Procedures for the Acquisition, Storage, Use, Registration and Disposal of Medicinal Products in Medical Treatment Institutions and Social Care Institutions

Issued pursuant to
Section 5, Clause 7 of the Pharmaceutical Law and Section 37, Clause 4
of the law On the Procedures for the Legal Trade of Narcotic and Psychotropic
Substances and Medicinal Products

[10 March 2009]

I. General Provisions

1. This Regulation prescribes the procedures by which medical treatment institutions and social care institutions shall acquire, store and use medicinal products (including medicinal products, which contain very dangerous narcotic substances and equivalent psychotropic substances that are allowed to be used for medical and scientific purposes and are included in Register II of narcotic substances, psychotropic substances and precursors to be controlled in Latvia (hereinafter - the narcotic substances and narcotic medicinal products) and dangerous psychotropic substances that may be abused and are included in Register III of narcotic substances, psychotropic substances and precursors to be controlled in Latvia (hereinafter - the psychotropic substances and psychotropic medicinal products)), as well as the procedures by which narcotic and psychotropic substances shall be registered and disposed of.

[25 January 2011]

2. The head of a medical treatment institution and a social care institution, pursuant to the work profile and structure of the medical treatment institution or the social care institution, shall determine detailed procedures for the fulfilment of this Regulation by specifying an official who shall be responsible for ensuring the procedures for the acquisition, storage, use, registration and disposal of medicinal products (also the narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products, if such are used or are intended to be used) in the medical treatment institution or the social care institution (hereinafter - the responsible official) and, where appropriate, also the responsible officials in units of the medical treatment institution or the social care institution.

[25 January 2011]

3. The head of a medical treatment institution and a social care institution shall:

3.1. be responsible for ensuring the procedures for the acquisition, storage and use (hereinafter - the trade) of medicinal products, as well as for the registration and disposal of the narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products (if any) and the measures necessary to prevent the diversion of medicinal products into illegal trade and abuse of medicinal products;

3.2. ensure that officials of the Health Inspectorate (hereinafter - the Inspectorate) would have free access to the sites of the trade and registration of medicinal products and to all documents related to the trade, registration and disposal of medicinal products in the presence of the responsible official.

[8 April 2008; 10 March 2009; 25 January 2011]

4. The head of a medical treatment institution and a social care institution shall appoint a person with pharmaceutical or medical education as the responsible official. The head of an inpatient medical treatment institution shall appoint a person with pharmaceutical education as the responsible person.

[10 March 2009]

4.¹ A closed type pharmacy shall be established in multi-purpose hospitals. A closed type pharmacy may be established also in other inpatient medical treatment institutions.

[10 March 2009; Paragraph shall come into force on 1 January 2010, see Paragraph 2 of the Amendment]

5. The National Health Service shall:

5.1. develop a list of the medicinal products, which are necessary for the provision of inpatient health care services paid from the State budget (hereinafter - the inpatient health care services), (hereinafter - the list of medicinal products to be used) in co-operation with specialists of medical treatment institutions and representatives of professional physician's associations within the time period referred to in Annex 1 to this Regulation;

5.2. evaluate and provide an opinion on medicinal products necessary to a particular hospital, which are used in addition to the medicinal products included in the list referred to in Sub-paragraph 5.1 of this Regulation (hereinafter - the list of medicinal products to be additionally used);

5.3. publish the list of medicinal products to be used on its website by indicating:

5.3.1. the seven-digit code and identification number of the anatomical therapeutic chemical classification of medicinal products (hereinafter - the ATC classification);

5.3.2. the general name of a medicinal product;

5.3.3. the pharmaceutical form and strength;

5.3.4. the date when medicinal products have been included in the list of medicinal products to be used;

5.3.5. the medicinal products referred to in Sub-paragraph 5.5 of this Regulation and the procurement prices thereof;

5.4. update the list of medicinal products to be used once a year;

5.5. acting as the centralised procurement authority - a representative of the commissioning party, if the payer is the medical treatment institution referred to in Paragraph 12 of this Regulation, negotiated procedures shall be applied in accordance with the procedures specified by the Public Procurement Law, without publishing a notice of contract, of the medicinal products included in the list of medicinal products to be used, if within the framework of general name of the medicinal product (seven characters of the ATC classification) they are the only medicinal product that are allowed to be distributed in the Republic of Latvia, and only one supplier is entitled to supply them to the medical treatment institutions referred to in Paragraph 12 of this Regulation.

[31 August 2010; 4 December 2012]

6. The National Health Service shall compile the list of medicinal products to be used in accordance with the ATC classification by indicating the therapeutic groups of medicinal products and general names of medicinal products (seven characters of the ATC classification).

[31 August 2010; 4 December 2012]

7. Medicinal products shall be included on the list of medicinal products to be used if they conform to the following criteria:

7.1. medicinal products belong to a group of medicinal products (three characters of the ATC classification), which conforms to the treatment schemes of diseases to be treated in a medical treatment institution or to the treatment schemes developed by professional physicians' associations, or to international guidelines of medical treatment;

7.2. medicinal products have the lowest costs of medical treatment in comparison with other medicinal products that have equal therapeutic efficacy and side effects;

7.3. in comparison with another available type of medical treatment, advantages of medicinal products in the sense of therapeutic efficacy and side effects have been proved to a specific group of patients, if medicinal products have higher costs of medical treatment.

8. Medicinal products shall be included on the list of medicinal products to be additionally used if they conform to the following criteria:

8.1. the medicinal products belong to a group of medicinal products (three characters of the ATC classification), which conforms to the profile of health care services provided in a medical treatment institution, and advantages of therapeutic efficacy thereof have been proved to a specific target group of patients treated in the medical treatment institution in relation to the death rate, occurrence of disability or reduction of the frequency of complications and reduction of remission of the disease;

8.2. in comparison with another available type of medical treatment, advantages of medicinal products in the sense of therapeutic efficacy and side effects have been proved to a specific group of patients, if medicinal products have higher costs of medical treatment;

8.3. costs of the medicinal products are commensurable with the amount of financial resources, which are granted to the medical treatment institution from the inpatient health care services of the State budget.

9. The head of a multipurpose hospital shall establish a drug committee. Other medical treatment institutions may also establish a drug committee. The composition of the drug committee shall include persons having a medical and pharmaceutical education, and it shall act in accordance with the by-laws approved by the head of the medical treatment institution, in which tasks of the drug committee are specified.

[10 March 2009]

10. A drug committee shall have the following functions:

10.1. to organize the drawing up of the list of medicinal products to be used in the particular medical treatment institution and updating thereof by taking into account that the costs of medicinal products should be commensurable with the amount of the financial resources that have been granted to the medical treatment institution from the State budget, and to submit an application to the National Health Service for the assessment of the use of the medicinal products included in the list of medicinal products to be additionally used and for the provision of an opinion;

10.2. to ensure the compilation of information on consumption of medicinal products in a medical treatment institution, analysing thereof and preparation of procurement forecast, precluding determination of unjustifiably large amount of procurement;

10.3. to co-ordinate the organisation of procurement tenders of medicinal products and medical devices necessary for the needs of a medical treatment institution in accordance with the laws and regulations regarding public procurements;

10.4. to ensure the analysis and improvement of the system for the trade and registration of medicinal products of a medical treatment institution;

10.5. to promote rational division and use of medicinal products in a medical treatment institution by ensuring that a patient receives the necessary dosage of medicinal products at specified times in conformity with the clinical needs at as low costs as possible and precise information regarding the use of such medicinal products;

10.6. to promote the monitoring of the side effects caused by the use of medicinal products;

10.7. to provide medical practitioners with an opportunity to receive independent information on medicinal products.

[10 March 2009; 31 August 2010; 4 December 2012]

11. If a drug committee has not been established in a medical treatment institution, the head of the medical treatment institution shall be responsible for ensuring the functions referred to in Paragraph 10 of this Regulation.

[10 March 2009]

11.¹ If a clinical pharmacist is employed in a medical treatment institution, he or she has the following rights:

11.¹1. in co-operation with medical practitioners to determine the relevant pharmacotherapy for a patient by taking into account the diagnosis, symptoms and results of examinations, as well as safety, efficiency and economical principles in respect of indications, dosage, frequency and duration of use of medicinal products;

11.¹2. to organise direct distribution of medicinal products to patients;

11.¹3. to carry out direct supervision of the use of medicinal products by following the results of examinations on regular basis, surveying the patient and recording the supervision data upon, where necessary, initiating corrections of pharmacotherapy;

11.¹4. to carry out direct supervision of the side effects caused by the use of medicinal products;

11.¹5. to provide consultations to medical practitioners concerning pharmacokinetic, pharmacodynamic and other issues related to prescription of medicinal products;

11.¹6. to advise patients on the use of medicinal products;

11.¹7. to participate in work of the drug committee;

11.¹8. to perform the duties of the responsible official referred to in Paragraph 4 of this Regulation, unless they are not assigned to another person;

11.¹9. to participate in organising of clinical trials (if any are being performed in the institution) and supervision of the course thereof;

11.¹10. to participate in other research, as well as educational events.

[10 March 2009]

12. The head of such medical treatment institution, which is directly financed from the State budget or with which the Centre of Health Economic has entered into a contract for the provision of inpatient health care services or emergency medical assistance, shall ensure that the medicinal products which are not procured in centralised form are acquired by complying with the principles of the economically most advantageous offer. General names of medicinal products, which conform to the seven characters of the ATC classification, shall be included in documentation of the procurement procedure.

[31 August 2010; 4 December 2012]

12.¹ In accordance with the laws and regulations regarding the distribution of medicinal products, a parallel distributor has the right to participate in a procurement tender of medicinal products even if he or she has submitted a notice (notification) to the European Medicines Agency, however, he or she has not yet received a notification of the European Medicines Agency where the completion of the inspection of the notification provided by the parallel distributor is indicated. In accordance with the laws and regulations regarding the distribution of medicinal products, a parallel importer has the right to participate in a procurement tender of medicinal products even if he or she has submitted an application to the State Agency of Medicines for the receipt of a permit for the distribution of parallel imported medicinal products, however, he or she has not yet received a permit for the distribution of parallel imported medicinal products.

[10 March 2009]

13. The following institutions are entitled to acquire medicinal products pursuant to the profile of the provided health care services:

13.1. a medical treatment institution which conforms to the mandatory requirements specified in the laws and regulations regarding medical treatment institutions and units thereof;

13.2. a social care institution which conforms to the requirements specified in the laws and regulations regarding social care institutions.

14. The medical treatment institutions or social care institutions referred to in Paragraph 13 of this Regulation shall acquire medicinal products only from such pharmacy, drug wholesaler or medicinal product manufacturer, which has received a special authorisation (licence) for pharmaceutical activity. Medical treatment institutions or social care institutions are entitled to acquire medicinal products from the State material reserves.

[19 April 2016]

II. Acquisition of Medicinal Products

15. A medical treatment institution with a closed type pharmacy that has received such special authorisation (licence) for the opening (operation) of a pharmacy, in the annex of which activity involving the narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products is allowed, shall acquire medicinal products, including also he narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products, in a pharmacy, a drug wholesaler or from a medicinal product manufacturer. The head of the pharmacy shall ensure the acquisition, storage and dispensation of medicinal products to units of the medical treatment institution.

[25 January 2011]

16. A medical treatment institution without a closed type pharmacy is entitled to acquire medicinal products, including also the psychotropic substances and psychotropic medicinal products, in a pharmacy or a closed type pharmacy of another medical treatment institution. It is allowed to acquire medicinal products in a drug wholesaler, including also the narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products, or to acquire the narcotic substances and narcotic medicinal products in the pharmacy, if an examination deed issued by the Inspectorate has been received, in which a corresponding decision on the acquisition of medicinal products is indicated. For a medical treatment institution that complies with the status of vaccination institution in accordance with the laws and regulations regarding vaccination an inspection deed issued by the Inspectorate, in which a decision on the acquisition of medicinal products has been indicated, is not required for the receipt of vaccines from a drug wholesaler.

[10 March 2009; 25 January 2011]

17. A social care institution is entitled to acquire medicinal products in a pharmacy. It shall be allowed to acquire medicinal products, including also the narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products, in a drug wholesaler or to acquire the narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products in a pharmacy, if an examination deed issued by the Inspectorate has been received, in which a corresponding decision on the acquisition of medicinal products is indicated.

[25 January 2011]

18. In order to receive the examination deed referred to in Paragraphs 16 and 17 of this Regulation, the head of a medical treatment institution or a social care institution shall submit to the Inspectorate an application (Annex 2) and copies of documents by presenting the originals.

[10 March 2009]

19. If information indicated in the application or documents is incomplete or inaccurate or if doubts regarding the veracity of information occur, the Inspectorate is entitled to request additional information. The period of time until receipt of additional information shall not be included in the term specified for the performance of examination.

20. After receipt of the application and the necessary documents, an official of the Inspectorate shall examine the procedures of the trade of medicinal products and of registration and disposal of the narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products (if such are used or are intended to be used) in a medical treatment institution or a social care institution.

[25 January 2011]

21. An examination deed shall be drawn up by an official of the Inspectorate on the examination in a medical treatment institution or a social care institution referred to in Paragraph 20 of this Regulation. The following information shall be indicated in the deed:

21.1. the location, address, date and time of drawing up of the examination deed;

21.2. the name of the medical treatment institution or the social care institution;

21.3. the date of the previous examination (if any);

21.4. the official of the inspection (given name, surname and position) who performed the examination;

21.5. the responsible official of the medical treatment institution or the social care institution (given name, surname) or another official (given name, surname and position) who participates in the examination;

21.6. activities performed, and facts established during the examination;

21.7. the established deficiencies and violations by indicating the specific section or paragraph of a law or regulation and the period of time for the elimination of deficiencies;

21.8. one of the following decisions:

21.8.1. it is allowed to acquire medicinal products included on the list of medicinal products to be used and the list of medicinal producs to be additionally used at a drug wholesaler. It shall be indicated separately that it is allowed to acquire the narcotic substances and narcotic medicinal products or the psychotropic substances and psychotropic medicinal products;

21.8.2. it is allowed to acquire medicinal products included on the list of medicinal products to be used and the list of medicinal products to be additionally used at a drug wholesaler after elimination of the detected deficiencies and informing the Inspectorate on the elimination of deficiencies. It shall be indicated separately that it is allowed to acquire the narcotic substances and narcotic medicinal products or the psychotropic substances and psychotropic medicinal products;

21.8.3. it is allowed to acquire the narcotic substances and narcotic medicinal products or the psychotropic substances and psychotropic medicinal products in a pharmacy;

21.8.4. it is not allowed to acquire medicinal products (including the narcotic substances and narcotic medicinal products and the psychotropic substances and psychotropic medicinal products) at a drug wholesaler.

[10 March 2009; 25 January 2011]

22. The examination deed shall be drawn up in two copies. One copy shall be issued to the medical treatment institution or the social care institution, in which the examination was performed; the other copy shall be kept in record-keeping of the Inspectorate. The examination deed shall be signed by an official of the Inspectorate and the person referred to in Sub-paragraph 21.5 of this Regulation who has the right to make notes regarding the process of the performed examination in the examination deed. The examination deed shall be valid for three years, except in case where the Inspectorate performs an exceptional examination (without prior notice) and draws up the examination deed referred to in Paragraph 21 of this Regulation or if it performs examination on the basis of the application referred to in Paragraph 18 and the information referred to in Paragraph 27 of this Regulation.

[10 March 2009]

23. When performing an exceptional examination (without prior notice) in a medical treatment institution or a social care institution, officials of the Inspectorate shall compile an examination deed in accordance with Paragraph 21 of this Regulation and:

23.1. take one of the decisions referred to in Sub-paragraphs 21.8.2 or 21.8.4 of this Regulation:

23.1.1. if the deficiencies found in the previous examination have not been eliminated in the specified period of time;

23.1.2. if violations in the trade of narcotic and psychotropic substances and medicinal products or in the trade of such medicinal products which are recognised as narcotic analgesic agents by the State Agency of Medicines have been found;

23.2. take one of the decisions referred to in Sub-paragraph 21.8.1 or 21.8.3 of this Regulation, if the procedures for the trade of medicinal products conform to the requirements specified in laws and regulations.

[25 January 2011]

24. If an examination deed with the decision referred to in Sub-paragraph 21.8.4 of this Regulation has been received and the violations and deficiencies found during the examination have been eliminated, the head of a medical treatment institution or a social care institution is entitled to submit the application referred to in Paragraph 18 of this Regulation to the Inspectorate for a repeated examination. Copies of documents (by presenting originals) shall be submitted, if changes have been made therein.

[10 March 2009]

25. In order to repeatedly receive an examination deed, the head of a medical treatment institution or a social care institution shall submit the application referred to in Paragraph 18 of this Regulation at least 30 days before the end of the term of validity of the previous examination deed. Copies of documents (by presenting originals) shall be submitted, if changes have been made therein.

[10 March 2009]

26. [10 March 2009]

27. If changes have been made to the information provided for in the application referred to in Paragraph 18 of this Regulation and to the documents, the head of a medical treatment institution or a social care institution shall, within five working days, submit information to the Inspectorate on the changes which were made in accordance with Annex 2 to this Regulation.

[10 March 2009]

28. If it has been indicated in the information referred to in Paragraph 27 of this Regulation that changes have been made to the premises where the trade of medicinal products is carried out or the procedures for the trade of medicinal products have been changed, the Inspectorate shall perform an examination and draw up an examination deed in accordance with Paragraph 21 of this Regulation.

29. The Inspectorate shall include the following information on the medical treatment institutions and social care institutions which have received the examination deed referred to in Paragraphs 21, 23 and 28 of this Regulation on its website:

29.1. the name, address and telephone number of the medical treatment institution or the social care institution;

29.2. the decision indicated in the examination deed;

29.3. the time period until which the acquisition of medicinal products is allowed.

[10 March 2009]

30. Social care institutions and medical treatment institutions which do not have a closed type pharmacy where preparation of medicinal products is allowed are entitled to acquire only ready-made pharmaceutical forms.

31. Medical treatment institutions and social care institutions are entitled to receive medicinal products, if corroborative documents on the acquisition of medicinal products (bills of lading, bills, records) have been drawn up and at least the following information is indicated therein:

31.1. the date of supply of the medicinal product;

31.2. the name of the medicinal product, pharmaceutical form, strength and number and quantity of each supplied manufacturing batch of the medicinal products;

31.3. the name and address of the supplier (consignor) of the medicinal product;

31.4. the name and address of the manufacturer of the medicinal product;

31.5. the period of validity of the medicinal product;

31.6. the price for which the medicinal product was supplied.

32. If a medical treatment institution or a social care institution acquires medicinal products that are not included in the Medicinal Product Register of Latvia, a request, which has been approved by the head of the medical treatment institution or the social care institution and in which the necessity to acquire non-registered medicinal products has been justified in accordance with the criteria specified in the Pharmaceutical Law, shall be required in addition to the documents referred to in Paragraph 31 of this Regulation. In a social care institution, a prescription written out by a family doctor may also be the document which justifies the necessity to acquire non-registered medicinal products to a particular patient.

33. The responsible official shall ensure:

33.1. that requests and corroborative documents on the acquisition of the narcotic substances and narcotic medicinal products or the psychotropic substances and psychotropic medicinal products, as well as the acquisition of such medicinal products which have been recognised as narcotic analgesic agents by the State Agency of Medicines would be drawn up separately from requests and corroborative documents of other medicinal products. The quantity of narcotic medicinal products shall be written in numbers and words;

33.2. that corroborative documents on the acquisition and registration of narcotic and psychotropic substances and medicinal products would be kept separately from requests and corroborative documents of other medicinal products.

[25 January 2011]

34. Only such persons are entitled to receive the narcotic substances and narcotic medicinal products or the psychotropic substances and psychotropic medicinal products from a pharmacy or a drug wholesaler who have been specified by the head of a medical treatment institution or a social care institution in accordance with the procedures referred to in Paragraph 2 of this Regulation.

[25 January 2011]

35. Documentation on the acquisition of narcotic substances and medicinal products shall be kept for at least 10 years, documentation on the acquisition of psychotropic substances and medicinal products and the acquisition of such medicinal products which have been recognised as narcotic analgesic agents by the State Agency of Medicines - for at least five years.

[25 January 2011]

36. If computer programs are used for the storage of information, they shall indicate the information in accordance with Paragraph 31 of this Regulation, as well as provide the possibility to print out the information required (also on the trade of medicinal products, registration and disposal of psychotropic substances and medicinal products and the state of stocks of medicinal products).

[25 January 2011]

37. A social care institution or a medical treatment institution which does not have a closed type pharmacy shall acquire stocks of medicinal products in such amount that does not exceed the amount necessary for the consumption of one month.

38. A medical treatment institution or a social care institution shall receive free samples of medicinal products in accordance with the procedures specified in the laws and regulations regarding the advertising of medicinal products, and gifts of medicinal products - in accordance with the procedures specified in the laws and regulations regarding the distribution of medicinal products.

39. A medical treatment institution or a social care institution shall be allowed to acquire only those medicinal products which are necessary for ensuring its operation. The head of the medical treatment institution and the social care institution, the responsible official, a member of the drug committee or a medical practitioner shall be liable for the acceptance of material values or taking of a benefit of a different nature, which is related to the acquisition of medicinal products or other activities related to the trade of medicinal products, in accordance with the Criminal Law.

III. Storage of Medicinal Products

40. In a medical treatment institution which has a closed type pharmacy medicinal products shall be stored in the closed type pharmacy until its distribution to units of the medical treatment institution.

41. In an inpatient medical treatment institution which does not have a closed type pharmacy medicinal products shall be stored in a separate room until its distribution to units. In other medical treatment institutions or social care institutions storage of medicinal products shall also be permitted in the cabinet of the responsible official.

42. The psychotropic substances and medicinal products and medicinal products which have been recognised as narcotic analgesic agents by the State Agency of Medicines shall be stored in lockable cupboards, separate from other medicinal products.

[25 January 2011]

43. The narcotic substances and narcotic medicinal products shall be stored in a safe or in a metal locker, which (if necessary) shall be fastened to a wall or the floor. The safe or metal locker shall be equipped with a sound or light alarm. During the absence of personnel, the safe or metal locker shall be locked and obligatory connected to the alarm system.

[25 January 2011]

44. The head of a closed type pharmacy and the responsible official shall ensure that:

44.1. medicinal products are stored pursuant to this Regulation, the laws and regulations regarding the distribution of medicinal products, as well as information indicated in the regulatory technical documentation in order to ensure preservation of the quality, efficacy and safety of medicinal products throughout the validity period thereof;

44.2. the temperature regimen in premises or equipment where medicinal products are stored conforms to the requirements specified on the labelling of the medicinal product and the requirements specified in the instruction for use;

44.3. unauthorised persons cannot access the room.

45. Medical treatment institutions and social care institutions shall store medicinal products in units for not more than five days of consumption. Medicinal products shall be stored in accordance with the procedures specified in Paragraphs 42, 43 and 44 of this Regulation.

[10 March 2009]

46. Medicinal products, which have been repealed or withdrawn from the market, medicinal products to which deficiencies have been detected in accordance with the laws and regulations regarding the distribution of medicinal products, medicinal products the validity period of which has expired, medicinal products of the quality of which doubts or suspicions have arisen (hereinafter - the poor quality medicinal products) shall be stored in a separate room, a demarcated location or in a packaging in order to prevent or reduce any possible risk to mix them with the good quality medicinal products. Poor quality narcotic substances and narcotic medicinal products or psychotropic substances and psychotropic medicinal products and unused narcotic substances and narcotic medicinal products which have been returned by patients shall be stored in accordance with the requirements specified in Paragraphs 42 and 43 of this Regulation.

[25 January 2011]

IV. Use of Medicinal Products

47. Units of a medical treatment institution and a social care institution shall receive medicinal products from a closed type pharmacy or the responsible official in accordance with the procedures referred to in Paragraph 2 of this Regulation.

48. Medicinal products shall be used on the basis of an entry of a medical practitioner in the medical history or an outpatient medical card.

49. A medical practitioner shall make an entry in the medical history or the outpatient medical card on the use of the narcotic substances and narcotic medicinal products, psychotropic substances and psychotropic medicinal products and such medicinal products which have been recognised as narcotic analgesic agents by the State Agency of Medicines by specifying the name, dosage, strength of the used medicinal products and the time of their use.

[25 January 2011]

50. A medical practitioner shall ensure that a patient or members of his or her family, or if there are no members of the family - closest relatives or legal representatives (trustees, guardians), or the responsible official of the social institution return unused narcotic substances and narcotic medicinal products to the medical treatment institution. The unused narcotic substances and narcotic medicinal products returned to the medical treatment institution shall be registered in the Register of Poor Quality and Returned Narcotic Medicinal Products (Annex 3). Pages of the Register shall be numbered and bound together. The Register shall be approved with the seal of the medical treatment institution and with the signature of the head thereof.

[25 January 2011]

51. The use of medicinal products shall be permitted only to ensure medical treatment at a medical treatment institution and a social care institution. Patients shall acquire the medicinal products necessary for outpatient medical treatment at a general type pharmacy. Prescription medicinal products shall be acquired on prescription, which has been written out in accordance with the procedures specified in the laws and regulations regarding the writing out of prescriptions. If delay of medical treatment may cause irrevocable consequences to the health of a patient or threaten the life of a patient, the medical practitioner may issue medicinal products to the patient for outpatient medical treatment in such amount, which ensures the treatment process until the patient is able to acquire the medicinal products at a pharmacy.

52. The responsible official of a medical treatment institution or a social care institution shall ensure:

52.1. issuing of instructions on the use of the medicinal products prescribed to a patient upon the request of the patient and accurate information on the use of medicinal products;

52.2. as quick identification and withdrawal of poor quality medicinal products from trade as possible;

52.3. disposal of the poor quality medicinal products or transfer thereof for disposal in accordance with the laws and regulations regarding hazardous waste.

53. Units of a medical treatment institution and a social care institution shall once a month submit information on the use of medicinal products to the responsible official in accordance with the procedures referred to in Paragraph 2 of this Regulation.

V. Registration of the Narcotic Substances and Narcotic Medicinal Products or the Psychotropic Substances and Psychotropic Medicinal Products

[25 January 2011]

54. Data on the trade and disposal of the narcotic substances and narcotic medicinal products shall be registered in the Strict Accountability Register of Narcotic Substances and Narcotic Medicinal Products (hereinafter - the Strict Accountability Register) (Annex 4) within one working day. Pages of the Strict Accountability Register shall be numbered and bound together. The Strict Accountability Register shall be approved with the seal of the medical treatment institution or the social care institution, the signature of the head and responsible official thereof. Date of the first and the last entry shall be indicated on the last page of the Register.

[25 January 2011]

55. Medicinal products, which in pure form or in a mixture with indifferent substances contain the following psychotropic substances and psychotropic medicinal products, shall also be registered in the Strict Accountability Register:

55.1. ephedrine;

55.2. pseudoephedrine;

55.3. phenobarbital;

55.4. trihexiphenidil;

55.5. GHB (sodium oxybutyrate).

[25 January 2011]

56. Entries in the Strict Accountability Register shall be made in accordance with the procedures specified in Paragraph 2 of this Regulation. If an entry is incorrect, it shall be deleted so that the initial content thereof remains visible, then the correct entry shall be made next to it by indicating the date when the correction was made, and the entry shall be confirmed by a signature and a personal stamp (if any).

57. Data on the handling and disposal of the psychotropic substances and psychotropic medicinal products (except for the medicinal products referred to in Paragraph 55 of this Regulation) and such medicinal products which have been recognised as narcotic analgesic agents by the State Agency of Medicines shall be registered in the Strict Accountability Register or using electronic, photo or another data processing system. A medical treatment institution or a social care institution shall ensure the storage of data for at least five years, as well as data extract upon the request of the Inspectorate. The extract shall be dated and confirmed by the signature and personal stamp (if any) of the responsible official.

[25 January 2011]

58. The responsible official shall examine the registration of narcotic substances and narcotic medicinal products, psychotropic substances and psychotropic medicinal products and such medicinal products which have been recognised as narcotic analgesic agents by the State Agency of Medicines once a month:

58.1. compare the remainder of medicinal products registered in the Strict Accountability Register with the actual remainder of medicinal products and enter results of the examination in the Strict Accountability Register, indicate the date of examination and confirm the entry with the signature and personal stamp (if any);

58.2. if the psychotropic substances and psychotropic medicinal products and such medicinal products, which have been recognised as narcotic analgesic agents by the State Agency of Medicines, are registered using electronic, photo or another data processing system, data on the relevant period of time shall be extracted and the registered remainder of substances and medicinal products shall be compared with the actual remainder of substances and medicinal product. The extract shall be dated, and the responsible official shall confirm it with the signature and personal stamp (if any).

[25 January 2011]

59. The Strict Accountability Register (after making of the last entry) and the data extracts referred to in Sub-paragraph 58.2 of this Regulation shall be stored for 10 years.

60. In performing examination, the Inspectorate shall indicate the date of examination of the last page of the Strict Accountability Register of Medicinal Products; the official of the Inspectorate shall confirm it with a signature and personal stamp.

[10 March 2009]

VI. Disposal of Poor Quality Medicinal Products and Unused Narcotic Substances and Narcotic Medicinal Products

[10 March 2009; 25 January 2011]

61. Poor quality medicinal products, which are not returned to the supplier, as well as unused narcotic substances and narcotic medicinal products returned by patients shall be disposed of in the presence of a commission established upon the order of the head of a medical treatment institution or a social care institution in accordance with the requirements of the laws and regulations regarding waste management or shall enter into a contract for waste management with a person who manages hazardous waste and has received a corresponding permit.

[25 January 2011]

62. A deed shall be drawn up on the disposal of or transfer of poor quality medicinal products and unused narcotic substances and narcotic medicinal products returned by patients to a person with whom a contract for the management of hazardous waste has been entered into. The name, serial number, quantity, strength, reason of disposal of the medicinal products, the given name, surname and position of the members of the commission shall be indicated in the deed. The deed on the disposal of the narcotic substances and narcotic medicinal products or the psychotropic substances and psychotropic medicinal products shall be compiled in two copies, one copy shall be sent to the Inspectorate within three days. If poor quality narcotic substances and narcotic medicinal products or psychotropic substances and psychotropic medicinal products are disposed of, data on the disposal of medicinal products shall also be registered in the corresponding accounting system, data on the disposal of poor quality and returned narcotic substances and narcotic medicinal products shall be registered in the Register of Narcotic Medicinal Products (Annex 3). The deed shall be kept for 10 years.

[25 January 2011]

VII. Shortage or Surplus, Theft, Robbery of Medicinal Products and Losses Thereof in Natural Disasters

63. If a shortage or surplus of medicinal products is detected, theft or robbery has taken place, or losses have occurred due to a natural disaster, the safe and room shall be sealed and ensured against the entrance of unauthorised persons. The head of a medical treatment institution or a social care institution shall notify of such fact:

63.1. the Inspectorate;

63.2 the State Police (if a shortage or surplus of medicinal products has been detected, a theft or robbery has taken place).

64. After determining the facts referred to in Paragraph 63 of this Regulation, the head of a medical treatment institution or a social care institution shall establish a commission upon an order, which shall consist of:

64.1. the head of the medical treatment institution or the social care institution or his or her authorised official;

64.2. the responsible official;

64.3. a representative of the State Police (if a shortage or surplus of medicinal products has been established, a theft or robbery has taken place).

65. The commission referred to in Paragraph 64 of this Regulation shall compile a deed. The reason of shortage or surplus of medicinal products, the name of medicinal products, pharmaceutical form and strength, serial number and quantity of medicinal products, the given name, surname and position of the members of the commission shall be indicated in the deed. All members of the commission shall sign the deed. The deed shall be kept for five years.

66. Shortage or surplus, theft or robbery of narcotic substances and narcotic medicinal products, as well as losses thereof due to a natural disaster shall also be registered in the Strict Accountability Register. Shortage or surplus of psychotropic substances and psychotropic medicinal products and such medicinal products, which have been recognised as narcotic analgesic agents by the State Agency of Medicines, as well as theft or robbery, or losses due to a natural disaster shall be registered in accordance with the procedures referred to in Paragraph 57 of this Regulation.

[25 January 2011]

VIII. Obligations of a Medical Treatment Institution or Social Care Institution

67. If a medical treatment institution or a social care institution ends its operation, is reorganised or liquidated, the person who is responsible for the reorganisation or liquidation shall submit information on the use, distribution or disposal of the remaining medicinal product stocks to the Inspectorate by specifying the legal persons to whom medicinal products have been distributed, or information on the disposal of medicinal products and a confirmation that the medicinal product stocks have been liquidated.

68. A medical treatment institution or a social care institution shall, within 15 days after the end of each quarter, submit a report in electronic form to the State Agency of Medicines on the use of narcotic and psychotropic substances and medicinal products, as well as use of such medicinal products which have been recognised as narcotic analgesic agents by the State Agency of Medicines, acquired during the reporting period (Annex 5). Inpatient medical treatment institutions shall, within a month after the end of each six-month period, provide a report to the National Health Service in electronic form on the use of all medicinal products received in the medical treatment institution (Annex 6).

[10 March 2009; 31 August 2010; 25 January 2011; 4 December 2012]

69. The State Agency of Medicines shall use the data provided by medical treatment institutions and social care institutions referred to in Paragraph 68 of this Regulation for the analysis and supervision of the consumption of narcotic and psychotropic substances and medicinal products, as well as the analysis and supervision of such medicinal products, which have been recognised as narcotic analgesic agents by the State Agency of Medicines. The National Health Service shall use the data of the reports specified in Paragraph 68 of this Regulation for the fulfilment of the tasks referred to in Paragraph 5 of this Regulation. If during the course of analysis suspicions arise to competent authorities referred to in this Paragraph of illegal trade of medicinal products, they shall inform the Health Inspectorate.

[10 March 2009; 31 August 2010; 25 January 2011; 4 December 2012]

IX. Closing Provisions

70. Cabinet Regulation No. 333 of 28 September 1999, Procedures for Acquisition, Storage, Use and Registration of Medicinal Products in Medical Treatment Institutions and Social Care Institutions (Latvijas Vēstnesis, 1999, No. 322/324; 2002, No. 109; 2003, No. 167), is repealed.

71. Medical treatment institutions and social care institutions that have received permits issued by the Ministry of Health for the acquisition of medicinal products shall be allowed to acquire medicinal products (including narcotic and psychotropic substances and medicinal products if it has been specified in the permit) at a drug wholesaler or a pharmacy until the end of the term indicated in the permit.

[25 January 2011]

72. The head of an inpatient medical treatment institution shall ensure updating of the list of medicinal products to be used and the development of a list of medicinal products to be additionally used for the particular therapeutic group pursuant to the terms of implementation specified in Annex 1 to this Regulation.

73. Doctor's practices may submit the information referred to in Paragraph 68 of this Regulation until 31 December 2007 also in paper form.

Acting for the Prime Minister, Minister for Defence A. Slakteris

Minister for Health V. Veldre

Annex 1
Cabinet Regulation No. 220
27 March 2007

Time Period for the Development and Introduction of the List of Medicinal Products to be Used and Medicinal Products to be Additionally Used for the Provision of Inpatient Health Care Services

Minister for Health V. Veldre

Annex 2
Cabinet Regulation No. 220
27 March 2007

Sample Application Form

[8 April 2008; 25 January 2011]

1. I request for the Health Inspectorate to perform (mark the appropriate with an x):

examination of the trade of medicinal products, including:

examination of the trade of the psychotropic substances and psychotropic medicinal products;

examination of the trade of the narcotic substances and narcotic medicinal products.

examination of the handling of medicinal products in relation to the end of the period of validity of the examination deed, including:

examination of the trade of the psychotropic substances and psychotropic medicinal products;

examination of the trade of the narcotic substances and narcotic medicinal products.

re-examination of the trade of medicinal products (after elimination of the violations and deficiencies detected during examination), including:

examination of the trade of the psychotropic substances and psychotropic medicinal products;

examination of the trade of the narcotic substances and narcotic medicinal products.

2. I inform the Health Inspectorate (mark the appropriate with an x):

about the changes in the submitted information;

that I submit documents, in which changes have been made.

5. The following copies of documents are appended to the application (mark the appropriate with an x):

a copy of a document confirming that the medical treatment institution conforms to the requirements specified in the laws and regulations regarding mandatory requirements for medical treatment institutions, on ___ pages

a copy of a document confirming that the social care institution conforms to the requirements specified in the laws and regulations regarding requirements for social care institutions, on ___ pages

the document regarding appointing of the responsible officials on ___ pages

documents confirming education of the responsible officials on ___ pages

the list of medicinal products to be used in the medical treatment institution or the social care institution on ___ pages

the list of medicinal products to be additionally used in the medical treatment institution or the social care institution on ___ pages

Head of the medical treatment institution or the social care institution

Place for a seal

Minister for Health V. Veldre

Annex 3
Cabinet Regulation No. 220
27 March 2007

Register of Poor Quality and Returned Narcotic Substances and Narcotic Medicinal Products

[25 January 2011]

Note. Strength - depending on the form of the medicinal product, a quantified expression of the content of the active substance in a unit of dosage, volume or weight.

Place for a seal

Minister for Health V. Veldre

Annex 4
Cabinet Regulation No. 220
27 March 2007

Strict Accountability Register of the Narcotic Substances and Narcotic Medicinal Products

[25 January 2011]

Place for a seal

Minister for Health V. Veldre

Annex 5
Cabinet Regulation No. 220
27 March 2007

[10 March 2009]

Report on the Use of Acquired Narcotic, Psychotropic Medicinal Products and Narcotic Analgesic Agents

Annex 6
Cabinet Regulation No. 220
27 March 2007

[10 March 2009]

Report on the Used Medicinal Products

Translation © 2018 Valsts valodas centrs (State Language Centre)