The Saeima ¹ has adopted and
President has proclaimed the following law:

Pharmaceutical Law

Chapter I
General Provisions

Section 1. (1) The following terms are used in this Law:

1) means of medical treatment - medicinal products, medical devices, and in vitro diagnostic medical devices;

1¹) active substance - any substance or mixture of substances intended to be used in the manufacture of medicinal products and production of medicinal products in a pharmacy and that, when used in manufacture or production of medicinal products, becomes an active ingredient of such medicinal products, which is intended to exert pharmacological, immunological or metabolic action with a view of restoring, correcting or modifying physiological functions or to make a medical diagnosis;

2) non-prescription medicinal products - medicinal products the pharmacological properties, strength, amount in packaging, method of administration and the possible adverse reaction caused by use of which shall not cause a direct or indirect threat to the health of the patient if they are used in accordance with instructions. In a pharmacy outpatient medical treatment medicinal products shall be issued without a prescription;

3) pharmacist's practice - pharmaceutical activities that are performed by a pharmacist individually or together with pharmacy employees in order to ensure pharmaceutical care in a pharmacy or medical treatment institution that is equipped and licensed in accordance with the procedures laid down by law;

4) pharmaceutical care - a component of health care, which is carried out by a pharmacist within the scope of his or her competence by providing pharmaco-therapeutic consultations, information concerning medicinal products and their use. Within such care is also included supervision of the use of medicinal products by permanent customers, medicinal product and other health care, prophylaxis and promotion of product distribution, preparation of medicinal products, promotion of health and disease prophylaxis popularisation on the basis of the latest scientific achievements and taking into account the interests of the customer, as well as ensuring customer data protection within the scope of his or her competence;

5) pharmaceutical and veterinary pharmaceutical activity - a form of commercial activity in the field of pharmaceuticals which is related to the preparation of medicinal products, manufacture, standardisation, quality control, importing, and distribution of medicinal products or active substances, and for the conduct of which the special permit (licence) specified in this Law or registration is required;

5¹) subject of pharmaceutical and veterinary pharmaceutical activity - a merchant or an undertaking owned by a merchant that on the basis of the special permit (licence) or registration is engaged in the preparation of medicinal products, manufacture, standardisation, quality control, importing, or distribution of medicinal products or active substances;

5²) pharmacovigilance - supervision of safe use of medicinal products;

6) pharmacy - research, preparation, manufacture, standardisation, quality control and distribution of medicinal products;

7) homeopathic medicinal products - medicinal products which are prepared from homeopathic stocks (products, substances or compounds) in accordance with homeopathic medicinal product manufacturing procedures, which are described in the European Pharmacopoeia or if they are not described in the European Pharmacopoeia in pharmacopoeia, which are officially used in European Union Member States. Homeopathic medicinal products may contain a number of principles;

7¹) importing - bringing of medicinal products and active substances in the customs territory of the European Union from countries or territories which are not European Union Member States or countries of the European Economic Area;

8) distribution - purchase, storage, supply, movement across the State border (bringing in, taking out), sale or transfer for use for a charge or free of charge of medicinal products;

9) quality - an indicator of the effectiveness of a medicinal product, which is dependent on the ingredients and on the specific method of manufacturing, and which is determined when evaluating the safety, efficacy, purity, quantitative and qualitative composition, physical, chemical, biological and therapeutical properties and conformity with technical standards documentation or pharmacopoeia requirements of the medicinal product;

10) quality control - examination of medicinal product quality parameters (testing), determining its conformity with technical standards documentation or pharmacopoeia requirements;

11) medicaments - medicinal products, which are prepared for a specific route of administration in a specific form and which are distributed with a specific name in a specific packaging;

12) medicinal products derived from human blood or human plasma - industrially prepared medicinal products, also medicinal products the basis of which are blood components, which contain proteins (albumins), blood coagulating factors and immunoglobulins (except for blood, plasma or blood cells);

12¹) practicing veterinarian - a person who has acquired the right to be engaged in veterinary medicinal practice and is dealing with it;

12²) excipient - any constituent of medicinal products, other than the active substance or the packaging material;

13) prescription medicinal products - medicinal products the pharmacological properties, strength, amount in packaging, method of administration and the possible adverse reaction caused by use without medical supervision of which may cause a direct or indirect threat to the health of the patient. In a pharmacy outpatient medical treatment medicinal products shall be issued only on the basis of a prescription;

13¹) radiopharmaceutical kit - any preparation that is to be prepared for use or combined with radionuclides in the final radiopharmaceutical (usually prior to the use thereof) (hereinafter - the kit);

13²) radiopharmaceutical - any medicinal product used in radiology that, in its form prepared for use, contains one or more radionuclides, i.e. radioactive isotopes, which are intended for medical purposes, except for isotopes from sealed sources;

13³) radionuclide generator - any system that contains a specific parent radionuclide, except for isotopes from sealed sources, from which a daughter radionuclide is produced by elution or another method, and which is used in radiopharmaceuticals;

13⁴) radionuclide precursors - radionuclides, except for isotopes from sealed sources, that are produced for radiolabelling of another substance prior to the use thereof;

13⁵) wholesale - activities that include the acquisition, storage, supply, including to another European Union Member State or a country of the European Economic Area, or export of medicinal products (bringing out of medicinal products from the customs territory of a European Union Member State to third countries), also when such activities take place in free zones, free ports, special economic areas, customs warehouses, facilities for temporary storage of goods, and other places indicated or approved by the customs service, except for the supply of medicinal products to the general population;

14) [20 June 2024];

15) [15 December 2005];

16) substance - any matter irrespective of origin (human origin, for example, human blood or human blood products; animal origin, for example, micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; plant origin, for example, micro-organisms, plants, parts of plants, plant secretions, extracts; chemical substances, for example, chemical elements, chemical substances naturally occurring or obtained by chemical change or synthesis);

16¹) falsified medicinal products - any medicinal product with a false representation of its identity (including its packaging and labelling), its name or its composition as regards any of the ingredients (including excipients and the strength of those ingredients), its source (including its manufacturer, its country of manufacturing, its country of origin and its marketing authorisation holder) and its history (including the records and documents relating to the distribution channels used);

17) medicinal products - any substance or combination of substances, which presents properties that are needed in order to provide medical treatment for human and animal diseases, or to perform prophylaxis of such diseases, as well as any substance or combination of substances, which may be utilised or administered to humans or animals with the aim of either to restore, correct or change physiological functions causing pharmacological, immunological or metabolic effects or to make a medical diagnosis;

18) [20 April 2023];

19) instructions on the use of medicinal products (hereinafter - the instructions for use (package leaflet)) - information provided for the user, which are added to medicinal products;

19¹) adverse reactions caused by the use of medicinal products - harmful and undesirable reaction of the human body caused by the use of medicinal products;

20) [20 April 2023];

21) manufacturing of medicinal products - the purchase of materials and products, manufacturing process, quality control, release, storage and distribution activities and control associated with them.

(2) The terms "non-interventional study", "good clinical practice", "low-intervention clinical trial", "auxiliary medicinal products", "subject", and "investigational medicinal products" used in this Law are used within the meaning of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (hereinafter - Regulation No 536/2014).

(3) The term "clinical trial of medicinal products" used in this Law corresponds to the term "clinical trial", "protocol of a clinical trial of medicinal products" - to the term "protocol", "sponsor of a clinical trial of medicinal products" - to the term "sponsor", "ethics committee of clinical studies of medicinal products" - to the term "ethics committee", "clinical study of medicinal products" - to the term "clinical study" within the meaning of Regulation No 536/2014.

(4) The term "clinical investigation of medicinal products" used in this Law corresponds to the term "clinical trial" used in Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (hereinafter - Regulation No 2019/6).

(5) The term "active substances" used in this Law in respect of raw materials of veterinary medicinal products and also the terms "veterinary medicinal products" and "wholesale" in respect of veterinary medicinal products are used within the meaning of Regulation No 2019/6.

(6) The term "advanced therapy medicinal products" used in this Law corresponds to the terms "advanced therapy medicinal products" and "combined advanced therapy medicinal products" used in Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

(7) The terms "medical device" and "in vitro diagnostic medical device" used in this Law are used within the meaning of the Medical Treatment Law and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter - Regulation No 2017/745), and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (hereinafter - Regulation No 2017/746).

(8) The term "medicinal products for compassionate use" used in this Law is used within the meaning of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter - Regulation No 726/2004).

[16 April 2003; 15 December 2003; 24 April 2008; 28 October 2010; 29 November 2012; 20 April 2023; 20 June 2024]

Section 2. The purpose of this Law is to regulate the activities of natural and legal persons and also of the National Armed Forces in the field of pharmaceuticals and also to ensure the manufacture and distribution of medicinal products which are qualitative, medically appropriate, and of an appropriate prophylactic, treatment, and diagnostic level, in the interest of patients.

[16 April 2003; 9 December 2021; 20 June 2024]

Chapter II
Competence of State Institutions Regarding Supervision and Control of Pharmacy

Section 3. The Ministry of Health shall be responsible for the supervision and control of the pharmacy system in the Republic of Latvia in the field of medicinal products for human use, but in the field of veterinary medicinal products the Ministry of Agriculture shall be responsible for it.

[28 October 2010]

Section 4. (1) Supervision and control of the manufacture of medicinal products and the distribution of medicinal products to wholesalers and pharmacies shall be conducted by the Health Inspectorate of Latvia.

(2) The Food and Veterinary Service shall supervise and control the manufacture and distribution of veterinary medicinal products as well as the use of medicinal products for human use on animals.

[15 December 2005; 27 September 2007; 28 October 2010]

Section 5. The Cabinet shall determine:

1) the conditions and procedures for issuing, suspending, renewing, re-registering, and revoking special permits (licences) for veterinary pharmaceutical activities, professional qualification certificates for pharmacists, the procedures for commencing operating and operating of pharmacies, and also the procedures for commencing operating and operating of veterinary medicinal product wholesalers and manufacturing or importing, operating, and conformity assessment of veterinary medicinal products;

1¹) the regulations regarding the licensing of pharmaceutical activities;

2) and shall approve, according to a recommendation from the Ministry of Health, a list of those medicinal product quality control institutions which are entitled to give an official opinion regarding the results of the quality control of medicinal products, including also medicinal products derived from human blood or human plasma and homeopathic medicinal products;

3) the procedures for manufacturing, labelling, registering, control, distributing, bringing in, and taking out medicinal products;

4) the principles for the pricing of medicinal products (except veterinary medicinal products);

5) the procedures for advertising medicinal products;

6) the procedures for conducting clinical investigation of medicinal products, and also the procedures for the monitoring of adverse reactions caused by the use of veterinary medicinal products;

7) the procedures for purchasing, storing and using medicinal products by medical treatment institutions and social care institutions;

8) the procedures for determining the minimum assortment of medicinal products for general (open) type pharmacies;

9) [19 March 1998];

10) the classification of medicinal products;

11) the restrictions on the use of medicinal products for animals;

12) the requirements to be met for instructions for use (package leaflet) of medicinal products;

13) the procedures for issuing certificates of good manufacturing practice to medicinal product manufacturers;

14) the procedures for evaluating conformity of distribution of medicinal products (except veterinary medicinal products) with the requirements of good distribution practices;

15) the requirements and procedures for clinical studies of medicinal products, including clinical trials of medicinal products and low-intervention clinical trials, and also non-interventional studies, and the supervision of such studies, including inspections of good clinical practice;

16) the criteria for the location of pharmacies and pharmacy branches (except veterinary pharmacies);

17) the procedures for registering pharmacists and pharmacist's assistants;

18) the requirements and the procedures by which veterinary medical practice institutions purchase, store, record, use, and destroy medicinal products;

19) the amount of the State fee to be paid for the issuance and re-registration of the special permit (licence) for veterinary pharmaceutical activities and the procedures by which such will be collected;

19¹) the amount of the State fee to be paid for the issuance and re-registration of the special permit (licence) for pharmaceutical activities and the procedures by which such will be collected, and also the exemptions and reliefs from the State fee;

20) the procedures for compensating expenditures for the acquisition of medicinal products and medical devices intended for out-patient medical treatment;

21) the procedures for collecting and compiling the information and forming statistics in the field of trade of veterinary medicinal products;

22) for a person the requirements of professional qualification necessary for distribution of veterinary medicinal products, the procedures for evaluating qualifications and the procedures for issuing a certificate for the distribution of veterinary medicinal products, for extending the term of validity and revoking thereof, as well as the procedures for registering a certified person;

23) the requirements and procedures for importing and distributing active substances and the procedures for registering importers, manufacturers and distributors of active substances;

24) the procedures for pharmacovigilance;

25) the procedures for and amount of wholesale data necessary for analysis of availability of medicinal products;

26) the food products to be distributed in pharmacies;

27) the requirements to be brought forward for the staff of the ethics committee of clinical studies of medicinal products and the conditions for the functioning of the committee.

[19 March 1998; 1 June 2000; 14 June 2001; 16 April 2003; 15 December 2005; 23 October 2008; 1 December 2009; 28 October 2010; 29 November 2012; 9 December 2021; 20 April 2023; 20 June 2024]

Section 6. The Minister for Health shall, within the scope of his or her competence:

1) implement the policy of the Government in the field of pharmaceuticals, organise the preparation of draft laws and regulations, necessary for the regulation of pharmaceuticals, and the control of conformity with the requirements of the laws and regulations in force, and approve the systems of classification and coding of medicaments in the pharmaceutical sector;

2) [15 December 2005];

3) organise the attestation of inspectors of the Health Inspectorate of Latvia and co-ordinate the preparation of pharmaceutical specialists, issue permits for conducting the training process, for students of higher educational institutions or pupils of secondary specialised educational institutions, in pharmacies, medicinal product wholesalers and medicinal product manufacturing, based on recommendations from the higher or secondary specialised educational institutions;

4) regulate the conditions for the manufacture, storage, control and distribution of particular medicinal products or groups of medicinal products;

5) ensure that the special permits (licences) provided for in the regulations of the Cabinet are issued;

6) [2 January 2000 / See Transitional Provisions];

7) approve the staff of the ethics committee of clinical studies of medicinal products;

8) [15 December 2005];

9) [15 December 2005];

10) [15 December 2005].

[19 March 1998; 1 June 2000; 14 June 2001; 16 April 2003; 15 December 2005; 27 September 2007; 23 October 2008; 20 April 2023]

Section 6.¹ The Minister for Agriculture shall, within the scope of his or her competence, implement the State policy in the field of veterinary medicinal products, organise the development of draft laws and regulations governing the trade of medicinal products intended for animals and the control of implementation of laws and regulations.

[28 October 2010]

Section 7.

[15 December 2005]

Section 8.

[20 June 2024]

Section 9.

[15 December 2005]

Section 10. The State Agency of Medicines shall, within the framework of its competence, perform the following functions:

1) organise the collection of information regarding current issues in the field of quality control of medicinal products, and also the formation of medicinal product consumption statistics in the State using information provided by pharmacies, medicinal product wholesalers, medicinal product manufacturers, medicinal product importers, medical treatment institutions, and veterinary medical practice institutions, and the gathering and dissemination of such information;

1¹) provide information regarding wholesale data of medicinal products necessary for analysis of availability of medicinal products (except veterinary medicinal products) according to the international non-proprietary name of medicinal products;

1²) publish the maximum permissible prices of medicinal products in pharmacies on its website;

2) create and regularly update the Medicinal Product Register of Latvia, grant registration numbers and codes of medicinal products, develop and maintain a database for consumption statistics of medicinal products;

3) evaluate and register medicinal products;

4) perform the quality expert-examination of medicinal products, also upon request of the Health Inspectorate of Latvia;

5) ensure co-operation with the institutions of the European Union, competent authorities in other states and international organisations in the field of the evaluation, registration, quality expert-examination of medicinal products, clinical studies and pharmacovigilance, in the field of licensing and conformity assessment of pharmaceutical activity, in issues related to bringing in, taking out, transit and distribution of medicinal products, in the field of registering medical devices, clinical investigation and supervision of safe use, and also in the field of supervision of safe use and conformity assessment of human blood, tissues, cells and organs;

6) co-operate with the public organisations of doctors and pharmacists;

7) issue permits for the distribution of medicinal products in accordance with the procedures laid down in the laws and regulations regarding the distribution of medicinal products;

7¹) [20 June 2024 / See Paragraph 36 of Transitional Provisions];

8) prepare and submit to the Ministry of Health recommendations regarding the inclusion of laboratories, institutes and other institutions in the list of such institutions as are entitled to give official opinions on issues regarding the quality of medicinal and pharmaceutical products;

9) evaluate the clinical trial and take the decision on the authorisation, conditional authorisation, or refusal of authorisation of the clinical trial of medicinal products, and also monitor the conduct of the clinical trial, including perform inspections of compliance of the clinical trial of medicinal products with the requirements of good clinical practice in accordance with Article 8(1), Article 47, Article 78(1) and (2), and Article 79(1) and (2) of Regulation No 536/2014;

10) [1 December 2009];

11) [20 April 2023];

12) assess the conformity of the medicinal product wholesalers, manufacturers, and importers, verify the conformity of the qualification and experience of the responsible official with the requirements laid down in this Law and the laws and regulations regarding the manufacture and distribution of medicinal products, and issue and re-register special permits (licences) for relevant pharmaceutical activities;

12¹) assess the conformity of the manufacturers, including foreign manufacturers, and importers of medicinal products with the requirements of good manufacturing practice laid down in this Law and the laws and regulations regarding the manufacturing of medicinal products, and issue certificates of good manufacturing practice;

12²) assess the conformity of the manufacturers of active substances for medicinal products for human use with the requirements of good manufacturing practice laid down in Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines for good manufacturing practice for active substances for medicinal products for human use (hereinafter - Regulation No 1252/2014), this Law, and the laws and regulations regarding the manufacturing of medicinal products, and issue certificates of good manufacturing practice;

12³) assess the conformity of the importers and distributors of medicinal products and active substances for human use with the requirements of good distribution practice laid down in this Law and the laws and regulations regarding the distribution of medicinal products, and issue certificates of good distribution practice;

12⁴) assess the conformity of the manufacturers of active substances for medicinal products for human use with the requirements laid down in Regulation No 1252/2014 and this Law, and issue and re-register special permits (licenses) for the manufacturing of active substances for medicinal products for human use if such a special permit (license) is required for the manufacturer in relation to the bringing in and distribution of active substances, or registration of medicinal products in a third country;

12⁵) assess the manufacturer and importer of investigational medicinal products and verify the conformity of the qualification and experience of the qualified official with the requirements laid down in this Law, Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (hereinafter - Regulation No 2017/1569), and the laws and regulations regarding the manufacture of medicinal products, and issue and re-register special permits (licences) for the manufacture and importing of investigational medicinal products;

12⁶) assess the conformity of the manufacturers, including foreign manufacturers, and importers of investigational medicinal products with good manufacturing practice, the requirements laid down in Regulation No 2017/1569, this Law, and the laws and regulations regarding the manufacture of medicinal products, and issue certificates of good manufacturing practice;

12⁷) assess the conformity of the manufacturer of hospital exemptions specified in Section 20, Clause 7 of this Law and verify the conformity of the qualification and experience of the responsible official with the requirements laid down in this Law and the laws and regulations regarding the manufacture and control of medicinal products, and also issue and re-register the special permit (license) for the manufacturing of hospital exemptions;

12⁸) assess the conformity of the manufacturer of hospital exemptions specified in Section 20, Clause 7 of this Law with good manufacturing practice, the requirements laid down in this Law and the laws and regulations regarding the manufacture and control of medicinal products, and issue certificates of good manufacturing practice;

12⁹) evaluate the submissions for the conformity of the use of hospital exemptions specified in Section 20, Clause 7 of this Law with the requirements laid down in this Law and the laws and regulations regarding advanced therapy medicinal products, and issue or extend the permit for a hospital to use advanced therapy medicinal products in medical treatment if the decision has been taken to permit the use of such medicinal products in medical treatment;

12¹⁰) evaluate the submissions for the issuance and re-registration of the special permit (license) referred to in Section 25.⁵ of this Law for a customs warehouse with the permitted field of activity, i.e. receipt and storage of medicinal products, based on the inspection report of the Health Inspectorate regarding the conformity of the premises and equipment, including devices, and also the personnel, responsible official, and documentation, with the requirements laid down in this Law and the laws and regulations regarding the distribution of medicinal products, and issue and re-register the special permit (license) granted to the customs warehouse for the wholesale distribution of medicinal products which is issued to a medicinal product wholesaler and specifies the receipt and storage of medicinal products as the permitted field of activity;

13) determine whether a medicinal product belongs to non-prescription or prescription medicinal products in accordance with the procedures stipulated by the Cabinet;

14) issue permits for the clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices and also permits to place on the market or put into service medical devices and in vitro diagnostic medical devices that have not been subject to the conformity assessment procedures specified in the laws and regulations regarding medical devices and in vitro diagnostic medical devices and are not marked with the CE marking, and issue certificates of free sale, analyse serious incidents and field safety corrective actions within the scope of the vigilance system, and also maintain the database of medical devices of Latvia in accordance with Article 59(1), Article 60(1), Article 62(4)(a), and the first subparagraph of Article 89(3) and Article 89(4) of Regulation No 2017/745 and Article 54(1), Article 55(1), Article 58(5)(a), and the first subparagraph Article 84(3) and Article 84(4) of Regulation No 2017/746;

14¹) issue a single registration number (SRN) in the EUDAMED, European medical devices database, to manufacturers, authorised representatives, and importers of medical devices and in vitro diagnostic medical devices in accordance with Article 31(2) of Regulation No 2017/745 and Article 28(2) of Regulation No 2017/746;

14²) register the distributors of medical devices and in vitro diagnostic medical devices and collect information about the medical devices manufactured in medical institutions in accordance with the second subparagraph of Article 5(5) and Article 30(2) of Regulation No 2017/745 and the second subparagraph of Article 5(5) and Article 27(2) of Regulation No 2017/746;

14³) evaluate the information provided by the importers and distributors about the intention to make available on the Latvian market re-labelled or re-packaged medical devices and in vitro diagnostic medical devices in accordance with Article 16(4) of Regulation No 2017/745 and Article 16(4) of Regulation No 2017/746;

15) perform conformity assessment and supervision of centres for acquiring and storage of tissues, cells and organs, blood rooms of medical treatment institutions, blood preparation divisions and the State Blood Donor Centre;

16) evaluate the submissions for the issuance and re-registration of the special permit (license) for the operation of a general type pharmacy or operating of a closed type pharmacy with a certification (or, if necessary, an opinion issued by the Health Inspectorate) on the conformity of location, premises, and equipment, including devices, personnel, and documentation, with the criteria for the location of pharmacies and pharmacy branches (except for veterinary pharmacies), and the requirements for the distribution of medicinal products laid down in this Law and the laws and regulations regarding the operation of pharmacies, and also issue and re-register special permits (licenses);

17) assess submissions submitted in order to register manufacturers, importers and distributors of active substances, and register them in accordance with the procedures laid down in the laws and regulations regarding registration of manufacturers, of importers and distributors of active substances;

18) perform the functions of pharmacovigilance, including supervision of the adverse effects caused by the use of medicinal products, create and maintain a database in relation to supervision of safe use of medicinal products;

19) perform economic assessment of medical technologies paid for using funds from the State budget.

[19 March 1998; 1 June 2000; 14 June 2001; 16 April 2003; 15 December 2005; 27 September 2007; 23 October 2008; 1 December 2009; 28 October 2010; 29 November 2012; 11 April 2019; 9 December 2021; 20 April 2023; 20 June 2024 / Amendment regarding the new wording of Clause 7 and deletion of Clause 7.¹ shall come into force on 1 July 2025. See Paragraph 36 of Transitional Provisions]

Section 11. The National Health Centre shall perform the following functions within the scope of its competence:

1) [11 April 2019];

2) develop rational pharmacotherapy recommendations;

3) determine the prices of medicinal products and medical devices intended to be compensated in outpatient medical treatment and draw up a list of medicinal products and medical devices intended to be compensated in outpatient medical treatment;

4) perform the settlement of accounts with pharmacies for the issued medicinal products and medical devices within the scope of the procedures for compensating the expenses for the purchase of medicinal products and medical devices intended to be compensated in outpatient medical treatment;

5) draw up a list of medicinal products to be used in inpatient medical treatment institutions.

[29 November 2012; 11 April 2019]

Section 12. (1) The Food and Veterinary Service shall, within the competence thereof, conduct the following functions:

1) assess, classify and register veterinary medicinal products;

1¹) fulfil the obligations of the competent authority referred to in Article 137 of Regulation No 2019/6;

2) establish and update the Veterinary Medicinal Product Register of the Republic of Latvia, grant registration numbers and codes for veterinary medicinal products, establish and maintain a data base regarding observed adverse reactions caused by veterinary medicinal products, regarding clinical investigation of veterinary medicinal products and observations of use thereof;

3) organise collection of information, compile information, and form statistics in the field of trade of veterinary medicinal products using the information provided by veterinary medicinal product manufacturers, importers, distributors, practising veterinarians, and veterinary medical practice institutions;

4) ensure the quality control of veterinary medicinal products;

5) ensure the co-operation with competent institutions of other countries in the field of assessment, registration and control of veterinary medicinal products;

6) issue permits for bringing in, taking out, and distribution of veterinary medicinal products as well as of the veterinary medicinal products intended for clinical investigations, except for the permits for bringing in, taking out, and distribution of veterinary narcotic and psychotropic medicinal products;

7) issue permits for distribution of veterinary medicinal products for veterinary medicinal products other than registered in the Republic of Latvia if:

a) veterinary medicinal products are necessary for treatment of a particular animal, treatment of particular animal disease or performance of medical manipulations and the medicinal products included in the Veterinary Medicinal Product Register of Latvia may not be used due to medical indications - on the basis of a written request of a practicing veterinarian and, if necessary, of an opinion of the Latvian Association of Veterinarians;

b) veterinary medicinal products are necessary for provision of veterinary medical care in case of disaster, natural disaster or threats of spread of dangerous animal infectious diseases - on the basis of a decision of the State Chief Veterinary and Food Inspector;

8) prepare and approve the list of those institutions which are entitled to provide official opinion regarding quality issues of veterinary medicinal products;

9) assess the conformity of veterinary pharmacies, veterinary medicinal product wholesalers, manufacturers (also foreign manufacturers) and importers, check the conformity of the qualification and experience of the responsible official with the requirements laid down in laws and regulations, and issue special permits (licences) for veterinary pharmaceutical activities;

10) issue permits for the bringing into the Republic of Latvia of diagnostics for the needs of approbation and the acquiring, introduction and use of new methods;

11) assess the conformity of manufacturers and importers of veterinary medicinal products and active substances used as starting materials in veterinary medicinal products with the requirements of good manufacturing practice and issue certificates of good manufacturing practice for veterinary medicinal products;

12) assess the conformity of manufacturers, importers, and distributors of veterinary medicinal products and active substances used as starting materials in veterinary medicinal products with the requirements of good distribution practice and issue certificates of good distribution practice;

13) register the manufacturers, importers, and distributors of active substances used as starting materials in veterinary medicinal products, make changes in the register, and also delete them from the register.

(2) The Cabinet shall determine the types of paid services of the Food and Veterinary Service and the procedures for performance of payment for the activities provided for in this Law.

[28 October 2010; 29 November 2012; 9 December 2021; 5 October 2023; 20 June 2024]

Section 13.

[20 June 2024]

Section 14. Officials of the Health Inspectorate, but in respect of the trade of veterinary medicinal products the Food and Veterinary Service inspectors shall, within the scope of their competence, have the right to:

1) for the purpose of the supervision of pharmacy, supervise and control legal persons which are engaged in the activities with medicinal products and active substances, including pharmacies, medicinal product wholesalers, manufacturers and importers of medicinal products and active substances, medical treatment institutions, social care institutions, veterinary medical practice institutions, customs warehouses in which medicinal products and active substances are stored, and natural persons who work in the field of pharmaceuticals irrespective of their subordination, type and nature of the commercial activity, assess conformity of the distribution of medicinal products and active substances with the requirements of laws and regulations, and also give, within the scope of their competence, binding orders on pharmaceutical issues to the persons referred to in this Clause;

2) perform the evaluation of premises, equipment, personnel and documentation regarding conformity with the work to be performed and its volume;

3) control that the procedures provided for the reimbursement of expenditures for the acquisition of medicinal products and medical devices in outpatient medical treatment are complied with;

4) ensure co-operation with international organisations and the relevant institutions of other states;

5) make control purchases and in cases of doubt or suspicion, remove samples of medicinal products from pharmacies, medicinal product wholesalers, medicinal product manufacturers and importers and send them for quality control to medicinal product quality control institutions. If the medicinal products are not in conformity with the requirements of technical standards documentation or the pharmacopoeia, the expenditures for the quality control of the medicinal product samples shall be covered by the pharmaceutical or veterinary pharmaceutical entity. If the medicinal products conform to such requirements, the expenditures shall be covered from the resources of the authority which performed the control;

6) in accordance with laws and regulations, suspend the pharmaceutical or veterinary pharmaceutical activities of a legal or natural person or suspend distribution of products pending a final clarification of circumstances;

7) prohibit the distribution of any medicinal products, active substances, and excipients if such are determined to be of inferior quality or falsified, but in a case when doubts have arisen regarding their quality, suspend distribution of the relevant medicinal products, active substances or excipients pending a final clarification of their quality;

8) prohibit the manufacture, importing or distribution of medicinal products, withdraw and confiscate medicinal products, if their manufacture, importing or distribution is conducted in violation of the requirements laid down in the laws and regulations in the field of pharmacy;

9) propose that for the violation of pharmaceutical and veterinary pharmaceutical activities the special permit (licence) for pharmaceutical activities or the special permit (licence) for veterinary pharmaceutical activities, or permit for the acquisition of medicinal products be suspended or revoked;

10) monitor advertisements of medicinal products;

11) [21 May 2020].

[16 April 2003; 27 September 2007; 23 October 2008; 28 October 2010; 29 November 2012; 21 May 2020; 9 December 2021]

Section 14.¹ When monitoring good manufacturing practice and good distribution practice of medicinal products, veterinary medicinal products, and active substances, the competent authorities shall follow the compilation of procedures for European Union inspections and exchange of information published by the European Medicines Agency and approved by the European Commission.

[20 June 2024]

Section 15.

[24 April 2008]

Section 16.

[19 March 1998]

Chapter III
Medicinal and Pharmaceutical Products

Section 17. (1) Medicinal products may be placed on the market and distributed if they are registered in the Republic of Latvia and included in the Medicinal Product Register of Latvia in accordance with this Law, except for the cases referred to in Section 20 of this Law, or if the medicinal products are registered in the European Union in accordance with Regulation No 726/2004. Falsification of medicinal products, manufacturing and distribution of falsified medicinal products shall be prohibited.

(2) Unregistered medicinal products, including medicinal products for compassionate use, may be distributed if the permit for the distribution of unregistered medicinal products has been obtained from the State Agency of Medicines, except for the case referred to in Section 20 and Section 26.¹, Paragraph five of this Law, in accordance with the laws and regulations regarding the bringing in, bringing out, and distribution of medicinal products. The Cabinet shall determine the cases when the permit for distribution is not required for unregistered medicinal products, issue regulations regarding the issuance of the permit, and lay down the requirements for the bringing in and bringing out of unregistered medicinal products.

(3) Veterinary medicinal products may be placed on the market and distributed if they are registered in the Republic of Latvia or have obtained a marketing authorisation in accordance with Article 44 of Regulation No 2019/6 and are included in the database referred to in Article 55 of Regulation No 2019/6 and in the Veterinary Medicinal Product Register of Latvia, except for the cases referred to in Section 12, Clauses 7 and 10, and Section 20 of this Law.

(4) Paragraph one of this Section shall also apply to radionuclide generators, kits, radiopharmaceuticals of radionuclide precursors, and industrially produced radiopharmaceuticals.

(5) A licensed manufacturer and importer of medicinal products, a medicinal product wholesaler, and the person referred to in Section 25.¹ of this Law who has the special permit (license) issued in a European Union Member State or a country of the European Economic Area which gives the right to perform wholesale or manufacture of medicinal products, is entitled to bring in, supply, and bring out medicinal products and substances for the registration of medicinal products, including for the purpose of testing and for non-medical purposes, i.e. for research or development trials, including testing, and also for study purposes for higher education institutions (hereinafter - the samples of medicinal products and substances), in accordance with the laws and regulations regarding bringing in, bringing out, and distribution of medicinal products. The merchant shall not be required to obtain the permit referred to in Section 10, Clause 7 of this Law if the medicinal products are brought in, brought out, and distributed as samples. The Cabinet shall issue the regulations regarding the bringing in and circulation of the samples of medicinal products and substances.

[20 June 2024]

Section 18. Provisions regarding the manufacturing, storage, distribution, use, bringing in, and taking out of narcotic and psychotropic medicinal products and precursors shall be regulated by this Law and the Law on the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products, and also Precursors.

[9 December 2021]

Section 19. Procedures for the quality control of medicinal products shall be regulated by Cabinet regulations. The person whose activities are controlled, unless otherwise stipulated by Cabinet regulations shall cover the costs of control.

[16 April 2003]

Section 20. Registration of medicinal products and medicinal product substances shall not be required if:

1) the medicinal products are prepared at a pharmacy pursuant to a prescription, including a veterinary prescription, or upon written request of a medical treatment institution or a veterinary medical practice institution for a patient;

2) the medicinal products are intended for research or development trials, or clinical trials that are agreed upon with the State Agency of Medicines or, in respect of veterinary medicinal products, with the Food and Veterinary Service;

3) the substances are intended for the manufacturing of other medicinal products;

4) [2 January 2000 / See Transitional Provisions];

5) [2 January 2000 / See Transitional Provisions];

6) the medicinal products are prepared at a pharmacy according to the monograph of pharmacopoeia for an individual patient;

7) they are hospital exemptions to be used in a medical treatment institution which are manufactured on a non-routine basis according to the instructions of the attending physician and designated (prescribed) for a specific patient who uses them in a medical treatment institution of the Republic of Latvia which has the right to use hospital exemptions and to which an exception is applied in respect of the registration of such medicinal products (hereinafter - the hospital exemptions);

8) they are radiopharmaceuticals that are prepared in a medical treatment institution directly before use only from authorised radionuclide generators, kits, or radiopharmaceuticals of radionuclide precursors according to the instructions of manufacturers in a unit of the medical treatment institution that is authorised to handle activities involving sources of ionising radiation.

[1 June 2000; 16 April 2003; 15 December 2005; 23 October 2008; 28 October 2010; 9 December 2021; 20 June 2024]

Section 21. The distribution and use of medicinal products shall be prohibited, if their quality does not comply with the requirements set out in the documentation of approved technical standards (pharmacopoeia, technical regulations, documentation approved during the registration of medicinal products, and others), or their expiry date has passed.

[16 April 2003]

Section 21.¹ If veterinary medicinal products necessary for treatment and prophylaxis of animals are not available, a practicing veterinarian is allowed to distribute and use medicinal products for human use in accordance with the procedures laid down in laws and regulations.

[28 October 2010]

Section 22. (1) When medicinal products are distributed, they shall be accompanied by instructions for use (package leaflet), which conform to the requirements stipulated by the Cabinet.

(2) If medicinal products have been classified as prescription medicinal products, a pharmacy may dispense them only:

1) on the basis of a relevant prescription, including a veterinary prescription;

2) for a veterinary medical practice institution - upon written request of a practising veterinarian;

3) for a medical treatment institution and a social care institution - upon written request of the institution.

(2¹) Unregistered medicinal products may only be dispensed at a pharmacy on the basis of the prescription referred to in Paragraph two, Clauses 1, 2, and 3 of this Section or upon request of the institution. A patient shall use the unregistered medicinal products under the direct personal supervision of the medical practitioner who has designated (prescribed) the medicinal products and assumed responsibility for the selected treatment, or under the supervision of another medical practitioner who continues treatment of the patient.

(3) In the wholesaling of medicinal products and active substances, the good distribution principles and guidelines of medicinal products and active substances shall be ensured in accordance with the guidelines published by the European Commission and in accordance with the legislation of the European Union.

(4) The principles of good distribution practice shall be complied with in the wholesale of veterinary medicinal products and active substances used as starting materials in veterinary medicinal products in accordance with Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council and Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.

[19 March 1998; 1 June 2000; 16 April 2003; 15 December 2003; 23 October 2008; 28 October 2010; 29 November 2012; 9 December 2021; 5 October 2023; 20 June 2024]

Section 23. Only medicinal products intended for animals may be dispensed on the basis of the receipt of a prescription or request, which has been written by a practising veterinarian.

[23 October 2008]

Section 24.

[23 October 2008]

Section 25. (1) Preparation of medicinal products, manufacture, importation, and distribution of medicinal products in the Republic of Latvia shall only be permitted if the special permit (license) has been obtained for the relevant type of commercial activity, as specified in Sections 37 and 45, and also in Section 51, Paragraphs one and two of this Law.

(2) The manufacture and distribution of the hospital exemptions shall only be permitted if the special permit (license) has been obtained for the relevant type of activity, as specified in Article 51.³ of this Law.

[20 June 2024]

Section 25.¹ (1) A person who has a special permit (licence) issued in a Member State of the European Union or in a state of the European Economic Area, which gives the right to perform the wholesaling or manufacture of medicinal products, has a duty to provide the State Agency of Medicines or the Food and Veterinary Service - in respect of veterinary medicinal products - the information laid down in the laws and regulations regarding the distribution of medicinal products in respect of commencing medicinal product wholesaling in the Republic of Latvia. In such case, it is not necessary for the merchant to obtain the special permit (licence) determined in Section 25 of this Law.

(2) The information provided for in Paragraph one of this Section need not be provided on investigational medicinal products and auxiliary medicinal products.

[15 December 2005; 28 October 2010; 20 April 2023]

Section 25.² Recommendations (guidelines) of the European Commission which have been published in the volumes of the Rules Governing Medicinal Products in the European Community (Eudralex) shall be applied in preparing the documentation regarding pharmacovigilance in relation to the medicinal products for human use and adverse reactions caused by the use of veterinary medicinal products and the documentation pertaining to the manufacture, importing, and distribution of active substances, and also the manufacture of medicinal products, clinical trials of medicinal products or, in the case of veterinary medicinal products - clinical investigation of medicinal products, registration, classification, labelling, and instructions for the use of medicinal products.

[29 November 2012; 20 April 2023]

Section 25.³ Intermediary transactions involving medicinal products for human use are permitted if the person has registered with the State Agency of Medicines in accordance with the procedures laid down in the laws and regulations regarding distribution of medicinal products.

[29 November 2012]

Section 25.⁴ (1) A ship and the ship's agent specified in Section 112, Paragraph four of the Maritime Code (hereinafter - the ship's agent) may purchase medicinal products for the supply of the ship at a general type pharmacy, a medicinal product wholesaler, and directly from the manufacturer or importer of medicinal products. A ship may purchase medicinal products for the supply of the ship from the ship's agent.

(2) The ship's agent shall be required to obtain the permit for the distribution of medicinal products from the State Agency of Medicines in order to purchase medicinal products for the supply of the ship. The Cabinet shall issue the regulations regarding the issuance of the permit for the distribution of medicinal products to the ship's agent.

(3) The Cabinet shall issue the regulations regarding the distribution of medicinal products for the supply of the ship.

[20 June 2024]

Section 25.⁵ The provisions of Sections 25, 45, and 46.¹ of this Law shall apply to the place specified in the permit for the activity of a customs warehouse (customs warehouse) where medicinal products are stored for more than 72 hours, and the holder of the customs warehouse permit shall obtain, in accordance with the procedures laid down in the laws and regulations regarding the licensing of pharmaceutical activities, the special permit (license) referred to in Section 45, Paragraph one of this Law for the wholesale distribution of medicinal products which is issued to a medicinal product wholesaler and specifies the receipt and storage of medicinal products in a customs warehouse as the permitted field of activity.

[20 June 2024]

Section 25.⁶ In the case of a significant threat to the State, public, environment, or another threat, an international organisation or another foreign authority may, upon agreement with the Ministry of Health or, in respect of veterinary medicinal products, with the Ministry of Agriculture, supply medicinal products to Latvia. The provisions of Section 25 of this Law shall not be applicable to such medicinal products and it shall not be required to obtain the permit for the distribution of unregistered medicinal products and veterinary medicinal products specified in this Law. The Cabinet shall issue regulations regarding the distribution in Latvia of medicinal products received from an international organisation or foreign authority.

[20 June 2024]

Chapter IV
Clinical Studies of Medicinal Products, Evaluation and Registration of Medicinal Products

[20 April 2023]

Section 26. The evaluation, registration, re-registration and post-registration supervision of medicinal products shall be conducted by the State Agency of Medicines or the Food and Veterinary Service - in respect of veterinary medicinal products.

[15 December 2005; 28 October 2010]

Section 26.¹ (1) Clinical studies of medicinal products, including clinical trials of medicinal products and low-intervention clinical trials, shall take place in accordance with Regulation No 536/2014 and the laws and regulations regarding clinical studies of medicinal products.

(2) A clinical trial of medicinal products may be conducted if the sponsor of the clinical trial of medicinal products has obtained the authorisation of the State Agency of Medicines for conducting the clinical trial of medicinal products on the basis of the scientific and clinical evaluation of the clinical trial of medicinal products as set out in Article 6 of Regulation No 536/2014 and the evaluation by the ethics committee of clinical studies of medicinal products of the ethical aspects of the clinical trial of medicinal products and the aspects set out in Article 7 of this Regulation. The Cabinet shall determine the procedures and requirements according to which the State Agency of Medicines shall issue and revoke the abovementioned authorisation for conducting a clinical trial and shall suspend or renew a clinical trial.

(3) Good clinical practice shall be ensured in the clinical trial of medicinal products in accordance with Article 47 of Regulation No 536/2014 and Articles 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 of Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council.

(4) In a clinical trial of medicinal products, such investigational medicinal products and auxiliary medicinal products shall be used that correspond to the respective term "authorised investigational medicinal products" or "authorised auxiliary medicinal products" used in Regulation No 536/2014 and that are registered in accordance with Regulation No 726/2004 or with this Law, and the laws and regulations regarding the registration of medicinal products, irrespective of changes in the labelling of such medicinal products.

(5) If investigational medicinal products and auxiliary medicinal products not registered in accordance with Regulation No 726/2004, this Law and the laws and regulations regarding the registration of medicinal products are used in the clinical trial of medicinal products, the bringing in, distribution, and use of such medicinal products in the clinical trial of medicinal products shall be permitted where the use of such medicinal products is duly justified in the protocol of the clinical trial of medicinal products and the medicinal products correspond to the relevant term "unauthorised investigational medicinal product" or "unauthorised auxiliary medicinal product" as used in Regulation No 536/2014. In such case, it shall not be required to obtain the permit for the distribution of unregistered medicinal products specified in this Law for unregistered investigational medicinal products and auxiliary medicinal products.

[20 April 2023; 20 June 2024 / Amendment to Paragraph five regarding the replacement of the words and numbers "the permit for the distribution of medicinal products provided for in Section 10, Clauses 7 and 7.¹ of this Law" with the words "the permit for the distribution of unregistered medicinal products specified in this Law" shall come into force on 1 July 2025. See Paragraph 36 of Transitional Provisions]

Section 26.² (1) Non-interventional studies shall be conducted in accordance with the laws and regulations regarding clinical studies of medicinal products.

(2) A non-interventional study may be conducted if a positive opinion of the ethics committee of clinical studies of medicinal products has been received.

[20 April 2023]

Section 26.³ (1) The subject has the right to receive compensation for the harm inflicted on his or her health or life within the scope of a clinical trial of medicinal products and a low-intervention clinical trial in accordance with the laws and regulations regarding clinical studies of medicinal products.

(2) The sponsor of a clinical trial of medicinal products has an obligation to insure its civil liability and civil liability of the investigator for the harm inflicted on the health or life of a subject in a clinical trial of medicinal products.

(3) The medical treatment institution has an obligation to insure its civil liability and civil liability of the investigator for the harm inflicted on the health or life of a subject in a low-intervention clinical trial.

(4) Civil liability insurance shall cover the entire duration of the clinical trial of medicinal products and the low-intervention clinical trial. A civil liability insurance contract shall be concluded for each individual clinical trial of medicinal products and low-intervention clinical trial prior to the relevant trial. The Cabinet shall determine the procedures for civil liability insurance of the sponsor of a clinical trial of medicinal products and the medical treatment institution, the minimum limit of liability of the insurance contract, and the mandatory risks to be insured by the sponsor of a clinical trial of medicinal products and the medical treatment institution.

(5) The investigator or other persons involved in a clinical trial of medicinal products or a low-intervention clinical trial shall be liable in accordance with the laws and regulations of the Republic of Latvia for any harm inflicted on the health or life of the subject through non-compliance with the activities set out in the protocol of a clinical trial of medicinal products.

[20 April 2023 / See Paragraph 32 of Transitional Provisions]

Section 27.

[19 March 1998]

Section 28.

[15 December 2005]

Section 28.¹ (1) The submission and documentation for the registration, re-registration of medicinal products, and changes in the registration or registration conditions of medicinal products shall be submitted in accordance with the laws and regulations regarding the registration of medicinal products and veterinary medicinal products. The submissions for the registration, re-registration of medicinal products, and changes in the registration or registration conditions of medicinal products shall be submitted in the English language without translation into the official language, in a form of electronic submission via the Common European Submission Portal.

(2) The State Agency of Medicines and the Food and Veterinary Service shall accept and approve the submissions and documents referred to in Paragraph one of this Section if they are submitted and the identity of the submitter is verified using the online form available on the Common European Submission Portal. In such case, the submission and accompanying documents shall be accepted and examined in the English language.

[20 June 2024]

Section 28.² The submission documentation in relation to the clinical trial of medicinal products shall be submitted in accordance with Chapters II, III, IV, and VI of Regulation No 536/2014 and the laws and regulations regarding clinical studies of medicinal products through the European Union clinical trials portal set out in Article 80 of this Regulation, to the European Union database set out in Article 81 of Regulation No 536/2014. The documentation in Annex I to this Regulation may be submitted in English in accordance with the laws and regulations regarding clinical studies of medicinal products, except for the documents intended for the subject.

[20 April 2023]

Section 28.³ Information on adverse reactions to medicinal products shall be submitted in the electronic database and data processing network of the European Medicines Agency referred to in Article 24 of Regulation No 726/2004 (Eudravigilance database). Periodic safety update reports on medicinal products, including auxiliary medicinal products, shall be submitted through the repository of periodic safety update reports of the European Medicines Agency referred to in Article 25a of Regulation No 726/2004. Information on adverse reactions to investigational medicinal products and annual reports on the safety of investigational medicinal products shall be submitted through the electronic database of the European Medicines Agency referred to in Article 40(1) of Regulation No 536/2014.

[20 April 2023]

Section 29. (1) Expenses related to the evaluation, registration, re-registration, and post-registration supervision of medicinal products shall be covered by the applicant for registration and the expenses related to clinical trials of medicinal products shall be covered by the sponsor of the clinical trial of medicinal products in accordance with the Cabinet regulations regarding the price list of paid public services.

(2) Costs associated with evaluation, registration, re-registration and post-registration supervision of veterinary medicinal products shall be covered by the applicant for registration in accordance with the regulatory enactment regarding the procedures for payment of activities of the State supervision and control performed by and paid services provided by the Food and Veterinary Service.

(3) Expenses related to the evaluation of the ethical aspects of a clinical trial of medicinal products and the aspects set out in Article 7 of Regulation No 536/2014 for the ethics committee of clinical studies of medicinal products shall be covered by the State Agency of Medicines in accordance with the laws and regulations regarding clinical studies of medicinal products and the laws and regulations regarding the price list of paid services. The Cabinet shall determine the procedures by which the State Agency of Medicines shall pay to the ethics committee of clinical studies of medicinal products for the evaluation of a clinical trial of medicinal products, and also the percentage distribution of the fee for the work for the review of an application for a clinical trial of medicinal products.

[15 December 2005; 28 October 2010; 20 April 2023]

Section 30. The State Agency of Medicines and the Food and Veterinary Service shall, according to their competence, issue authorisations for clinical trials of medicinal products or, in the case of veterinary medicinal products - for clinical investigations of medicinal products, and shall supervise clinical trials of medicinal products or clinical investigations of veterinary medicinal products.

[20 April 2023]

Section 31. The registration of medicinal products shall be suspended or revoked if:

1) the medicinal products in being used in conformity with the information indicated in the registration documents (instructions for use (package leaflet) and other technical standard documentation) are harmful;

2) the medicinal products have no therapeutic effect;

3) the qualitative and quantitative composition of the medicinal products does not conform to the registration documentation;

4) false information has been submitted or the information in the registration documentation is not complete, or controls have not been conducted for the medicinal products and the components thereof in conformity with the information included in the registration documentation;

5) the labelling or the instructions for use (package leaflet) of the medicinal products do not conform to the laws and regulations on the labelling of medicinal products;

6) there is a court judgment regarding the violation of intellectual property rights;

7) the medicinal product registration documentation does not conform to the requirements of European Community legislation;

8) the applicant for registration has submitted an application for the revocation or suspension of the medicinal product registration;

9) the payments associated with the registration of medicinal products determined in Section 29 of this Law have not been performed;

10) the requirements laid down in the laws and regulations regarding pharmacovigilance are not conformed to.

[16 April 2003; 29 November 2012]

Section 32.

[15 December 2005]

Chapter IV.¹
Hospital Exemptions

[20 June 2024]

Section 32.¹ (1) The hospital exemptions may be used in medical treatment if a medical treatment institution has obtained a permit from the State Agency of Medicines for the use of such medicinal products in medical treatment. The State Agency of Medicines, based on the evaluation of ethical aspects conducted by the ethics committee for these medicinal products and clinical trials thereof, shall issue the permit for the use of the hospital exemptions in medical treatment in accordance with the laws and regulations regarding the hospital exemptions if the manufacturer of such medicinal products has obtained the special permit (licence) for the manufacturing of the hospital exemptions specified in Section 51.³, Paragraph one of this Law.

(2) The hospital exemptions shall be manufactured in the Republic of Latvia in accordance with the principles of good manufacturing practice.

(3) The Cabinet shall issue the regulations regarding the requirements for the use of the hospital exemptions in medical treatment and for the issuance of the permit to a medical treatment institution for the use of such medicinal products.

(4) A medical treatment institution that has the right to use the hospital exemptions in medical treatment shall, in accordance with the laws and regulations regarding the hospital exemptions, ensure the traceability of use of medicinal products, pharmacovigilance, and monitoring of patients after use thereof. The medical treatment institution shall not use the hospital exemptions in medical treatment of a patient, unless written consent has been obtained from the patient.

[20 June 2024]

Section 32.² (1) In accordance with the laws and regulations regarding the hospital exemptions, a patient has the right to receive a compensation for harm caused to his or her health or life resulting from the use of the hospital exemptions in medical treatment.

(2) A medical treatment institution that uses in medical treatment the medicinal products referred to in Section 32.¹, Paragraph one of this Law has the obligation to insure its own civil liability and also that of the attending physician and medical practitioners for harm caused to the health or life of a patient involved in the use of the hospital exemptions. The Cabinet shall determine the procedures for civil liability insurance, the minimum liability limit of the insurance contract, and the mandatory risks to be insured by the medical treatment institution that has the right to use the hospital exemptions.

[20 June 2024]

Chapter V
Pharmacies

Section 33. A pharmacy is engaged in the preparation of medicinal products pursuant to prescriptions and written requests from medical treatment institutions, in the storage and distribution of medical treatment products, goods to be used for health care or body care and in the provision of pharmaceutical care, as well as in distribution of the food products determined by the Cabinet.

[29 November 2012]

Section 33.¹ A veterinary pharmacy is engaged in the purchasing, storage and distribution of veterinary medicinal products, instruments and goods that are used in veterinary medicine, goods intended for animal care, as well as preparation of veterinary medicinal products pursuant to the veterinary prescriptions and provision of consultations regarding the use of veterinary medicinal products, instruments and products intended for animal care.

[23 October 2008]

Section 34. Depending on the type of and restrictions on their activities, pharmacies shall be classified as follows:

1) general or open-type pharmacies;

2) closed-type pharmacies or pharmacies of medical treatment institutions;

3) veterinary pharmacies;

4) [28 October 2010].

[15 December 2005; 28 October 2010]

Section 35. (1) General or open type pharmacies are permitted to:

1) package medicinal products in accordance with the requirements of technical standards;

2) prepare medicinal products pursuant to a prescription, including a veterinary prescription, and upon written request of a medical treatment institution or a veterinary medical practice institution;

3) issue medicinal products upon receipt of a prescription, including a veterinary prescription, or to a veterinary medical practice institution, upon receipt of written request of a practising veterinarian;

4) distribute the means of medical treatment to medical treatment institutions and social care institutions, and also to the warehouse of means of medical treatment of the National Armed Forces;

5) distribute the means of medical treatment to natural persons;

6) distribute the means of medical treatment to a ship, including a ship outside the territory of the Republic of Latvia, and to a ship's agent for the supply of the ship. They may distribute medicinal products to the ship's agent if the ship's agent has the permit for the distribution of medicinal products specified in Section 25.⁴, Paragraph two of this Law;

7) distribute medicinal products to other pharmacies in accordance with the laws and regulations regarding the distribution of medicinal products.

(2) The activities set out in Paragraph one, Clauses 1 and 2 of this Section shall not be permitted in branches of pharmacies in which there is no pharmacist.

(3) Closed type pharmacies or pharmacies of medical treatment institutions are permitted to:

1) package medicinal products in accordance with the requirements of technical standards;

2) prepare medicinal products according to the requests of medical treatment institutions;

3) distribute the means of medical treatment to medical treatment institutions.

(4) When discharging a patient from an inpatient medical treatment institution or a day hospital and also, in exceptional cases, to outpatient patients of an inpatient medical treatment institution, a medical treatment institution may dispense medicinal products if it is necessary for the continuation of medical treatment or there are other objective reasons that hinder receipt of the medicinal products. The Cabinet shall issue the regulations regarding the dispensing of and payment for medicinal products to patients upon discharge from an inpatient medical treatment institution and a day hospital and also to outpatient patients of an inpatient medical treatment institution.

(5) In veterinary pharmacies:

1) prescription and non-prescription veterinary medicinal products shall be distributed;

2) goods intended for animal care and instruments and goods that are used in veterinary medicine shall be distributed;

3) prescription veterinary medicinal products shall be delivered against a prescription or a written request by a practising veterinarian;

4) only a pharmacist is entitled to prepare veterinary medicinal products;

5) veterinary medicinal products shall be pre-packed in accordance with the requirements of technical standards.

(6) [28 October 2010]

[19 March 1998; 1 June 2000; 14 June 2021; 16 April 2003; 15 December 2005; 23 October 2010; 9 December 2021; 20 June 2024]

Section 36. (1) A pharmacy shall be established in the form of a pharmacist's practice, a joint practice (a Civil Law company) or a capital company. In respect of the performance of pharmaceutical care in a pharmacy owned by a local government or other person other than a pharmacist, an employment contract shall be entered into with a certified pharmacist. An in-patient medical treatment institution or day hospital; may open a closed type of pharmacy.

(2) A pharmacy may operate in the form of a capital company, if at least one of the following conditions is observed:

1) not less than 50 per cent of capital shares (shares) of a capital company are owned by a pharmacist;

2) at least half of the members of the board of a capital company (executive institution) is certified pharmacists.

(3) A pharmacy may be established by a pharmacist's assistant who has been registered as an individual merchant or has established a capital company in compliance with the condition that the number of inhabitants does not exceed 4000 in a municipality, municipality town or municipality rural territory where the pharmacy is established and there are no other pharmacies or pharmacy branches within a radius of five kilometres. The provisions of Paragraph one of this Section regarding entering into an employment contract with a certified pharmacist shall not apply to such case. A pharmacy in the form of a capital company established by a pharmacist's assistant may operate, if not less than 50 per cent of capital shares (shares) of a capital company are owned by a pharmacist's assistant. A special permit (licence) shall be issued for the operation of a pharmacy for five years. A special permit (licence) may be issued repeatedly. During the term of validity of a special permit (licence) a pharmacy owned by a pharmacist's assistant shall not be taken into account as criterion for location, when granting a special permit (licence) for opening (operating) of the pharmacy conducted by a pharmacist.

(4) A pharmacy may open branches. The branch of a general type pharmacy may be established in a municipality, municipality town or municipality rural territory where the number of inhabitants does not exceed 4000 and where there are no other pharmacies or pharmacy branches within a radius of five kilometres. The name of the branch shall indicate the name of the pharmacy, which has established the branch.

[14 June 2001; 16 April 2003; 9 August 2010 / The new wording of the Section shall come into force on 1 January 2011. See Paragraph 24 of Transitional Provisions]

Section 37. In order for a pharmacy to commence operations, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law and the laws and regulations regarding the operation of pharmacies and the distribution of veterinary medicinal products, and, in accordance with the procedures laid down in the laws and regulations regarding the licensing of pharmaceutical or veterinary pharmaceutical activities, to obtain the special permit (licence) for opening (operating) the pharmacy specifying the permitted field of activity.

[20 June 2024]

Section 38. (1) A pharmacy shall be managed by a responsible manager of the pharmacy who shall be responsible for its work and who has obtained a pharmacist professional qualification certificate.

(1¹) A pharmacist's assistant who has continuous experience of pharmacist's assistant in a pharmacy of at least five years may manage a pharmacy and be responsible for its work in a municipality, municipality town or municipality rural territory where the number of inhabitants does not exceed 4000 and where there are no other pharmacies or pharmacy branches managed by a pharmacist within a radius of five kilometres. If a pharmacy or pharmacy branch managed by a pharmacist is established in the relevant municipality, municipality town or municipality rural territory where the number of inhabitants does not exceed 4000, a pharmacist's assistant shall retain the right to manage a pharmacy and the duty to be responsible for its work until the end of the term of validity of the special permit (licence).

(2) A pharmacist and pharmacist's assistant who work in a pharmacy shall be:

1) registered with the Latvian Pharmacist Society in accordance with the procedures stipulated by the Cabinet and shall observe the ethics code approved by the Latvian Pharmacist Society;

2) raise professional qualifications by taking part in the continuous education process recognised by the Latvian Pharmacist Society.

(3) A pharmacist and pharmacist's assistant who has acquired his or her education in a state which is not a Member State of the European Union or a state of the European Economic Area, as well as in other states as is provided for in international agreements ratified by the Saeima, and whose diploma has been recognised in accordance with the procedures laid down in law, in order to commence independent practise in a pharmacy must work for at least one year in a pharmacy under the surveillance of a pharmacist.

[16 April 2003; 15 December 2005; 9 August 2010; 28 October 2010 / Paragraph 1.¹ shall come into force on 1 January 2011. See Paragraph 24 of Transitional Provisions]

Section 38.¹ That laid down in Sections 33, 36 and 38 of this Law shall not apply to veterinary pharmacies.

[28 October 2010]

Section 39.

[1 January 2011 / See Transitional Provisions]

Section 40. (1) The manager and deputy manager of one pharmacy may not concurrently be the manager or deputy manager of another pharmacy, or the responsible pharmacist or the deputy responsible pharmacist or department manager of a medicinal product wholesaler, or a head of production or a head of control service of a medicinal product manufacturing undertaking.

(2) A pharmacy is permitted to distribute veterinary medicinal products if:

1) a veterinarian or veterinary paramedic who is engaged in such activities has received a certificate of veterinary medical practice or a certificate for the distribution of veterinary medicinal products issued by the Latvian Association of Veterinarians;

2) a pharmacist, pharmacist's assistant or veterinarian's assistant who is engaged in such activities has received a certificate for the distribution of veterinary medicinal products issued by the Latvian Association of Veterinarians.

(3) If a general or open type pharmacy distributes veterinary medicinal products, then an official who has a higher education in pharmacy or veterinary medicine and who is responsible for the trade of veterinary medicinal products shall be specified therein, and the distribution of veterinary medicinal products shall be specified as a special field of activity in a special permit (licence) to open (operate) a pharmacy. The State Agency of Medicines shall inform the Food and Veterinary Service regarding the issued special permit (licence) and it shall register such a pharmacy in the register of objects under supervision of the Service.

(4) An official who has a higher education in pharmacy or veterinary medicine and who is responsible for the trade of veterinary medicinal products shall be determined in a veterinary pharmacy and a special permit (licence) to open (operate) a pharmacy shall be received.

(5) An official responsible for the trade of veterinary medicinal products may not concurrently be the responsible official in another pharmacy.

[28 October 2010; 29 November 2012]

Section 40.¹ (1) The Latvian Association of Veterinarians shall perform the following State administration tasks:

1) issue, re-register and revoke certificates for the distribution of veterinary medicinal products;

2) register recipients of a certificate for the distribution of veterinary medicinal products and maintain the register of certified persons;

3) draw up and approve a programme for examination of qualifications for a person who is applying for a certificate for distribution of veterinary medicinal products, and evaluate the qualifications of the applicant.

(2) The Cabinet shall determine the fee for issue and re-registration of a certificate for the distribution of veterinary medicinal products.

(3) In performing the tasks referred to in Paragraph one of this Section the Latvian Association of Veterinarians:

1) is entitled to issue administrative acts;

2) shall be under functional subordination of the Ministry of Agriculture.

(4) The contestation or appeal of the decision taken by the Latvian Association of Veterinarians during the fulfilment of the tasks referred to in Paragraph one of this Section shall not suspend the operation thereof.

[28 October 2010; 29 November 2012]

Section 41. (1) A pharmacy shall be responsible for the quality of the medicinal products it distributes and the carrying out of pharmaceutical care. It may only purchase medicinal products from medicinal product manufacturers, medicinal product importers, medicinal product wholesalers, and pharmacies, completing appropriate accompanying documents. Medicinal plants may be purchased also from natural persons, but such may be distributed only if an appropriate permit from the State Agency of Medicines has been received, or, if the plants are intended for animals, a permit from the Food and Veterinary Service.

(2) A pharmacy may purchase individually assigned medicinal products (registered in the European Union in accordance with Regulation No 726/2004) in accordance with the procedures laid down in the laws and regulations regarding the distribution of medicinal products in another European Union Member State or a country of the European Economic Area from the manufacturers and distributors of medicinal products whose activities have been permitted by the competent authorities of the respective country if the medicinal products are required for the treatment of a specific patient, including for the treatment of rare diseases, and the specific medicinal products are not available in the Republic of Latvia - based on a prescription issued in accordance with the laws and regulations, or upon requirement of a medical treatment institution. The Cabinet shall determine the cases in which a pharmacy may purchase medicinal products in another European Union Member State or a country of the European Economic Area from manufacturers and distributors and the requirements for the distribution of such medicinal products.

[20 June 2024]

Section 42. In general and closed-type pharmacies, medicinal products may be prepared, controlled and distributed only by specialists who have a pharmaceutical education. At a branch of a pharmacy which is located in a municipality, municipality town or municipality rural territory where the number of inhabitants does not exceed 4000 and where there are no other pharmacies or branches of pharmacies within a radius of five kilometres, the medicinal products may be distributed also by medical practitioners. The operations of the branch of the pharmacy aforementioned shall be discontinued within one month, if another pharmacy or branch of a pharmacy, in which a specialist with a pharmaceutical education is employed, is opened in this area. The Cabinet shall determine the requirements for a medical practitioner and the range of medical practitioners who may distribute medicinal products at a pharmacy branch.

[16 April 2003; 9 August 2010; 20 June 2024]

Chapter VI
Medicinal Product Wholesalers

Section 43. A medicinal product wholesaler is engaged in the purchase, storage and distribution of medicinal products or other means of medical treatment, as well as goods to be used for health care or body care, medical goods intended for the disabled, pharmacy equipment, and medical instruments or apparatus.

[23 October 2008]

Section 44. Veterinary medicinal product wholesalers are permitted to purchase, store and distribute only medicinal products, means of medical treatment and goods intended for care of animals. Medicinal products shall be labelled with a notice "Lietošanai dzīvniekiem" [For use in animals].

Section 45. (1) In order for a medicinal product wholesaler to commence operations, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law and the laws and regulations regarding the distribution of medicinal products, and, in accordance with the laws and regulations regarding the licensing of pharmaceutical activities, to obtain the special permit (licence) for the wholesale distribution of medicinal products specifying the permitted field of activity.

(2) In order for a veterinary medicinal product wholesaler to commence operations, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law and the laws and regulations regarding the distribution of veterinary medicinal products, and, in accordance with Section 1 of Chapter VII of Regulation No 2019/6 and the laws and regulations regarding the licensing of veterinary pharmaceutical activities, to obtain the special permit (licence) for opening (operating) a veterinary medicinal product wholesaler.

(3) The special permit (licence) referred to in Paragraphs one and two of this Section shall not release from the obligation to obtain the special permit (licence) for the manufacturing or importing of medicinal products or veterinary medicinal products referred to in Section 51, Paragraphs one and two of this Law, if any manufacturing or importing activities are performed, and to meet the conditions laid down in relation thereto.

[20 June 2024 / The new wording of the Section shall come into force on 1 August 2020. See Paragraph 33 of Transitional Provisions]

Section 45.¹ A medicinal product wholesaler that has obtained the special permit (licence) for the wholesale distribution of medicinal products may distribute veterinary medicinal products if it has obtained the special permit (licence) for the opening (operating) of a veterinary medicinal product wholesaler in accordance with Section 45, Paragraph two of this Law.

[20 June 2024 / See Paragraph 34 of Transitional Provisions]

Section 46.

[22 April 2004]

Section 46.¹ (1) In a medicinal product wholesaler, in respect of the compliance with of good distribution practices, or in a veterinary medicinal product wholesaler, in respect of the distribution of veterinary medicinal products, a responsible official shall be approved:

1) whose education and professional experience complies with the requirements laid down in the laws and regulations regarding the distribution of medicinal products or veterinary medicinal products;

2) who does not suffer from mental illness, addiction to alcohol, narcotic, psychotropic or toxic substances;

3) who has an unimpeachable reputation, which shall be recognised if:

a) this person has been convicted of committing a criminal offence;

b) [23 October 2008];

c) this person has not been administratively penalised repeatedly within one year for violations of pharmaceutical or veterinary pharmaceutical activities;

4) [23 October 2008].

[16 April 2003; 15 December 2005; 23 October 2008]

Section 47. A medicinal product wholesaler shall be liable for the quality of the medicinal products it distributes. It may purchase medicinal products only from medicinal product manufacturers, medicinal product importers and medicinal product wholesalers, at the same time receiving documents, which certify the quality of the medicinal products.

[1 June 2000; 23 October 2008; 29 November 2012]

Section 48. (1) A medicinal product wholesaler may distribute medicinal products to licensed pharmacies, licensed medicinal product wholesalers and manufacturers, and also medical treatment institutions, including practitioners at a practice, social care institutions, the warehouse of means of medical treatment of the National Armed Forces, veterinary medical practice institutions for ensuring the operations thereof, and ships, including ships outside the territory of the Republic of Latvia, and ship's agents for the supply of the ship. Medicinal products may only be distributed to other persons if such persons have a permit issued by the State Agency of Medicines for the purchase of medicinal products or, in respect of veterinary medicinal products, a permit issued by the Food and Veterinary Service for the purchase of veterinary medicinal products, and if the relevant persons and institutions use the medicinal products only for the provision of the operation thereof, but they have no right to distribute these medicinal products.

(1¹) A medicinal product wholesaler is permitted, in accordance with the procedures laid down in laws and regulations, to supply veterinary medicinal products to the Food and Veterinary Service for the performance of the functions laid down in the Veterinary Medicine Law.

(1²) A medicinal product wholesaler may distribute medicinal products to the ship's agent if the ship's agent has the permit for the distribution of medicinal products specified in Section 25.⁴, Paragraph two of this Law.

(1³) The Cabinet shall issue the regulations regarding the issuance of the permit for the purchase of medicinal products to the persons and institutions specified in the second sentence of Paragraph one of this Section.

(2) Medicinal products manufactured in foreign states may be brought in and distributed in the Republic of Latvia, if they have been acquired from manufacturers or distributors, which have been permitted to operate by the respective competent state authorities.

[23 October 2008; 28 October 2010; 29 November 2012; 9 December 2021; 20 June 2024]

Section 49. Means of medical treatments which are permitted to be distributed outside of pharmacies may also be distributed by medicinal product wholesalers to other legal persons.

[19 March 1998]

Chapter VII
Manufacturing and Importing of Medicinal Products and Active Substances and Distribution of Active Substances

[29 November 2012]

Section 50. A medicinal product manufacturer manufactures and distributes medicinal products and active substances.

[23 October 2008]

Section 50.¹ A medicinal product importer imports and distributes medicinal products and active substances.

[29 November 2012]

Section 51. (1) In order to manufacture fully or partially or to import medicinal products, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law and the laws and regulations regarding the manufacture and control of medicinal products, and, in accordance with the laws and regulations regarding the licensing of pharmaceutical activities, to obtain the relevant special permit (licence) for the manufacturing or importing of medicinal products specifying the manufacturing or importing activities as the permitted field of activity. The respective special permit for the manufacturing of medicinal products shall be required even if the medicinal products are intended for export.

(2) In order to manufacture fully or partially or to import veterinary medicinal products, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law, Chapter VI of Regulation No 2019/6, and the laws and regulations regarding the manufacture and control of veterinary medicinal products, and, in accordance with the laws and regulations regarding the licensing of pharmaceutical activities and Chapter VI of Regulation No 2019/6, to obtain the relevant special permit (licence) for the manufacturing or importing of veterinary medicinal products specifying the manufacturing or importing activities as the permitted field of activity. The respective special permit for the manufacturing of veterinary medicinal products shall also be required in the case referred to in Article 88(1(a) of Regulation No 2019/6.

(3) In order to manufacture or import investigational medicinal products and auxiliary medicinal products, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law, Regulation No 2017/1569, and the laws and regulations regarding the manufacture and control of medicinal products, and, in accordance with Article 61 of Regulation No 536/2014, and the laws and regulations regarding the licensing of pharmaceutical activities, to obtain the relevant special permit (licence) for the manufacturing or importing of investigational medicinal products specifying the manufacturing or importing activities as the permitted field of activity.

(4) In order to manufacture, import, or distribute active substances for medicinal products intended for humans, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law, Regulation No 1252/2014, and the laws and regulations regarding the manufacturing of medicinal products and importing and distribution of active substances, and, in accordance with the laws and regulations regarding the importing and distribution of active substances, to register the type of activity thereof.

(5) The manufacturer of active substances may obtain the special permit (licence) for the manufacturing of active substances for medicinal products intended for humans in accordance with the laws and regulations regarding the licensing of pharmaceutical activities if such a special permit (licence) is required in relation to the bringing in, distribution, or registration of active substances in a third country and if appropriate premises and equipment, including devices, and also personnel and documentation are ensured in accordance with this Law, Regulation No 1252/2014, and the laws and regulations regarding the manufacturing of medicinal products.

(6) In order to manufacture, import, or distribute active substances used as starting materials in veterinary medicinal products, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law and Chapter VI of Regulation No 2019/6, and, in accordance with Article 95 of Regulation No 2019/6, to register the type of activity thereof.

(7) The special permit (licence) for the manufacturing of medicinal products referred to in Paragraphs one and two of this Section shall also be required for various processes of division, packaging (repackaging), and presentation, but for veterinary medicinal products, in accordance with Article 88(1)(b) of Regulation No 2019/6.

(8) The relevant special permit (licence) for the manufacturing or importing referred to in Paragraphs one, two, and three of this Section shall include the permit for the wholesale distribution of medicinal products to which this special permit (licence) refers.

(9) The Cabinet shall determine cases when the special permit (licence) for the manufacturing and importing of medicinal products, including investigational medicinal products and auxiliary medicinal products, and veterinary medicinal products is not required.

[20 June 2024 / The new wording of the Section shall come into force on 1 August 2020. See Paragraph 33 of Transitional Provisions]

Section 51.¹ The principles and guidelines published in the European Commission Guidelines to good manufacturing practice for medicinal products shall be conformed to in the manufacturing of medicinal products and active substances and in the control of the manufacturing thereof, and also in the importing of medicinal products.

[29 November 2012; 20 June 2024]

Section 51.² The manufacturer or importer of medicinal products intended for humans may manufacture or import veterinary medicinal products if the special permit (licence) for the manufacturing or importing of veterinary medicinal products has been obtained in accordance with the requirements laid down in Section 51, Paragraph two of this Law.

[20 June 2024 / See Paragraph 34 of Transitional Provisions]

Section 51.³ (1) In order to manufacture the hospital exemptions, it shall be required to ensure appropriate premises and equipment, including devices, and also personnel and documentation in accordance with this Law and the laws and regulations regarding the manufacture and control of medicinal products, and, in accordance with the laws and regulations regarding the licensing of pharmaceutical activities, to obtain the special permit (licence) for the manufacturing of the hospital exemptions.

(2) The Cabinet shall determine the requirements for the manufacturing and distribution of the hospital exemptions.

[20 June 2024]

Section 52. In a medicinal product manufacturing undertaking in respect of the manufacture of medicinal products a qualified person shall be designated the qualifications and professional experience requirements of whom, shall be determined by the Cabinet.

[16 April 2003]

Section 52.¹ (1) The importer of medicinal products, including auxiliary medicinal products, shall designate an official responsible for the importing of medicinal products whose qualification and professional experience conform to the criteria for qualification and professional experience of the official responsible for the manufacturing of medicinal products laid down in the laws and regulations regarding the manufacture and control of medicinal products.

(2) The manufacturer and importer of investigational medicinal products shall designate a qualified person responsible for the manufacturing and importing of medicinal products whose qualification and professional experience conform to the criteria for qualification and professional experience of the official responsible for the manufacturing of medicinal products laid down in the laws and regulations regarding the manufacture and control of medicinal products in accordance with Article 61(2)(b) of Regulation No 536/2014.

(3) The manufacturer and importer of veterinary medicinal products shall designate a person responsible for the manufacturing or importing of veterinary medicinal products whose qualification and professional experience conform to the criteria for qualification and professional experience of the qualified person responsible for the manufacturing and batch release of veterinary medicinal products, as specified in Article 97(2) and (3) of Regulation No 2019/6.

(4) The manufacturer of the hospital exemptions shall designate a person responsible for the manufacturing of medicinal products and the Cabinet shall determine the requirements for qualification and professional experience of such person.

[20 June 2024]

Section 53. A medicinal product manufacturer shall ensure, in conformity with the approved documentation of technical standards, the quality control of medicinal products during the manufacturing and storage process, and shall be liable for the quality of the medicinal products manufactured irrespective of whether the full manufacturing process was performed on site or whether other natural or legal persons were also involved in it.

[19 March 1998; 23 October 2008]

Section 54. (1) The manufacturer or importer of medicinal products may distribute the manufactured medicinal products to manufacturers or importers of medicinal products, licensed medical product wholesalers, licensed pharmacies, medical treatment institutions, and veterinary medical practice institutions for ensuring the operations thereof, and ships, including ships outside the territory of the Republic of Latvia, and ship's agents for the supply of the ship.

(2) The manufacturer or importer of medicinal products may distribute medicinal products to the ship's agent if the ship's agent has the permit for the distribution of medicinal products specified in Section 25.⁴, Paragraph two of this Law.

(3) The manufacturer of the hospital exemptions may supply the manufactured medicinal products to another medical treatment institution in the Republic of Latvia if the specific medical treatment institution has the special permit issued by the State Agency of Medicines for the use of such medicinal products, as specified in Section 32.¹ of this Law.

[20 June 2024]

Section 55. A medicinal product manufacturer may also distribute means of medical treatment, which are permitted to be distributed outside of pharmacies, to other legal persons.

[19 March 1998; 23 October 2008]

Section 56. A medicinal product manufacturer or importer has the right to give, in accordance with the procedures stipulated by the Cabinet, free samples of medicinal products to doctors and practising veterinarians, as well as to medical and veterinary medical educational and scientific institutions, informing the State Agency of Medicines in writing regarding such, but with respect to veterinary medicinal products the Food and Veterinary Service.

[1 June 2000; 16 April 2003; 15 December 2005; 23 October 2008; 29 November 2012]

Chapter VIII
Licensing and Certification

Section 57. The Cabinet shall determine procedures according to which special permits (licences) and certificates shall be issued and revoked.

Section 58. (1) A person has the right to receive a pharmacist professional qualification certificate:

1) who has acquired a higher pharmaceutical education in the Republic of Latvia or in a foreign state and whose acquired education and length of professional experience is recognised in accordance with the procedures laid down in laws and regulations. For the recognition of professional experience it is necessary that:

a) the pharmacist has uninterruptedly worked for three years in a pharmacy in the Republic of Latvia, a Member State of the European Union or a state in the European Economic Area. Professional experience gained in a foreign state shall be certified by a certificate or other document, which has been issued by the competent professional organisation of the relevant state;

b) the practice of the pharmacist in a pharmacy shall not be interrupted for longer than five years since the day when the submission to the certification authority was submitted for the acquisition of a pharmacist professional qualification certificate;

2) who does not suffer from mental illness, addiction to alcohol, narcotic, psychotropic or toxic substances;

3) who has an unimpeachable reputation, which shall be recognised if:

a) this person has been convicted of committing a criminal offence;

b) a court has not recognised this person as an insolvent debtor;

c) this person has not been administratively penalised repeatedly within one year for violations of pharmaceutical activities.

(2) The Latvian Pharmacist Society shall establish and maintain a pharmacist and pharmacist's assistant register and shall certify the length of his or her professional experience.

[16 April 2003; 15 December 2005]

Section 59.

[28 October 2010]

Section 60.

[22 April 2004]

Section 60.¹ The special permit (licence) specified in Section 45, Paragraphs one and two of this Law may be obtained by a person who conforms to the requirements for the distribution of medicinal products or veterinary medicinal products laid down in the laws and regulations governing the field of pharmacy or veterinary pharmacy.

[23 October 2008; 20 June 2024]

Section 61. (1) Legal persons that have ensured the conditions, control capabilities, and personnel necessary for the manufacturing or importing of medicinal products in accordance with Section 51, Paragraph one, Section 52, and Section 52.¹, Paragraph one of this Law have the right to obtain the special permit (licence) for the manufacturing or importing of medicinal products.

(2) Legal persons that have ensured the conditions, control capabilities, and personnel necessary for the manufacturing or importing of investigational medicinal products and auxiliary medicinal products in accordance with Section 51, Paragraph three and Section 52.¹, Paragraph two of this Law have the right to obtain the special permit (licence) for the manufacturing or importing of such medicinal products.

(3) Legal persons that have ensured the conditions, control capabilities, and personnel necessary for the manufacturing of the hospital exemptions in accordance with Section 51.³, Paragraph one and Section 52.¹, Paragraph four of this Law have the right to obtain the special permit (licence) for the manufacturing of such medicinal products.

(4) Legal persons that have ensured the conditions, control capabilities, and involvement of relevant specialists for the manufacturing or importing of veterinary medicinal products in accordance with Section 51, Paragraph two and Section 52.¹, Paragraph three of this Law have the right to obtain the special permit (licence) for the manufacturing or importing of veterinary medicinal products. The licence shall indicate the veterinary medicinal products or pharmaceutical forms, which are permitted to be manufactured or imported.

(5) Legal persons that have ensured the conditions, control capabilities, and personnel necessary for the manufacturing of active substances and have also registered their type of activities in accordance with Section 51, Paragraph four of this Law have the right to obtain the special permit (licence) for the manufacturing of such substances.

[20 June 2024]

Section 61.¹ (1) If the results of verification of the manufacturer and importer of medicinal products, including auxiliary medicinal products, and the manufacturer of active substances, and also the manufacturer of the hospital exemptions confirm compliance with good manufacturing practice, the State Agency of Medicines shall issue the certificate of good manufacturing practice not later than within 90 days after the verification of good manufacturing practice in accordance with the laws and regulations regarding the manufacture and control of medicinal products, but for investigational medicinal products, the certificate of good manufacturing practice shall be issued by the State Agency of Medicines in accordance with Article 17(6) of Regulation No 2017/1569.

(2) If the results of verification of the medicinal product manufacturer, the importer of medicinal products, and the medicinal product wholesaler, and also the distributor of active substances for medicinal products intended for humans confirm compliance with good distribution practice, the State Agency of Medicines shall issue a certificate of good distribution practice not later than within 90 days after the verification of good distribution practice in accordance with this Law and the laws and regulations regarding the distribution of medicinal products and active substances.

(3) If the results of the evaluation of the manufacturer and importer of veterinary medicinal products and active substances used as starting materials in veterinary medicinal products confirm compliance with good manufacturing practice, the Food and Veterinary Service shall issue a certificate of good manufacturing practice within the time limit set out in Article 94(1) of Regulation No 2019/6.

(4) If the results of the evaluation of the manufacturer, importer, and distributor of veterinary medicinal products and active substances used as starting materials in veterinary medicinal products confirm compliance with good distribution practice, the Food and Veterinary Service shall issue a certificate of good distribution practice within 90 days after receipt of the submission.

[29 November 2012; 5 October 2023; 20 June 2024]

Section 62. A pharmacy, a medicinal product wholesaler, a medicinal product manufacturer, a medicinal product importer, a medical treatment institution, a social care institution, and a veterinary medical practice institution shall provide the Ministry of Health, the State Agency of Medicines, the Food and Veterinary Service, the Health Inspectorate, and the Latvian Pharmacist Society with information on their pharmaceutical activities and medicinal products as is necessary for the performance of the functions laid down in this Law and other laws and regulations regarding the distribution and control of medicinal products.

[16 April 2003; 15 December 2005; 27 September 2007; 23 October 2008; 28 October 2010; 29 November 2012; 9 December 2021]

Chapter IX
Adoption, Contesting, and Appeal of Decisions

[21 May 2020 / The new wording of the title of this Chapter shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 63. [21 May 2020 / See Paragraph 28 of Transitional Provisions]

Section 64. (1) The State Agency of Medicines, the National Health Service, the Health Inspectorate of Latvia and the Food and Veterinary Service in the performance of the functions laid down in laws and regulations shall take decisions in accordance with the procedures and time periods laid down in law insofar as this Law does not lay down otherwise.

(2) The National Health Service shall:

1) not later than within 90 days, examine and take a decision in respect of a submission regarding a reduction in the base price to be compensated for medicinal products and medical devices;

2) not later than within 60 days, examine and take a decision in respect of a submission regarding the inclusion of medicinal products and medical devices in the list of medicinal products intended to be compensated in out-patient medical treatment.

(2¹) The State Agency of Medicines shall examine the submission regarding the authorisation of a clinical trial of medicinal products and take a decision within the time limits specified in Articles 5, 6, 7, 8, 14, 17, 18, 19, 20, 21, 22, and 23 of Regulation No 536/2014.

(2²) The State Agency of Medicines shall review the registration form and the documents appended thereto and take a decision to perform an examination or to register the manufacturer, importer or distributor of active substances not later than within 60 days.

(2³) The Food and Veterinary Service shall examine the submission regarding the authorisation of a clinical investigation of medicinal products and take the decision within the time limit specified in Article 9(3) of Regulation No 2019/6.

(2⁴) The Food and Veterinary Service shall examine the registration form and the documents attached thereto and take the decision on the verification of compliance and on the registration of the manufacturer, importer, or distributor of active substances used as starting materials in veterinary medicinal products within the time limit specified in Article 95(4) of Regulation No 2019/6.

(3) Decisions taken by the State Agency of Medicines, the National Health Service and the Health Inspectorate of Latvia may be disputed to the Ministry of Health, but decisions taken by the Food and Veterinary Service - to the Ministry of Agriculture.

(4) Decisions of the Ministry of Health and the Ministry of Agriculture, which are taken regarding the decisions of the institutions referred to in this Section, may be appealed to a court in accordance with the procedures laid down in the Administrative Procedure Law.

(5) The dispute of the decisions referred to in Paragraph one of this Section and the appeal of decisions referred to in Paragraph four of this Section shall not hold the implementation of the relevant decision.

[15 December 2005; 27 September 2007; 24 April 2008; 1 December 2009; 29 November 2012; 11 April 2019; 20 April 2023; 5 October 2023]

Section 64.¹ (1) The State Agency of Medicines and the Food and Veterinary Service shall, not later than within 90 days after receipt of a submission, take a decision to issue a special permit (licence) to manufacture or import medicinal products or veterinary medicinal products or to refuse to issue a licence.

(2) The State Agency of Medicines and the Food and Veterinary Service shall, not later than within 30 days (in an exceptional case - not later than within 90 days) from the day of receipt of a submission, take a decision to re-register a special permit (licence) to manufacture or import medicinal products or veterinary medicinal products, if it is necessary to make changes in information:

1) regarding manufactured or imported medicinal products, pharmaceutical forms, the place where they are manufactured or controlled, and also regarding the qualified person;

2) on the premises which are intended for manufacturing or importing activities of medicinal products, on technical equipment and control possibilities in the manufacturing, quality control and storage process of medicinal products;

3) in relation to investigational medicinal products - on the types and forms of investigational medicinal products to be manufactured or imported, manufacturing and importing activities and manufacturing process (as in cases with deactivation of viruses or non-traditional agents), and also on the location where investigational medicinal products are manufactured, on the premises which are intended for manufacturing or importing activities of investigational medicinal products, on technical equipment and control possibilities in the manufacturing, quality control and storage process of investigational medicinal products and on the qualified person.

(3) The State Agency of Medicines shall, not later than 90 days from the day of receipt of the submission, take the decision to issue the special permit (licence) for the wholesale distribution of medicinal products or to refuse to issue the licence.

(4) The Food and Veterinary Service shall evaluate the compliance of the applicant with the requirements of the laws and regulations governing the circulation of veterinary medicinal products and shall take the decision on issuing a special permit (licence) to open (operate) a veterinary medicinal product wholesaler or on the refusal to issue a licence within the time limit set out in Article 100(4) of Regulation No 2019/6.

(5) The State Agency of Medicines shall, not later than 180 days from the day of receipt of the submission, take the decision to issue the special permit (licence) for the use of the hospital exemptions in medical treatment or to refuse to issue the licence. The decision to issue the permit for the use of the hospital exemptions in medical treatment shall not be taken if the special permit (licence) for the manufacturing of the hospital exemptions, as specified in Section 51.³, Paragraph one of this Law, has not been obtained for the relevant hospital exemptions. The State Agency of Medicines shall take the decision to issue and re-register the special permit for the manufacturing of the hospital exemptions and also to make the changes referred to Section 64.¹, Paragraph two, Clauses 1 and 2 of this Law.

(6) The deadline referred to in Paragraphs one, two, three, four, and five of this Section and Section 61.¹ of this Law shall be suspended when the State Agency of Medicines or the Food and Veterinary Service respectively establishes that additional information or documents are required for the evaluation and requests the submitter to submit such information or documents. The counting of the suspended deadline shall resume from the moment when the submitter submits the requested information or documents to the State Agency of Medicines or the Food and Veterinary Service respectively.

[29 November 2012; 5 October 2023; 20 June 2024]

Chapter X.
Suspension of the Activity of Subjects of Pharmaceutical and Veterinary Pharmaceutical Activity

[24 April 2008]

Section 65. The decision regarding suspension of the activity of the subject of pharmaceutical and veterinary pharmaceutical activity, if the laws and regulations governing the field of pharmaceuticals and veterinary pharmacy have been violated, in conformity with their competence, shall be taken by the head of the Health Inspectorate, deputy heads thereof, managers of territorial divisions of the Health Inspectorate and deputy managers thereof or by the State chief food and veterinary inspector of the Food and Veterinary Service, senior inspectors and inspectors of the Food and Veterinary Service.

Section 66. (1) If the inspector of the Health Inspectorate of Latvia or the Food and Veterinary Service in conformity with the competence thereof has determined a violation of the laws and regulations governing the field of pharmacy and veterinary pharmacy, he or she shall express a written warning to the relevant subject of pharmaceutical and veterinary pharmaceutical activity. All of the determined violations of the laws and regulations governing the field of pharmacy and veterinary pharmacy shall be indicated in the warning and recommendations shall be provided, and the term for the elimination of violations shall be set.

(2) Taking into account the actual possibilities for elimination of a violation, the time period for elimination of violations included in the warning shall be determined not less than:

1) two years if for the rectification of the violation capital construction is necessary;

2) six months if partial reconstruction of a building or capital repairs of machinery are necessary for the rectification of the violation.

(3) In other cases that are not referred to in Paragraph two of this Section, the inspector of the Health Inspectorate of Latvia or the Food and Veterinary Service, in conformity with the competence thereof and taking into consideration the actual possibilities for the elimination of the violation, shall set the term for the elimination of the violation to be from one month up to three months.

(4) If the violations indicated in the warning have not been eliminated within the specified term, the officials referred to in Section 65 of this Law shall take a decision to suspend the activity of the relevant subject of pharmaceutical and veterinary pharmaceutical activity.

(5) The suspension of the activity of the subject of pharmaceutical and veterinary pharmaceutical activity shall be ensured by the owner or a person authorised by the owner, if there is such, with the participation of the official who took the decision to suspend the activity, or an official authorised thereof.

(6) The suspension of the activity of the subject of pharmaceutical and veterinary pharmaceutical activity shall be carried out in such a manner that:

1) the determined violations may be rectified without hindrance;

2) the deterioration of premises and machinery due to meteorological circumstances or under the influence of corrosion is reduced as much as possible;

3) the operations of other structural units and machinery is disturbed as little as possible.

(7) Control of the operation suspension shall be ensured by the official who has taken the decision regarding the suspension of the operation or the official authorised thereof.

(8) The activity of the subject of pharmaceutical and veterinary pharmaceutical activity may be suspended without a previous warning, if due to the violation of the laws and regulations governing pharmacy or veterinary pharmacy:

1) medicinal products not conforming with the quality or not allowed in Latvia are distributed;

2) the manufacture and distribution of separate medicinal products is carried out without a special permit (licence) or other permit, if such is necessary in accordance with the laws and regulations governing pharmacy or veterinary pharmacy;

3) dangerous substances, disease causing agents may reach foodstuffs of animal origin or environment and health or life of humans or animals is endangered.

(9) An official, who has the right to take the decision referred to in Paragraph eight of this Section regarding the suspension of the activity, shall take this decision not later than within three working days after the violations referred to in Paragraph eight of this Section have become known to him or her, and it shall be complied with immediately. The term for the elimination of other determined violations of the laws and regulations governing pharmacy or veterinary pharmacy shall be set in accordance with Paragraphs two and three of this Section.

Section 67. (1) The subject of the pharmaceutical and veterinary pharmaceutical activity shall notify in writing the official who took the decision to suspend the activity, regarding the elimination of the determined violations. Such official shall within five working days after receipt of the notification verify whether the relevant violations have been rectified.

(2) If all of the violations referred to in the warning or decision to suspend the activity have been eliminated, the relevant official shall provide a written permit for the renewal of the activity not later than within three working days after the performance of the check.

(3) If all the violations referred to in the written warning or decision regarding the suspension of the operation are not eliminated, the relevant official shall refuse the resumption of operation.

Section 68. (1) The submission, in which the decision to suspend the operation without advance warning is contested, shall be examined and the decision shall be taken within 10 working days after receipt of the submission.

(2) Contesting and appeal of the decisions of the Health Inspectorate of Latvia and the Food and Veterinary Service referred to in this Chapter shall not suspend the activity thereof.

Chapter X.¹
Trade of Means of Medical Treatment within the National Armed Forces

[9 December 2021 / Chapter shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Section 68.¹ For the purpose of ensuring performance of tasks of the National Armed Forces, the warehouse of means of medical treatment of the National Armed Forces shall ensure trade of the means of medical treatment within the National Armed Forces.

[9 December 2021 / Section shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Section 68.² The warehouse of means of medical treatment of the National Armed Forces shall purchase and store the means of medical treatment and transfer them for use free of charge for the needs of the National Armed Forces.

[9 December 2021 / Section shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Section 68.³ The Cabinet shall determine:

1) the requirements for premises, equipment, machinery, documentation, and staff of the warehouse of means of medical treatment of the National Armed Forces;

2) the procedures by which the warehouse of means of medical treatment of the National Armed Forces purchases, stores, transfers for use free of charge, records, and destroys means of medical treatment;

3) the procedures by which the warehouse of means of medical treatment of the National Armed Forces may transfer the means of medical treatment at its disposal for use free of charge to medical treatment institutions and social care institutions.

[9 December 2021 / Section shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Section 68.⁴ The following person shall be approved as an official responsible for the conformity with the requirements for trade of means of medical treatment in the warehouse of means of medical treatment of the National Armed Forces:

1) whose professional qualification conforms to the requirements laid down in laws and regulations for staff of the warehouse of means of medical treatment of the National Armed Forces;

2) who does not suffer from mental illness or who is not addicted to alcohol, narcotic, psychotropic, or toxic substances;

3) who is of impeccable reputation which shall be recognised as such if:

a) the person has not been convicted of committing a criminal offence;

b) the person has not been subject to administrative penalties for offences in the field of pharmaceuticals over a year.

[9 December 2021 / Section shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Section 68.⁵ The warehouse of means of medical treatment of the National Armed Forces shall be responsible for the quality of the purchased means of medical treatment. It is allowed to purchase, store, and transfer for use free of charge only the medicinal products registered in the Republic of Latvia and included in the Medicinal Product Register of Latvia. It is prohibited from purchasing and transferring medicinal products for use free of charge if their quality does not conform to the requirements laid down in the approved documentation of technical standards (pharmacopoeia, technical regulations, documentation approved in the course of registration of medicinal products etc.), or their expiry date has passed.

[9 December 2021 / Section shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Section 68.⁶ The warehouse of means of medical treatment of the National Armed Forces shall only purchase medicinal products from medicinal product wholesalers and general type pharmacies.

[9 December 2021 / Section shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Section 68.⁷ For the purpose of providing medical assistance to soldiers of the National Armed Forces, the National Armed Forces are entitled to transport means of medical treatment across the State border in accordance with a list approved by the Commander of the National Armed Forces when going for military training abroad or participating in an international operation.

[9 December 2021 / Section shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Section 68.⁸ For the purpose of the supervision of pharmacy, the officials of the Health Inspectorate have the right to supervise and control the warehouse of means of medical treatment of the National Armed Forces, assess conformity of the trade of medicinal products with the requirements of laws and regulations regulating the field of pharmaceuticals, and also give, within the scope of their competence, binding orders on pharmaceutical issues to the warehouse of means of medical treatment of the National Armed Forces. Officials of the Health Inspectorate have the following rights within the scope of their competence:

1) assess premises, equipment, staff, and documentation according to the work to be performed and its volume;

2) issue a written warning regarding the established violations of laws and regulations regulating the field of pharmaceuticals, set the time period for elimination of the violations included in the warning that is not shorter than that specified in Section 66, Paragraphs two and three of this Law, and if the violations indicated in the warning have not been eliminated within the set time period, take the decision to suspend operation of the warehouse of means of medical treatment of the National Armed Forces;

3) prohibit trade of any medicinal products if it has been established that they are of poor quality or falsified but, in case of doubts regarding the quality of such medicinal products, suspend trade of the relevant medicinal products until final clarification of their quality in accordance with the laws and regulations regulating the field of pharmaceuticals.

[9 December 2021 / Section shall come into force on 1 April 2022. See Paragraph 29 of Transitional Provisions]

Chapter XI
Administrative Offences in the Field of Medicinal Products for Human Use and Competence in Administrative Offence Proceedings

[21 May 2020 / Chapter shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 69. For the violation of the procedures for purchase, storage, use, accounting or destruction of medicinal products in medical treatment institutions and social care institutions, a warning or a fine from two to ten units of fine shall be imposed on a natural person but a fine from twenty to one hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 70. For the violation of the quality control procedures for medicinal products prepared at a pharmacy, a warning or a fine from two to fifteen units of fine shall be imposed on a natural person but a fine from twenty to one hundred and fifty units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 71. (1) For the violation of the provisions for distribution of medicinal products or active substances in pharmacies, a warning or a fine from five to fifteen units of fine shall be imposed on a natural person but a fine from fifty to one hundred and fifty units of fine on a legal person.

(2) For the violation of the provisions for distribution of medicinal products or active substances at medicinal product wholesalers, a warning or a fine from five to twenty units of fine shall be imposed on a natural person but a fine from fifty to two hundred units of fine on a legal person.

(3) For the violation of the provisions for distribution of medicinal products or active substances laid down for a manufacturer of medicinal products, a warning or a fine from ten to twenty units of fine shall be imposed on a natural person but a fine from one hundred to two hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 72. For the violation of the provisions for organisation of work or pharmaceutical care laid down in a pharmacy and a branch of a pharmacy, a warning or a fine from ten to twenty units of fine shall be imposed on a natural person but a fine from one hundred to two hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 73. For the violation of the procedures for transfer of free samples of medicinal products laid down for medical treatment institutions or for non-compliance with the requirements for the donation of medicinal products, a warning or a fine from ten to twenty-five units of fine shall be imposed on a natural person but a fine from one hundred to two hundred and fifty units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 74. For the violation of the provisions for distribution of unregistered medicinal products for the distribution of which a permit has been received from the State Agency of Medicines, a warning or a fine from five to twenty-five units of fine shall be imposed on a natural person but a fine from fifty to two hundred and fifty units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 75. For the violation of the provisions for distribution of medicinal products via internet, a warning or a fine from five to thirty units of fine shall be imposed on a natural person but a fine from fifty to three hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 76. For the violation of the provisions for importing and exporting of medicinal products or active substances, a warning or a fine from five to thirty-five units of fine shall be imposed on a natural person but a fine from fifty to three hundred and fifty units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 77. For the violation of the procedures for conducting clinical trials of medicinal products and non-interventional studies or labelling of investigational medicinal products and auxiliary medicinal products, a warning or a fine from five to forty units of fine shall be imposed on a natural person but a fine from fifty to four hundred units of fine on a legal person.

[20 April 2023]

Section 78. (1) For the violation of the provisions for labelling of medicinal products, a warning or a fine from ten to seventy-five units of fine shall be imposed on a natural person but a fine from one hundred to seven hundred and fifty units of fine on a legal person.

(2) For the distribution of medicinal products without the instructions for use (package leaflet) or with the instructions for use (package leaflet) that do not comply with the requirements of laws and regulations, a fine from ten to seventy-five units of fine shall be imposed on a natural person but a fine from one hundred to seven hundred and fifty units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 79. For the violation of the requirements for parallel import of medicinal products or procedures for parallel distribution of medicinal products, a fine from five to fifty units of fine shall be imposed on a natural person but a fine from fifty to five hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 80. (1) For the violation of the quality control procedures for medicinal products at a medicinal product wholesaler, a fine from five to sixty units of fine shall be imposed on a natural person but a fine from fifty to six hundred units of fine on a legal person.

(2) For the violation of the quality control procedures for medicinal products in the manufacturing of medicinal products, a fine from five to sixty units of fine shall be imposed on a natural person but a fine from fifty to six hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 81. For the violation of the regulations regarding the pricing of medicinal products, a fine from ten to seventy units of fine shall be imposed on a natural person but a fine from one hundred to seven hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 82. For the distribution of medicinal products to a person who is not entitled to purchase these medicinal products, a fine from twenty to seventy-five units of fine shall be imposed on a natural person but a fine from two hundred to seven hundred and fifty units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 83. For the failure to recall medicinal products from the market in the cases laid down in laws and regulations or for the violation of the procedures for recalling medicinal products, a fine from ten to eighty units of fine shall be imposed on a natural person but a fine from one hundred to eight hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 84. For the violation of pharmacovigilance regulations, a fine from ten to ninety units of fine shall be imposed on a natural person but a fine from one hundred to nine hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 85. For the carrying out of pharmaceutical activity without the involvement of a qualified person laid down in laws and regulations, a fine from fifty to one hundred units of fine shall be imposed on a natural person but a fine from five hundred to one thousand units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 86. For the distribution of medicinal products or active substances the expiry date of which has passed or the quality of which does not comply with the requirements of approved documentation of technical standards, a fine from fifty to one hundred and forty units of fine shall be imposed on a natural person but a fine from five hundred to one thousand and eight hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 87. For the distribution of medicinal products or active substances not allowed in the Republic of Latvia, a fine from thirty to one hundred and forty units of fine shall be imposed on a natural person but a fine from three hundred to two thousand units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 88. For the failure to perform a verification of the safety features of medicinal products or for the failure to perform the obligations laid down with regard to the verification system of medicinal products, a fine from thirty to two hundred and eighty units of fine shall be imposed on a natural person but a fine from three hundred to two thousand and eight hundred units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 89. (1) For the refusal to deliver medicinal products to a pharmacy if these medicinal products are in the stock of the medicinal product wholesaler, a fine from one thousand to four thousand units of fine shall be imposed on a legal person.

(2) For the failure to submit a request for the delivery of medicinal products to a medicinal product wholesaler in whose stock these medicinal products were at the given moment according to publicly available information, a fine from one thousand to four thousand units of fine shall be imposed on a legal person.

(3) For the violation of the prohibition to export or take out medicinal products, a fine from two hundred and fifty to four hundred units of fine shall be imposed on a natural person but a fine from two thousand and five hundred to four thousand units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 90. For the carrying out of activities that require a special permit (licence) without such a special permit (licence), a fine from two hundred to four hundred units of fine shall be imposed on a natural person but a fine from two thousand to four thousand units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 91. For importing, exporting or distribution of falsified medicinal products or falsified active substances, a fine from fifty to four hundred units of fine shall be imposed on a natural person but a fine from five hundred to four thousand units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 92. For the manufacturing or production of falsified medicinal products or falsified active substances, a fine from three hundred to four hundred units of fine shall be imposed on a natural person but a fine from three thousand to four thousand units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 93. (1) Administrative offence proceedings for the offences referred to in Sections 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, and 92 of this Law shall be conducted by the Health Inspectorate.

(2) The State Revenue Service shall also be entitled to conduct the administrative offence proceedings for the offences referred to in Sections 76, 79, 87, Section 89, Paragraph three, and Section 91 of this Law until the examination of the administrative offence case.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Chapter XII
Administrative Offences in the Field of Veterinary Medicinal Products and Competence in Administrative Offence Proceedings

[21 May 2020 / Chapter shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 94. (1) For dispensing prescription veterinary medicinal products without a veterinary prescription or without a written request from a practising veterinarian, or for dispensing to another person medicinal products which may be handled only by a practising veterinarian, a fine from fifty to two hundred and eighty units of fine shall be imposed on a legal person.

(2) For the distribution of veterinary medicinal products or active substances without the delivery documents laid down in laws and regulations, a fine from seven to fifty-six units of fine shall be imposed on a natural person but a fine from seventy to five hundred and sixty units of fine on a legal person.

(3) For the distribution of veterinary medicinal products without the labelling or instructions for use (package leaflet) laid down in laws and regulations, a fine from seven to fifty-six units of fine shall be imposed on a natural person but a fine from seventy to five hundred and sixty units of fine on a legal person.

(4) For the distribution of veterinary medicinal products the expiry date of which has passed, a fine from fourteen to one hundred and forty-two units of fine shall be imposed on a natural person but a fine from one hundred and forty to one thousand four hundred and twenty units of fine on a legal person.

(5) For the distribution of veterinary medicinal products which do not comply with the technical standards laid down in the registration documentation of the veterinary medicinal products or the quality or efficacy of which does not meet the requirements indicated in the veterinary prescription or a written request from a practising veterinarian, a fine from fourteen to one hundred and forty-two units of fine shall be imposed on a natural person but a fine from one hundred and forty to one thousand four hundred and twenty units of fine on a legal person.

(6) For the distribution of veterinary medicinal products not allowed in the Republic of Latvia, a fine from twenty-eight to one hundred and forty units of fine shall be imposed on a natural person but a fine from two hundred and eighty to one thousand four hundred and twenty units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 95. (1) For the use of ingredients of inadequate quality or efficacy in the production or manufacturing of veterinary medicinal products, a fine from two hundred and eighty to one thousand four hundred and twenty units of fine shall be imposed on a legal person.

(2) For the manufacturing of veterinary medicinal products or active substances without a certificate of good manufacturing practice for veterinary medicinal products, a fine from two hundred and eighty to one thousand four hundred and twenty units of fine shall be imposed on a legal person.

(3) For the manufacturing of veterinary medicinal products or active substances if the duties of a qualified person are performed by a person whose qualification or professional experience does not meet the requirements of laws and regulations, a fine from two hundred and eighty to one thousand four hundred and twenty units of fine shall be imposed on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 96. For the carrying out of activities that require a special permit (licence) without such a special permit (licence), a fine from twenty-eight to one hundred and forty units of fine shall be imposed on a natural person but a fine from two hundred and eighty to one thousand four hundred and twenty units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 97. (1) For the distribution of falsified veterinary medicinal products or falsified active substances, a fine from forty to three hundred units of fine shall be imposed on a natural person but a fine from four hundred to three thousand units of fine on a legal person.

(2) For the manufacturing or production of falsified veterinary medicinal products or falsified active substances, a fine from one hundred to four hundred units of fine shall be imposed on a natural person but a fine from one thousand to four thousand units of fine on a legal person.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Section 98. (1) The administrative offence proceedings for the offences referred to in Sections 94, 95, 96, and 97 of this Law shall be conducted by the Food and Veterinary Service.

(2) The State Revenue Service shall also be entitled to conduct the administrative offence proceedings for the offences referred to in Section 94, Paragraphs two and six, and Section 97, Paragraph one of this Law until the examination of the administrative offence case.

[21 May 2020 / This Section shall come into force on 1 July 2020. See Paragraph 28 of Transitional Provisions]

Transitional Provisions

1. [19 March 1998]

2. Permits (licences) for establishing (operating) pharmacies, which have been issued to medicinal product wholesalers or medicinal product manufacturing undertakings, and permits (licences) for pharmaceutical activities prior to the coming into force of this Law shall retain their period of validity.

3. Certification of pharmacies, medicinal product wholesalers and medicinal product manufacturing undertakings, and professional qualification certification of pharmacist shall be commenced after the issuance of relevant Cabinet regulations.

4. Section 6, Clause 6; Section 7, Clause 2 and Section 20, Clauses 4 and 5 of this Law shall be in force until 1 January 2000.

[17 December 1998]

5. Section 59, Clause 3 of this Law shall be in force until 1 January 2000.

[17 December 1998]

6. With the coming into force of this Law, Cabinet Regulation No. 101, Pharmacy Regulations, issued in accordance with the procedures laid down in Section 81 of the Constitution (Latvijas Republikas Saeimas un Ministru Kabineta Ziņotājs, 1996, No. 10), is repealed.

7. Section 39 of this Law shall be in force until 31 December 2004.

[19 March 1998]

8. Permits for the distribution of medicaments which were issued until 1 January 2000 pursuant to Section 6, Clause 6 of this Law shall be in force until 1 July 2000.

[1 June 2000]

9. Section 20, Clause 6 of this Law shall come into force on 1 January 2003.

[1 June 2000]

10. The branches of pharmacies which do not comply with the requirements laid down in Section 36 shall terminate their operations by 31 December 2000.

[1 June 2000]

11. The Cabinet shall, by 1 March 2002, issue regulations that regulate:

1) the procedures for conformity assessment of the pharmacies, medicinal product wholesalers and medicinal product manufacturing undertakings referred to in Section 5, Clause 1 of this Law;

2) the labelling of medicinal products referred to in Section 5, Clause 3 of this Law.

[14 June 2001]

12. The Cabinet shall, by 1 July 2002, issue regulations that regulate the requirements to be met by medicinal product instructions for use (package leaflet) referred to in Section 5, Clause 12 of this Law.

[14 June 2001]

13. The Cabinet shall, by 1 January 2002, issue regulations that regulate:

1) the procedures for conformity assessment of good distribution practices referred to in Section 5, Clause 14 of this Law;

2) the procedures for conformity assessment of good clinical practices referred to in Section 5, Clause 15 of this Law.

[14 June 2001]

14. [9 August 2010]

14.¹ Pharmacies which have received a licence for establishing (operation) of a pharmacy the term of validity of which terminates by 31 December 2010 and the operation of which does not conform to the requirements laid down in Section 36 of this Law have the right to receive an extension of licence until 31 December 2011.

[9 August 2010]

15. Until the establishment of the State agency State Agency of Medicines, the Minister for Health is the representative of the holder of the State capital shares in the Agency.

[16 April 2003]

16. The Cabinet shall, by 1 January 2004, issue regulations that regulate the procedures for the registration of pharmacists and pharmacist's assistants referred to in Section 5, Clause 17 of this Law.

[16 April 2003]

17. The coming into force of Section 17, Paragraph two, Section 22, Paragraph three, Section 25.¹, Section 31, Clause 7, Section 38, Paragraph three, Sections 46.¹ and 60.¹ shall be laid down by a special law.

[16 April 2003]

18. The repeal of Sections 46 and 60 of this Law shall be laid down by a special law.

[16 April 2003]

19. Permits for the management of pharmacies issued by the Ministry of Welfare up to 31 January 2003 are in effect until the end of the time period referred to in the permit.

[16 April 2003]

20. A pharmacist's assistant who has received a permit for the management of a pharmacy issued by the Ministry of Health, but does not conform to the requirements which in accordance with Section 39 of this Law are required by a manager from 1 July 2004, may manage a pharmacy until the end of the time period referred to in the permit.

[16 April 2003]

21. Section 39 of this Law is in force until 31 December 2010.

[16 April 2003]

22. By the day when the Cabinet Regulation referred to in Clause 1, Section 5 of this Law governing the procedures for issuing, suspending, re-registering and revoking special permits (licences) for pharmaceutical activities and of professional qualification certificates for pharmacists, as well as the requirements for commencement of operating and operating of pharmacies, medicinal product wholesalers and medicinal product manufacturing, and the procedures for conformity assessment, and the Cabinet Regulation referred to in Clause 14, Section 5 of this Law governing the procedures for evaluating conformity of distribution of medicinal products (except veterinary medicinal products) with the requirements of good distribution practices shall come into force, but not longer than until 1 April 2010 the following shall be applicable:

1) Cabinet Regulation No. 248 of 6 July 1999, Procedures for Certification of Professional Qualification of Pharmacists;

2) Cabinet Regulation No. 207 of 22 May 2001, Requirements for Opening and Operating of Pharmacies;

3) Cabinet Regulation No. 229 of 1 April 2004, Procedures for Issuance, Suspension, Re-registration and Revoking of Special Permits (Licences) for Veterinary Pharmaceutical Activities;

4) Cabinet Regulation No. 415 of 26 June 2007, Procedures for Issuance, Suspension, Re-registration and Cancellation of Special Authorisations (Licences) for Pharmaceutical and Veterinary Pharmaceutical Activities, Paying of State Fee for Issuance and Re-registration Thereof, as well as Conformity Assessment of Pharmacies, Medicinal Product and Veterinary Medicinal Product Wholesalers and Medicinal Product and Veterinary Medicinal Product Manufacturing Undertakings and Goods Distribution Practices of Medicinal Products, in so far as they are not in contradiction to this Law.

[23 October 2008; 12 March 2009]

23. By the day when the Cabinet Regulation referred to in Clause 15, Section 5 of this Law governing the procedures for evaluating conformity of clinical research of medicinal products (except veterinary medicinal products) with the requirements of good clinical practices shall come into force, but no longer than until 1 April 2010 the Cabinet Regulation No. 172 of 28 February 2006, Regulations Regarding the Conduct of Clinical Trials and Non-interventional Trials, the Procedures for the Labelling of Investigational Medicinal Products and the Procedures for Inspection of Conformity with the Requirements of Good Clinical Practice shall be applicable insofar as they are not in contradiction to this Law.

[23 October 2008; 12 March 2009]

24. The new wording of Section 36, Section 38, Paragraph 1.¹ of this Law, and amendments to Section 42 in respect of the replacement of the words and figure "rural area, where 5" with the words and figure "in a municipality, municipality town or municipality rural territory where the number of inhabitants does not exceed 4000 and (..) five" shall come into force on 1 January 2011.

[9 August 2010]

25. A person who is distributing veterinary medicinal products in a pharmacy which has started operation thereof until 31 December 2010 is entitled to distribute veterinary medicinal products without a certificate for the distribution of veterinary medicinal products until 1 July 2012.

[28 October 2010]

26. The Cabinet shall, by 31 January 2013, make amendments to Cabinet Regulation No. 758 of 4 October 2011, Procedures for Issuing, Revoking and Extending the Term of Validity of a Certificate for Distribution of Veterinary Medicinal Products and for Registering the Certified Person, laying down the procedures by which assessment of qualification shall be performed.

[29 November 2012]

27. Section 10, Clause 1.¹ of this Law shall come into force on 1 July 2013.

[29 November 2012]

28. The new wording of the title of Chapter IX of this Law, the amendment regarding the deletion of Section 63 of this Law, and Chapters XI and XII of this Law shall come into force concurrently with the Law on Administrative Liability.

[21 May 2020]

29. Amendment to Section 2, Section 35, Paragraph one, Clause 4, and Section 48, Paragraph one of this Law, and also amendment regarding the supplementation of the Law with Chapter X.¹ in respect of the activities of the National Armed Forces in the field of pharmaceuticals and trade of means of medical treatment within the National Armed Forces shall come into force on 1 April 2022.

[9 December 2021]

30. The Health Inspectorate shall, by 2 May 2022, inspect the warehouse of means of medical treatment of the National Armed Forces and issue an inspection report if the warehouse of the National Armed forces conforms with the requirements of the laws and regulations regulating the field of pharmaceuticals.

[9 December 2021]

31. Until the day of coming into force of the Cabinet regulations referred to in Section 5, Clause 18 of this Law, but not later than until 31 May 2022, Cabinet Regulation No. 258 of 5 April 2011, Procedures by which a Veterinary Medical Care Institution and a Practising Veterinarian Purchase, Store, Record, and Use Medicinal Products, shall be applicable insofar as it is not in conflict with this Law.

[9 December 2021]

32. Clinical trials of medicinal products may be conducted if the sponsor of the clinical trial of medicinal products has a valid civil liability insurance contract concluded before the date of entry into effect of Section 26.³ until the end of the time period specified in the relevant contract.

[20 April 2023]

33. Amendments regarding the new wording of Sections 45 and 51 of this Law shall come into force on 1 August 2024. The special permit (licence) issued to the medicinal product wholesaler and medicinal product manufacturer referred to in Sections 45 and 51 of this Law for the opening (operating) of a medicinal product wholesaler and the manufacturing of veterinary medicinal products and also the special permit (licence) for the manufacturing of the hospital exemptions shall remain valid until 31 July 2024.

[20 June 2024]

34. The State Agency of Medicines shall issue the special permits (licences) for pharmaceutical activities referred to in Sections 45.¹ and 51.² of this Law, specifying the relevant veterinary pharmaceutical activity, namely the manufacturing or importing of veterinary medicinal products, or the distribution of veterinary medicinal products, as the special field of activity, to the manufacturers and importers of medicinal products, and medicinal product wholesalers referred to in Sections 45.¹ and 51.² of this Law, and also the certificates of good manufacturing practice referred to in Section 10, Clause 12.¹ of this Law in respect of the verifications of manufacturing or importing of veterinary medicinal products to the manufacturers and importers referred to in Section 51.² of this Law until 31 December 2024.

[20 June 2024]

35. The State Agency of Medicines shall, by 31 December 2024, hand over the matters related to the issuance of special permits (licences) and certificates in the field of veterinary medicinal products to the Food and Veterinary Service.

[20 June 2024]

36. Amendments regarding the new wording of Section 10, Clause 7 of this Law and the deletion of Clause 7.¹, and also amendment to Section 26.¹, Paragraph five of this Law shall enter into force on 1 July 2025.

[20 June 2024]

37. The Cabinet shall, by 1 July 2025, issue the regulations referred to in Section 5, Clauses 1.¹ and 19.¹, Section 17, Paragraphs two and five, Section 25.⁴, Paragraphs two and three, Section 25.⁶, Section 32.¹, Paragraph three, Section 32.², Paragraph two, Section 35, Paragraph four, Section 41, Paragraph two, Section 42, Section 48, Paragraph 1.³, Section 51, Paragraph nine, Section 51.³, Paragraph two, and Section 52.¹, Paragraph four of this Law. Until the day of coming into force of the relevant Cabinet regulations, but not longer than until 30 June 2025, Cabinet Regulation No. 800 of 19 October 2011, Procedures for Licensing Pharmaceutical Activities, shall be applicable insofar as it is not in conflict with this Law.

[20 June 2024]

Informative Reference to European Union Directives

[29 November 2012; 20 April 2023]

This Law contains legal norms arising from:

1) 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;

2) 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;

3) [20 April 2023];

4) Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;

5) 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.

The Law has been adopted by the Saeima on 10 April 1997.

President G. Ulmanis

Rīga, 24 April 1997

¹ The Parliament of the Republic of Latvia

Translation © 2025 Valsts valodas centrs (State Language Centre)