scope of authorisation (licence) and dosage forms (ANNEX 1 or ANNEX 2) (separate Annexes for different sites (company) should be filled out if not covered by a separate licence)
6. Speciālās atļaujas (licences) izsniegšanas juridiskais pamatojums
Legal basis for authorisation (licence)
7. Zāļu valsts aģentūras atbildīgā amatpersona, kura pieņem lēmumu par speciālās atļaujas (licences) piešķiršanu
Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation

(vārds, uzvārds)

 
8. Paraksts    
Signature  
9. Datums  
Date  

10. Speciālai atļaujai (licencei) pievienotie pielikumi: (norāda 1. vai 2.pielikumu)
Annexes attached (ANNEX 1 or ANNEX 2)

Piezīme. Ja nepieciešams, papildus pievieno šādus pielikumus:
Optional Annexes as required:

1) 3.pielikumu "Uz līguma pamata iesaistīto ražošanas vietu adreses"
Annex 3. Addresses of Contract Manufacturing Sites.

2) 4.pielikumu "Uz līguma pamata iesaistīto laboratoriju adreses"
Annex 4. Addresses of Contract Laboratories.

3) 5.pielikumu "Kvalificētās personas vārds un uzvārds"
Annex 5. Name of a Qualified Person.

4) 6.pielikumu "Atbildīgo personu vārds un uzvārds"
Annex 6. Name of a Responsible Persons.

5) 7.pielikumu "Pārbaudes (inspekcijas) datums, kas ir par pamatu speciālās atļaujas (licences) piešķiršanai, pēdējās pārbaudes joma"
Annex 7. Date of Inspection on which Authorisation Granted, Scope of Last Inspection.

6) 8.pielikumu "Speciālās darbības veidi un atbildīgā(-s) persona(-s) par narkotisko un psihotropo zāļu ražošanu vai importēšanu".
Annex 8. Authorization for Special Operations and Name of Person(s) Responsible for Manufacturing or Importation of Narcotic and Psychotropic Medicinal Products.

Licences Nr. _______________ 1.pielikums
Licence No _______________ Annex 1

LICENCĒŠANAS JOMA (izdzēš tās nodaļas, kuras neattiecas)
SCOPE OF AUTHORISATION
(the sections which do not apply shall be deleted)

Farmaceitiskās darbības vietas nosaukums un adrese
Name and address of the site
Cilvēkiem paredzētās zāles
Human medicinal products

Veterinārās zāles
Veterinary medicinal products

ATĻAUTĀS DARBĪBAS
AUTHORISED OPERATIONS

Ražošanas darbības (saskaņā ar 1.daļu)
Manufacturing operations (according to Part 1)

Zāļu importēšana (saskaņā ar 2.daļu)
Importation of medicinal products (according to Part 2)

1.daļa. RAŽOŠANAS DARBĪBAS
Part 1. MANUFACTURING OPERATIONS
1.1. Sterilās zāļu formas
Sterile products
  1.1.1. Aseptiski iegūtas (pārstrādes darbības šādām zāļu formām)
Aseptically prepared (processing operations for the following dosage forms)

1.1.1.1. Šķidrumi liela tilpuma iepakojumā
Large volume liquids

1.1.1.2. Liofilizāti
Lyophilisates

1.1.1.3. Mīkstās zāļu formas
Semi-solids

1.1.1.4. Šķidrumi maza tilpuma iepakojumā
Small volume liquids

1.1.1.5. Cietās zāļu formas un implanti
Solids and implants

1.1.1.6. Citi aseptiski iegūti produkti (brīvs uzskaitījums)
Other aseptically prepared products (free text)

  1.1.2. Sterilizēti galaprodukti (pārstrādes darbības šādām zāļu formām)
Terminally sterilised (processing operations for the following dosage forms)

1.1.2.1. Šķidrumi liela tilpuma iepakojumā
Large volume liquids

1.1.2.2. Mīkstās zāļu formas
Semi-solids

1.1.2.3. Šķidrumi maza tilpuma iepakojumā
Small volume liquids

1.1.2.4. Cietās zāļu formas un implanti
Solids and implants

1.1.2.5. Citi sterilizēti galaprodukti (brīvs uzskaitījums)
Other terminally sterilised final products (free text)

  1.1.3. Tikai sērijas sertifikācija
Batch certification only
1.2. Nesterilās zāļu formas
Non-sterile products
  1.2.1. Nesterilās zāļu formas (pārstrādes darbības šādām zāļu formām)
Non-sterile products (processing operations for the following dosage forms)

1.2.1.1. Cietās kapsulas
Capsules, hard shell

1.2.1.2. Mīkstās kapsulas
Capsules, soft shell

1.2.1.3. Košļājamās gumijas
Chewing gums

1.2.1.4. Impregnētās matrices
Impregnated matrices

1.2.1.5. Šķidrumi ārīgai lietošanai
Liquids for external use

1.2.1.6. Šķidrumi iekšķīgai lietošanai
Liquids for internal use

1.2.1.7. Medicīniskās gāzes
Medicinal gases

1.2.1.8. Citas cietās zāļu formas
Other solid dosage forms

1.2.1.9. Aerosolu preparāti (zem spiediena)
Pressurised preparations

1.2.1.10. Radionuklīdu ģeneratori
Radionuclide generators

1.2.1.11. Mīkstās zāļu formas
Semi-solids

1.2.1.12. Supozitoriji
Suppositories

1.2.1.13. Tabletes
Tablets

1.2.1.14. Transdermālie plāksteri
Transdermal patches

1.2.1.15. Intraruminālās ierīces
Intraruminal devices

1.2.1.16. Lopbarības piedevas
Veterinary premixes

1.2.1.17. Citas nesterilās zāļu formas (brīvs uzskaitījums)
Other non-sterile medicinal products (free text)

  1.2.2. Tikai sērijas sertifikācija
Batch certification only
1.3. Bioloģiskas izcelsmes zāles
Biological medicinal products
  1.3.1. Bioloģiskas izcelsmes zāles (zāļu veidu saraksts)
Biological medicinal products (list of producēt types)

1.3.1.1. No cilvēka asinīm un plazmas iegūtas zāles
Blood products

1.3.1.2. Imunoloģiskie preparāti
Immunological products

1.3.1.3. Šūnu terapijas zāles
Cell therapy products

1.3.1.4. Gēnu terapijas zāles
Gene therapy products

1.3.1.5. Biotehnoloģijas preparāti
Biotechnology products

1.3.1.6. No cilvēka vai dzīvnieku materiāliem izdalīti preparāti
Human or animal extracted products

1.3.1.7. No audiem veidoti produkti
Tissue engineered products

1.3.1.8. Citas bioloģiskas izcelsmes zāles (brīvs uzskaitījums)
Other biological medicinal products (free text)

  1.3.2. Tikai sērijas sertifikācija (zāļu veidu saraksts)
Batch certification only (list of product types)

1.3.2.1. No cilvēka asinīm un plazmas iegūtas zāles
Blood products

1.3.2.2. Imunoloģiskie preparāti
Immunological products

1.3.2.3. Šūnu terapijas zāles
Cell therapy products

1.3.2.4. Gēnu terapijas zāles
Gene therapy products

1.3.2.5. Biotehnoloģijas preparāti
Biotechnology products

1.3.2.6. No cilvēka vai dzīvnieku materiāliem izdalīti preparāti
Human or animal extracted products

1.3.2.7. No audiem veidoti produkti
Tissue engineered products

1.3.2.8. Citas bioloģiskas izcelsmes zāles (brīvs uzskaitījums)
Other biological medicinal products (free text)

1.4. Citi produkti vai ražošanas darbības
Other products or manufacturing activity
  1.4.1. Ražošana:
Manufacturing of:

1.4.1.1. Augu izcelsmes zāles
Herbal products

1.4.1.2. Homeopātiskās zāles
Homoeopathic products

1.4.1.3. Citi (brīvs uzskaitījums)
Other (free text)

  1.4.2. Aktīvo vielu vai palīgvielu, vai galaprodukta sterilizācija
Sterilisation of active substances or excipients, or finished product

1.4.2.1. Filtrēšana
Filtration

1.4.2.2. Sterilizācija ar karstu sausu gaisu
Dry heat

1.4.2.3. Sterilizācija ar ūdens tvaiku
Moist heat

1.4.2.4. Ķīmiskā sterilizācija
Chemical

1.4.2.5. Apstarošana ar gamma stariem
Gamma irradiation

1.4.2.6. Apstarošana ar elektronu kūli
Electron beam

  1.4.3. Citi (brīvs uzskaitījums)
Other (free text)
1.5. Tikai iepakošana
Packaging only
  1.5.1. Primārā iepakošana:
Primary packing

1.5.1.1. Cietās kapsulas
Capsules, hard shell

1.5.1.2. Mīkstās kapsulas
Capsules, soft shell

1.5.1.3. Košļājamās gumijas
Chewing gums

1.5.1.4. Impregnētās matrices
Impregnated matrices

1.5.1.5. Šķidrumi ārīgai lietošanai
Liquids for external use

1.5.1.6. Šķidrumi iekšķīgai lietošanai
Liquids for internal use

1.5.1.7. Medicīniskās gāzes
Medicinal gases

1.5.1.8. Citas cietās zāļu formas
Other solid dosage forms

1.5.1.9. Aerosolu preparāti (zem spiediena)
Pressurised preparations

1.5.1.10. Radionuklīdu ģeneratori
Radionuclide generators

1.5.1.11. Mīkstās zāļu formas
Semi-solids

1.5.1.12. Supozitoriji
Suppositories

1.5.1.13. Tabletes
Tablets

1.5.1.14. Transdermālie plāksteri
Transdermal patches

1.5.1.15. Intraruminālās ierīces
Intraruminal devices

1.5.1.16. Lopbarības piedevas
Veterinary premixes

1.5.1.17. Citas nesterilās zāļu formas (brīvs uzskaitījums)
Other non-sterile dosage forms (free text)

  1.5.2. Sekundārā iepakošana
Secondary packing
1.6. Kvalitātes kontroles veikšana
Quality control testing
  1.6.1. Mikrobioloģiski: sterilitāte
Microbiologically: sterility

1.6.2. Mikrobioloģiski: nesterilo zāļu formu tīrība
Microbiologically: microbiological contamination of non - sterile dosage forms

1.6.3. Ķīmiski vai fizikāli
Chemically or physically

1.6.4. Bioloģiski
Biologically

 
Jebkuri ierobežojumi vai paskaidrojošas piezīmes par šīm ražošanas darbībām
Any restrictions or clarifying remarks related to the scope of these manufacturing operations
2.daļa. ZĀĻU IMPORTĒŠANA
Part 2. IMPORTATION OF MEDICINAL PRODUCTS
2.1. Importēto zāļu kvalitātes kontroles veikšana
Quality control of imported medicinal products
  2.1.1. Mikrobioloģiski: sterilitāte
Microbiologically: sterility

2.1.2. Mikrobioloģiski: nesterilo zāļu formu tīrība
Microbiologically: microbiological contamination of non - sterile dosage forms

2.1.3. Ķīmiski vai fizikāli
Chemically or physically

2.1.4. Bioloģiski
Biologically

2.2. Importēto zāļu sērijas sertifikācija
Batch certification of imported medicinal products
  2.2.1. Sterilās zāļu formas
Sterile dosage forms

2.2.1.1. Aseptiski iegūtas
Aseptically prepared

2.2.1.2. Sterilizēti galaprodukti (zāļu formu saraksts)
Terminally sterilised end products (list of dosage forms)

  2.2.2. Nesterilās zāļu formas
Non-sterile dosage forms
  2.2.3. Bioloģiskas izcelsmes zāles
Biological products

2.2.3.1. No cilvēka asinīm un plazmas iegūtas zāles
Blood products

2.2.3.2. Imunoloģiskie preparāti
Immunological products

2.2.3.3. Šūnu terapijas zāles
Cell therapy products

2.2.3.4. Gēnu terapijas zāles
Gene therapy products

2.2.3.5. Biotehnoloģijas preparāti
Biotechnology products

2.2.3.6. No cilvēka vai dzīvnieku materiāliem izdalīti preparāti
Human or animal extracted products

2.2.3.7. No audiem veidoti produkti
Tissue engineered products

2.2.3.8. Citas bioloģiskas izcelsmes zāles (brīvs uzskaitījums)
Other biological medicinal products (free text)

2.3. Citas importēšanas darbības (jebkura cita importēšanas darbība, kas nav iekļauta iepriekš minētajā uzskaitījumā)
Other importation activities (any other importation activity that is not covered above)
  2.3.1. Fiziskas importēšanas vieta
Site of physical importation

2.3.2. Starpprodukta, kurš tiek pakļauts turpmākai apstrādei, importēšana
Importation of intermediate which undergoes further processing

2.3.3. Bioloģiskas izcelsmes aktīvā viela
Biological active substance

2.3.4. Citas (brīvs uzskaitījums)
Other (free text)

 
Jebkuri ierobežojumi vai paskaidrojošas piezīmes par šīm ražošanas darbībām
Any restrictions or clarifying remarks related to the scope of these manufacturing operations

Licences Nr. _______________ 2.pielikums
Licence No _______________ Annex 2

LICENCĒŠANAS JOMA (izdzēš tās nodaļas, kuras neattiecas vai atzīmē jā/nē)
SCOPE OF AUTHORISATION
(deleted the sections that do not apply or use yes/no)

Ražošanas vai importēšanas vietas nosaukums un adrese
Name and address of the manufacturing or importing site
 
Cilvēkiem paredzētās pētāmās zāles
Investigational medicinal products for human use
ATĻAUTĀS DARBĪBAS
AUTHORISED OPERATIONS

Pētāmo zāļu ražošanas darbības (saskaņā ar 1.daļu)
Manufacturing operations of investigational medicinal products (according to Part 1)

Pētāmo zāļu importēšana (saskaņā ar 2.daļu)
Importation of investigational medicinal products (according to Part 2)

1.daļa. PĒTĀMO ZĀĻU RAŽOŠANAS DARBĪBAS
Part 1 MANUFACTURING OPERATIONS OF INVESTIGATIONAL MEDICINAL PRODUCTS
1.1. Pētāmo zāļu sterilās formas
Sterile forms investigational medicinal products
  1.1.1. Aseptiski iegūtas (pārstrādes darbības šādām zāļu formām)
Aseptically prepared (processing operations for the following dosage forms)

1.1.1.1. Šķidrumi liela tilpuma iepakojumā
Large volume liquids

1.1.1.2. Liofilizāti
Lyophilisates

1.1.1.3. Mīkstās zāļu formas
Semi-solids

1.1.1.4. Šķidrumi maza tilpuma iepakojumā
Small volume liquids

1.1.1.5. Cietās zāļu formas un implanti
Solids and implants

1.1.1.6. Citi aseptiski iegūti produkti (brīvs uzskaitījums)
Other aseptically prepared products (free text)

  1.1.2. Sterilizēti galaprodukti (pārstrādes darbības šādām zāļu formām)
Terminally sterilised final products (processing operations for the following dosage forms)

1.1.2.1. Šķidrumi liela tilpuma iepakojumā
Large volume liquids

1.1.2.2. Mīkstās zāļu formas
Semi-solids

1.1.2.3. Šķidrumi maza tilpuma iepakojumā

Small volume liquids

1.1.2.4. Cietās zāļu formas un implanti
Solids and implants

1.1.2.5. Citi sterilizēti galaprodukti (brīvs uzskaitījums)
Other terminally sterilised final products (free text)

  1.1.3. Sērijas sertifikācija
Batch certification only
1.2. Pētāmo zāļu nesterilās formas
Non-sterile investigational medicinal products
  1.2.1. Nesterilās zāļu formas (pārstrādes darbības šādām zāļu formām)
Non-sterile dosage forms (processing operations for the following dosage forms)

1.2.1.1. Cietās kapsulas
Capsules, hard shell

1.2.1.2. Mīkstās kapsulas
Capsules, soft shell

1.2.1.3. Košļājamās gumijas
Chewing gums

1.2.1.4. Impregnētās matrices
Impregnated matrices

1.2.1.5. Šķidrumi ārīgai lietošanai
Liquids for external use

1.2.1.6. Šķidrumi iekšķīgai lietošanai
Liquids for internal use

1.2.1.7. Medicīniskās gāzes
Medicinal gases

1.2.1.8. Citas cietās zāļu formas
Other solid dosage forms

1.2.1.9. Aerosolu preparāti (zem spiediena)
Pressurised preparations

1.2.1.10. Radionuklīdu ģeneratori
Radionuclide generators

1.2.1.11. Mīkstās zāļu formas
Semi-solids

1.2.1.12. Supozitoriji
Suppositories

1.2.1.13. Tabletes
Tablets

1.2.1.14. Transdermālie plāksteri
Transdermal patches

1.2.1.15. Citas nesterilās zāļu formas (brīvs uzskaitījums)
Other non-sterile dosage forms (free text)

  1.2.2. Sērijas sertifikācija
Batch certification only
1.3. Bioloģiskas izcelsmes pētāmās zāles
Biological investigational medicinal products
  1.3.1. Bioloģiskas izcelsmes zāles (zāļu veidu saraksts)
Biological medicinal products (list of product types)

1.3.1.1. No cilvēka asinīm un plazmas iegūtas zāles
Blood products

1.3.1.2. Imunoloģiskie preparāti
Immunological products

1.3.1.3. Šūnu terapijas zāles
Cell therapy products

1.3.1.4. Gēnu terapijas zāles
Gene therapy products

1.3.1.5. Biotehnoloģijas preparāti
Biotechnology products

1.3.1.6. No cilvēka vai dzīvnieku materiāliem izdalīti preparāti
Human or animal extracted products

1.3.1.7. No audiem veidoti produkti
Tissue engineered products

1.3.1.8. Citas bioloģiskas izcelsmes zāles (brīvs uzskaitījums)
Other biological medicinal products (free text)

1.3.2. Sērijas sertifikācija (zāļu veidu saraksts)
Batch certification only (list of product types)

1.3.2.1. No cilvēka asinīm un plazmas iegūtas zāles
Blood products

1.3.2.2. Imunoloģiskie preparāti
Immunological products

1.3.2.3. Šūnu terapijas zāles
Cell therapy products

1.3.2.4. Gēnu terapijas zāles
Gene therapy products

1.3.2.5. Biotehnoloģijas preparāti
Biotechnology products

1.3.2.6. No cilvēka vai dzīvnieku materiāliem izdalīti preparāti
Human or animal extracted products

1.3.2.7. No audiem veidoti produkti
Tissue engineered products

1.3.2.8. Citas bioloģiskas izcelsmes zāles (brīvs uzskaitījums)
Other biological medicinal products (free text)

1.4. Citas pētāmās zāles vai ražošanas darbības
Other investigational medicinal products or manufacturing activity)
  1.4.1. Ražošana:
Manufacturing of

1.4.1.1. Augu izcelsmes zāles
Herbal products

1.4.1.2. Homeopātiskās zāles
Homoeopathic products

1.4.1.3. Citas (brīvs uzskaitījums)
Other (free text)

  1.4.2. Aktīvo vielu vai palīgvielu, vai galaprodukta sterilizācija"
Sterilisation of active substances or excipients, or finished product:

1.4.2.1. Filtrēšana
Filtration

1.4.2.2. Sterilizācija ar karstu sausu gaisu
Dry heat

1.4.2.3. Sterilizācija ar ūdens tvaiku
Moist heat

1.4.2.4. Ķīmiskā sterilizācija
Chemical

1.4.2.5. Apstarošana ar gamma stariem
Gamma irradiation

1.4.2.6. Apstarošana ar elektronu kūli
Electron beam

  1.4.3. Citi (brīvs uzskaitījums)
Other
(free text)
1.5. Tikai iepakošana
Packaging only
  1.5.1. Primārā iepakošana
Primary packing

1.5.1.1. Cietās kapsulas
Capsules, hard shell

1.5.1.2. Mīkstās kapsulas
Capsules, soft shell

1.5.1.3. Košļājamās gumijas
Chewing gums

1.5.1.4. Impregnētās matrices
Impregnated matrices

1.5.1.5. Šķidrumi ārīgai lietošanai
Liquids for external use

1.5.1.6. Šķidrumi iekšķīgai lietošanai
Liquids for internal use

1.5.1.7. Medicīniskās gāzes
Medicinal gases

1.5.1.8. Citas cietās zāļu formas
Other solid dosage forms

1.5.1.9. Aerosolu preparāti (zem spiediena)
Pressurised preparations

1.5.1.10. Radionuklīdu ģeneratori
Radionuclide generators

1.5.1.11. Mīkstās zāļu formas
Semi-solids

1.5.1.12. Supozitoriji
Suppositories

1.5.1.13. Tabletes
Tablets

1.5.1.14. Transdermālie plāksteri
Transdermal patches

1.5.1.15. Citas nesterilās zāļu formas (brīvs uzskaitījums)
Other non-sterile medicinal product (free text)

  1.5.2. Sekundārā iepakošana
Secondary packing
1.6. Kvalitātes kontroles veikšana
Quality control
  1.6.1. Mikrobioloģiski: sterilitāte
Microbiologically: sterility

1.6.2. Mikrobioloģiski: nesterilo zāļu formu tīrība
Microbiologically: microbiological contamination of non - sterile dosage forms

1.6.3. Ķīmiski vai fizikāli
Chemically or physically

1.6.4. Bioloģiski
Biologically

 
Jebkuri ierobežojumi vai paskaidrojošas piezīmes par šīm ražošanas darbībām
Any restrictions or clarifying remarks related to the scope of these manufacturing operations
2.daļa. PĒTĀMO ZĀĻU IMPORTĒŠANA
Part 2. IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS
2.1. Importēto pētāmo zāļu kvalitātes kontroles veikšana
Quality control of imported investigational medicinal products
  2.1.1. Mikrobioloģiski: sterilitāte
Microbiologically: sterility

2.1.2. Mikrobioloģiski: nesterilo zāļu formu tīrība
Microbiologically: microbiological contamination of non - sterile dosage forms

2.1.3. Ķīmiski vai fizikāli
Chemically or physically

2.1.4. Bioloģiski
Biologically

2.2. Importēto pētāmo zāļu sērijas sertifikācija
Batch certification of imported investigational medicinal products
  2.2.1. Sterilās zāļu formas
Sterile products

2.2.1.1. Aseptiski iegūtas
Aseptically prepared

2.2.1.2. Sterilizēti galaprodukti
Terminally sterilised final products

  2.2.2. Nesterilās zāļu formas
Non-sterile dosage forms
  2.2.3. Bioloģiskas izcelsmes zāles
Biological products

2.2.3.1. No cilvēka asinīm un plazmas iegūtas zāles
Blood products

2.2.3.2. Imunoloģiskie preparāti
Immunological products

2.2.3.3. Šūnu terapijas zāles
Cell therapy products

2.2.3.4. Gēnu terapijas zāles
Gene therapy products

2.2.3.5. Biotehnoloģijas preparāti
Biotechnology products

2.2.3.6. No cilvēka vai dzīvnieku materiāliem izdalīti preparāti
Human or animal extracted products

2.2.3.7. No audiem veidoti produkti
Tissue engineered products

2.2.3.8. Citas bioloģiskas izcelsmes zāles (brīvs uzskaitījums)
Other biological medicinal products (free text)

2.3. Citas importēšanas darbības (jebkura cita importēšanas darbība, kas nav iekļauta augšminētajā uzskaitījumā)
Other importation activities (any other importation activity that is not covered above)
  2.3.1. Fiziskas importēšanas vieta
Site of physical importation

2.3.2. Starpprodukta, kurš tiek pakļauts turpmākai apstrādei, importēšana
Importation of intermediate which undergoes further processing

2.3.3. Bioloģiskas izcelsmes aktīvā viela
Biological active substance

2.3.4. Citas (brīvs uzskaitījums)
Other (free text)

 
Jebkuri ierobežojumi vai paskaidrojošas piezīmes par šīm ražošanas darbībām
Any restrictions or clarifying remarks related to the scope of these manufacturing operations

Licences Nr. _______________ 3.pielikums
Licence No _______________ Annex 3

Līgumražotāja(-u) ražošanas vietas(-u) adrese(-es)
Address(es) of contract manufacturing sites

Licences Nr. _______________ 4.pielikums
Licence No _______________ Annex 4

Laboratorijas(-u) adrese(-es), kura(-as) veic kvalitātes kontroli, pamatojoties uz līgumu
Address(es) of contract laboratory(ies) performing quality control

Licences Nr. _______________ 5.pielikums
Licence No _______________ Annex 5

Kvalificētās(-o) personas(-u) vārds, uzvārds
Name, surname of a qualified person(s)

Licences Nr. _______________ 6.pielikums
Licence No _______________ Annex 6

Par kvalitātes kontroli atbildīgā persona (vārds, uzvārds)
Name, surname of a person(s) responsible for quality control
Par ražošanu atbildīgā persona (vārds, uzvārds)
Name, surname of a person(s) responsible for production

Licences Nr. _______________ 7.pielikums
Licence No_______________ Annex 7

Pārbaudes (inspekcijas) datums, kas ir par pamatu speciālās atļaujas (licences) piešķiršanai ____________________________________________
Date of inspection on which authorisation granted

Pēdējās inspekcijas joma
Scope of last inspection

Licences Nr. _______________ 8.pielikums
Licence No_______________ Annex 8

Speciālās darbības veidi (vajadzīgo atzīmēt ar x) un par narkotisko un psihotropo zāļu ražošanu vai importēšanu atbildīgā(-s) persona(-s)
Particular authorised activities (mark "X" where appropriate) and responsible person(s)

Speciālās darbības veids
Particular activity

Par narkotisko un psihotropo zāļu ražošanu vai importu atbildīgās(-o) personas(-u) amats, vārds, uzvārds
Name, surname, position of a person(-s) responsible for manufacturing of narcotic and psychotropic medicinal products

narkotisko zāļu ražošana
manufacturing of narcotic medicinal products
 
narkotisko zāļu importēšana
importing of narcotic medicinal products
 
psihotropo zāļu ražošana
manufacturing of psychotropic medicinal products
 
psihotropo zāļu importēšana
importing of psychotropic medicinal products
 

Note. The detail of the document "signature" shall not be completed if the electronic document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

 

Annex 8
Cabinet Regulation No. 800
19 October 2011

[25 June 2013]

LATVIJAS REPUBLIKA
ZĀĻU VALSTS AĢENTŪRA

 

REPUBLIC OF LATVIA
STATE AGENCY OF MEDICINES

 
 

(adrese, reģistrācijas numurs, tālruņa numurs, faksa numurs, e-pasta adrese)

 

(address, registration number, phone number, fax number, e-mail)

SPECIĀLĀ ATĻAUJA (LICENCE)
AKTĪVO VIELU (AFV) RAŽOŠANAI

AUTHORISATION (LICENCE) FOR
ACTIVE PHARMACEUTICAL INGREDIENTS (API) MANUFACTURING

1. Speciālās atļaujas (licences) sērija, numurs
Serial number, number of authorisation (licence)
2. Speciālās atļaujas (licences) turētāja firma, reģistrācijas numurs komercreģistrā
Name, registration number of authorisation (licence) holder
3. Speciālās atļaujas (licences) turētāja juridiskā adrese
Legally registered address of authorisation (licence) holder
4. Ražošanas vietas(-u) (farmaceitiskās darbības vietas(-u)) adrese(-es)
Address(-es) of manufacturing site(-s) (site(-es) of pharmaceutical activity(-ies))
5. Atbildīgās amatpersonas vārds, uzvārds
Name, surname of responsible official

6. Speciālās atļaujas (licences) joma
Scope of authorisation (licence)

6.1. Aktīvo vielu ražošana, tai skaitā (izdzēš tās nodaļas, kuras neattiecas)
Active pharmaceutical ingredients manufacturing, including (the sections which do not apply shall be deleted)

sterilās aktīvās vielas
Sterile active pharmaceutical ingredients

bioloģiskās izcelsmes vielas
Biological substances

6.2. Speciālās darbības veidi (vajadzīgo atzīmēt ar "x") un par to izpildi atbildīgā(-s) persona(-s)
Particular authorised activities (mark "X" where appropriate) and responsible person(-s)

Speciālās darbības veids
Particular activity

Par narkotisko un psihotropo vielu ražošanu atbildīgās(-o) personas(-u) amats, vārds, uzvārds
Name, surname, position of a person(-s) responsible for manufacturing of narcotic and psychotropic substances

narkotisko vielu ražošana
manufacturing of narcotic substances
 
psihotropo vielu ražošana
manufacturing of psychotropic substances
 

6.3. Citas darbības
Other activities

etilspirta fasēšana
Ethyl alcohol primary packaging

7. Laboratorijas(-u) adrese(-es), kuras veic kvalitātes kontroli, pamatojoties uz līgumu
Address(-es) of contract laboratory(-ies) performing contract quality control
8. Speciālās atļaujas (licences) izsniegšanas juridiskais pamatojums
Legal basis for issuing the authorisation (licence)
9. Licence derīga līdz
Date of expiration
10. Zāļu valsts aģentūras direktora vārds, uzvārds
Name, surname of responsible official of the competent authority granting the manufacturing authorisation
11. Paraksts  
Signature  
12. Datums  
Date  
Licences pielikumi un pielikumu lapu skaits
Annexes and number of pages

Note. The detail of the document "signature" shall not be completed if the document has been drawn up in accordance with the laws and regulations regarding drawing up of electronic documents.

Minister for Health J. Bārzdiņš

 


Translation © 2018 Valsts valodas centrs (State Language Centre)

 
Document information
Status:
In force
in force
Issuer: Cabinet of Ministers Type: regulation Document number: 800Adoption: 19.10.2011.Entry into force: 28.10.2011.Publication: Latvijas Vēstnesis, 170, 27.10.2011.
Language:
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