Cabinet of Ministers Regulation No. 537
Riga, 31st July 2012 (protocol No. 42, §50)
I. General Provisions
1. The State Agency of Medicines (hereinafter - Agency) shall be a state institution subjected to the Minister of Health. The Minister of Health implements the supervision of the Agency through the Ministry of Health.
2. The operational objective of the Agency shall be to implement qualitative and valid services in the evaluation of medicinal products used in health care, procurement and storage organisations of human blood, tissues, cells and organs, as well as pharmaceutical activity companies in accordance with the interests of the state and the public in the field of health care.
II. Functions, Tasks and Competence of the Agency
3. The Agency shall carry out the functions stated in the Pharmaceutical Law, the Law "On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products", the Law On Precursors and other normative acts by providing services to private individuals, state and local government institutions and foreign institutions.
4. The Agency shall carry out the following tasks:
4.1. evaluate and authorise medicinal products, carry out quality expertise of medicinal products, prepare and update the Drug Register of the Republic of Latvia;
4.2. carry out pharmacovigilance;
4.3. issue licences for conduct of clinical trials with medicinal products, evaluate the compliance of medicinal product clinical trials with the requirements of Good Clinical Practice, as well as evaluate the applications for non-interventional trials with medicinal products;
4.4. issue licences for import, export, transit, distribution and purchase (to ensure operation) of medicinal products, as well as issue permits for the use of plants, substances and medicinal products included in the lists of narcotic substances, psychotropic substances and precursors for medical and veterinary medical scientific research, for the determination of physical and chemical properties and for educational purposes;
4.5. regularly collect and distribute information regarding consumption of medicines;
4.5.1 evaluate cost-effectiveness of medical technologies;
4.6. issue precursor operator cards and special permits (licences) for operating with precursors;
4.7. authorise medical devices manufactured in Latvia, issue licences for distribution of specially delivered medical devices, as well as carry out medical devices vigilance;
4.7.1 approve medical technologies utilised in healthcare, register approved medical technologies, create and maintain record of approved medical technology and database of medical technology reimbursed from state budget;
4.8. issue licences for conduct of clinical trials with medical devices;
4.9. issue compliance certificates to procurement and storage institutions of human tissues, cells, and organs, blood establishments, blood banks and the State Blood Donor Center;
4.10. issue special permits (licences) for pharmaceutical activity;
4.11. issue Good Manufacturing Practice compliance certificates for medicinal products;
4.12. participate in the joint systems of the state agencies of medicinal products and medical devices within the European Economic Area, collaborate with European institutions and international organisations by participating in work sharing, complying with unified standards and procedures;
4.13. collaborate with professional organisations of medical doctors and pharmacists, non-governmental organisations, foreign and international organisations in the field, as well as ensure exchange of information between operational areas of the Agency;
4.14. carry out the tasks of the competent authority determined by:
4.14.1. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31st 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;
4.14.2. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12th December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004;
4.14.3. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13th November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004;
4.14.4. Commission Regulation (EC) No 1234/2008 of 24th November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products;
4.14.5. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15th December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and Regulation (EC) No 1394/2007 on advanced therapy medicinal products;
4.14.6. Commission Implementing Regulation (EU) No 520/2012 of 19th June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council;
4.15. carry out tasks determined by other normative acts.
5. The Agency has the right to:
5.1. request and receive free of charge the information necessary for implementation of Agency functions and tasks from the state and local government institutions, as well as natural and legal persons as determined by the procedures of the normative acts ;
5.2. collect payment for the public services provided by the Agency in the amount determined by the Cabinet of Ministers;
5.3. involve experts, as well as establish expert councils and commissions in order to implement Agency functions;
5.4. according to the area of operation organise conferences, seminars, courses, training and other educational and informative events;
5.5. according to the competence of the Agency sign contracts with state and local government institutions, non-governmental institutions, natural and legal persons, as well as foreign institutions and international organisations.
III. Agency Administration, Mechanism for Ensuring and Supervising Legal Operation of the Agency
6. The Director of the Agency shall be a civil servant of the state appointed and removed from office by the Minister of Health.
7. The Director of the Agency may have deputies - civil servants of the state.
8. The decisions and actual actions of the employees of the structural units of the Agency may be contested by submitting a corresponding application to the Director of the Agency. The decision of the Director of the Agency may be contested in the administrative Court.
9. The administrative acts (except the decision mentioned in Article 8 of this Regulation) issued by the Director of the Agency and the actual actions of the Director of the Agency may be contested in the Ministry of Health. The decisions of the Ministry of Health may be contested in the administrative Court.
10. The Agency shall prepare and submit to the Ministry of Health regular and annual review of its operation and utilisation of its financial resources.
11. Upon request from the Ministry of Health the Agency shall provide information regarding the operation of the Agency and utilisation of its financial resources.
IV. Closing Provisions
12. The Cabinet of Ministers 7th December 2004 Regulation No. 1006 "The By-Laws of the State Agency of Medicines" (Latvijas Vēstnesis, 2004, No. 196; 2005, No. 172; 2009, No. 157) is repealed.
13. This Regulation shall come into force on 1st January 2013.
Prime Minister V. Dombrovskis
Minister of Health I. Circene
11.07.2019 No. 1-16/2
Regulation of the State Agency of Medicines
Issued in accordance with
Section 75, Paragraph 1 of
the State Administration Structure Law
I. General Provision
1. The Regulation of the State Agency of Medicines (hereinafter – Regulation) stipulates the structure (hereinafter – structure) and work management of the State Agency of Medicines (hereinafter – Agency).
2. The Agency shall perform the functions and tasks stipulated by the State Administration Structure Law, statutes of the Agency, other normative acts and this Regulation.
II. Structure of the Agency
3. The structure of the Agency is stipulated by this Regulation, regulations of structural units and the list of offices of the Agency.
4. The Director of the Agency (hereinafter – Director) is the highest ranking official in the Agency. The Director is directly subordinate to the Minister for Health.
5. The Deputy Director is directly subordinate to the Director. A civil servant or employee of the Agency whose office is not incorporated in any department, division or sector is directly subordinate to the Director in accordance with the list of offices of the Agency.
6. The structural units of the Agency consist of departments, divisions, sectors and the laboratory:
6.1. Directly subordinate to the Director:
6.1.1. Medicines Marketing Authorisation Department and its divisions and sectors;
6.1.2. Clinical Trials Department;
6.1.3. Health Technology Assessment Department;
6.1.4. Administrative Department and its sectors;
6.1.5. Financial Accounting, Analysis and Planning Department;
6.1.6. Information Technologies and System Development Department;
6.1.7. Legal Department;
6.1.8. Public Relations Department.
6.2. Directly subordinate to the Deputy Director of the Agency:
6.2.1. Pharmaceutical Activities Compliance Evaluation Department;
6.2.2. Pharmaceutical Activities Company Licensing Department;
6.2.3. Medical Devices Assessment Department;
6.2.4. Information on Medicines Distribution Department;
6.2.5. Medicines Examination Laboratory.
III. Work Management of the Agency
7. The work of the Agency shall be managed by the Director who shall:
7.1.1. Plan, manage and coordinate the work of Agency and ensure its legality;
7.1.2. Ensure the establishment of midterm operational strategy, annual work plan and draft budget, as well as completion of the approved work tasks within the established budget;
7.1.3. Ensure preparation of proposals and opinions regarding policy documents;
7.1.4. Operate with the financial resources of the Agency and be responsible for their use;
7.1.5. Represent the Agency without special authorisation;
7.1.6. Appoint, hire and release from employment all Agency employees and civil servants;
7.1.7. May give direct orders and assign tasks to any Agency employee or civil servant;
7.1.8. May delegate an employee or civil servant to sign documents on behalf of the Agency with an order, authorisation letter or contract;
7.1.9. Continuously adopt decisions regarding issues in the competence of the Agency, shall abolish or amend orders issued or decisions adopted by the Deputy Director, Heads of structural units and other civil servants and employees of the Agency;
7.1.10. Provide information within their competence regarding issues in the competence of the Agency and communicate with other state administration institutions, European Union institutions, professional associations of doctors and pharmacists, non governmental organisations in the field, legal entities and natural persons;
7.1.11. Issue orders for establishment of commissions and working groups for performance of specific tasks;
7.1.12. May invite representatives of other institutions or natural persons to participate in commissions and working groups and to be included in the relevant commission or working group for performance of specific tasks as experts in the relevant industry or field.
8. The competence, duties, rights and responsibilities of the Director are laid down in the State Administrative Procedure Law, Public Agencies Law, Cabinet of Ministers Regulation No. 537 of 31 July 2012 “The Statutes of the State Agency of Medicines”, other normative acts and in the job description.
9. The competence, duties, rights and responsibilities of the Deputy Director, Heads of structural units, other employees and civil servants are laid down in job descriptions.
10. In the absence (temporary disability, vacation, business trip, etc.) of the Director of the Agency, an Agency official is appointed as Acting Director by order of the Ministry of Health in accordance with Director’s proposal.
11. The Deputy Director shall:
11.1. According to his/her competence, plan, manage, organise and coordinate the work of Agency’s structural units under his/her direct subordination, and assign tasks to the Heads, employees and civil servants of these structural units, as well as cooperate with other structural units of the Agency;
11.2. Within his/her competence, ensure implementation of normative acts and orders of the Director of Agency;
11.3. Submit proposals to the Director regarding management of Agency’s structural units and work, appointment and termination of service of civil servants, appointment and termination of employment of employees, work results, distribution of job responsibilities, motivation, raising of qualification, as well as enforcing disciplinary responsibility.
11.4. According to his/her competence, represent the Agency in relations with other state administration institutions, European Union institutions, competent authorities in other countries and international organisations, professional associations of doctors and pharmacists, non-governmental organisations in the field, and natural persons;
12. The Heads of structural units of the Agency shall:
12.1. Ensure implementation of normative acts and orders of the Director and Deputy Director according to the competence of the structural unit;
12.2. Plan, manage, organise and coordinate the work of structural units, as well as supervise completion of tasks assigned to the structural unit and ensure internal process control;
12.3. Evaluate operational results of the structural unit and provide information to the Director or Deputy Director;
12.4. According to the competence of the structural unit, prepare proposals for improvements to normative acts regulating the pharmaceutical field;
12.5. Within the competence of the structural unit, ensure preparation of administrative acts, administrative decisions and internal normative acts;
12.6. Ensure structural unit cooperation with other structural units of the Agency, state administration institutions, professional associations of doctors and pharmacists non-governmental organisations in the field, natural persons and international institutions according to the competence of and tasks assigned to the structural unit;
12.7. According to the competence of the structural unit, prepare proposals for the midterm strategy and work plan of the Agency, ensure and control the completion of tasks assigned to the structural unit in the work plan, as well as prepare information for the quarterly and annual report, and public report of the Agency;
12.8. According to the competence of the structural unit, ensure provision of opinion regarding documents, internal normative acts and draft decisions prepared by other structural units of the Agency;
12.9. Submit to the Director proposals for organisation of Agency structural units and work management, appointment and termination of service of civil servants, appointment and termination of employment of employees, work results, distribution of job responsibilities, motivation, raising of qualification, as well as enforcing disciplinary responsibility;
12.10. Determine obligations and level of responsibility of structural unit employees and civil servants, and, after receiving approval from the direct supervisor, submit job descriptions of employees and civil servants to the Director for approval.
13. Heads of structural units of the Agency may have Deputies, whose competence is laid down in job description.
14. Procedure for work management issues not reflected in this Regulation is laid down in internal normative acts of the Agency.
15. Commission work organisation, tasks and rights are laid down in their regulation. The list of members and tasks of working groups are stipulated by an order of the Director.
IV. General Competence of the Structural Units of the Agency
16. The Medicines Marketing Authorisation Department shall evaluate the compliance of medicinal product marketing authorisation documentation with the requirements of normative acts and shall ensure marketing authorisation of medicinal products, renewal of marketing authorisation and approval/refusal of variations to marketing authorisation documentation, conduct pharmacovigilance, create and regularly update the Medicinal Product Register of Latvia, as well as evaluate compliance of products with the definition of a medicinal product upon request.
17. The Medical Devices Evaluation Department shall:
17.1. Receive, review and store information in the medical device database of Latvia regarding:
17.1.1. Manufacturers of Class I and in vitro diagnostic medical devices, collectors of system and procedure packs and manufacturers of custom manufactured medical devices, who have registered their business operation in the Republic of Latvia, and the medical devices they manufacture;
17.1.2. Authorised representatives with registered business operation in the Republic of Latvia, representing manufacturers that have not registered their business operation in any European Union member state or European Economic Area country;
17.1.3. Notified class II a, II b and III medical devices, List A, List B and self testing in vitro diagnostic, as well as active implantable medical devices released on the market in the Republic of Latvia;
17.2. Ensure issuance of authorisations for conduct of clinical trials with medical devices;
17.3. Ensure issuance of permits for dispensation of specially supplied medical devices without CE marking;
17.4. Ensure issuance of certificates of free sale for medical devices with CE marking manufactured in the Republic of Latvia;
17.5. Perform medical device vigilance.
18. The Health Technology Assessment Department shall ensure assessment and registration of medical technologies utilised in healthcare, as well as evaluation of cost effectiveness of medicinal products, medical devices and medical technologies utilised in healthcare.
19. The Clinical Trials Department shall evaluate the compliance of clinical trial project documentation with requirements of normative acts and ensure issuance of authorisations for initiation of clinical trials in Latvia, perform monitoring of clinical trials with medicinal products conducted in Latvia, evaluate their compliance with requirements of good clinical practice, evaluate applications for non interventional studies with medicinal products and ensure their registration at the Agency, as well as evaluate reports submitted in the EUdraVigilance database regarding serious adverse reactions to investigational medicinal products observed in clinical trials conducted in Latvia and evaluate annual safety reports for investigational medicinal products.
20. The Pharmaceutical Activities Compliance Evaluation Department shall:
20.1. Evaluate and inspect compliance of medicinal product, active substance and excipient manufacturers and importers with requirements of good manufacturing practice, and ensure issuance of good manufacturing practice certificates;
20.2. Evaluate and inspect compliance of medicinal product wholesalers, active substance distributors, importers and brokers with requirements of good distribution practice, and ensure issuance of good distribution practice certificates;
20.3. Evaluate and inspect compliance of tissue centres, tissue, cell and organ procurement establishments, transplantation centres, as well as compliance of sites utilising tissues, cells, organs and bodies of deceased human beings for the implementation of an accredited medical studies program at a higher education institution, conduct compliance evaluation and monitoring of hospital blood establishments, blood banks and the State Blood Donor Center, and ensure appropriate control measures to ensure quality of blood and blood components and procedures for haemovigilance.
21. The Pharmaceutical Activities Company Licencing Department shall:
21.1. Review and verify compliance of pharmaceutical activity company documentation with requirements of normative acts and ensure issuance of special permits (licences) for pharmaceutical activity, including veterinary pharmaceutical activity (for manufacturing, import and wholesale distribution of narcotic and psychotropic veterinary medicinal products);
21.2. Ensure registration of active substance manufacturers, importers, distributors and brokers, and issuance of registration certificates.
22. The Medicines Examination Laboratory shall ensure expertise on quality of medicinal product samples obtained in pharmacies, selection and testing of samples, preparation of titrated solutions, indicators and reagents upon request from pharmacies.
23. The Information on Medicines Distribution Department shall:
23.1. Ensure issuance of permits for import, export, transit, distribution and purchase (to ensure own operation) of medicinal products, as well as for use of herbs, substances and medicinal products included in the lists of narcotic substances, psychotropic substances and precursors controlled in Latvia in medical and veterinary medical scientific studies, testing of physical and chemical properties and for training;
23.2. Ensure issuance of precursor operator registration cards and special permits (licences) for operation with precursors;
23.3. Ensure collection, analysis and distribution of statistics on medicinal product consumption, data on medicinal product availability and prices.
24. Administrative Resources and Documents Management Department shall ensure human resources management processes, as well as management of estate and property.
25. The Financial Accounting, Analysis and Planning Department shall conduct financial analysis, budget planning and prepare the annual draft budget of the Agency, keep Agency’s financial records, ensure internal control of accounting processes in the Agency with regard to utilisation of Agency’s material, human and financial resources and maintenance of Agency’s property.
26. The Information Technologies and System Development Department shall organise rational and purposeful use and development of material and technical resources of the Agency in the field of information technology, as well as ensure continuous functionality of Agency’s information systems and data transmission network, and protection of the data therein.
27. The Legal Department shall ensure legal support for Agency’s structural units in the field of operation of the Agency, as well as conduct legal review of issues in the competence of the Agency and provide solutions.
28. The Public Relations Department shall ensure internal and external communication activities regarding functions and tasks in the competence of the Agency.
29. In accordance with with common standards and procedures the structural units of the Agency shall cooperate with competent authorities for medicinal products and medical devices in European Union member states and European Economic Area countries, as well as participate in the work of European institutions and international organisations by participating in the performance of specific tasks.
V. Verification of Administrative Decisions
30. Preliminary basic verification of the expediency and legality of administrative decisions adopted by the Agency (administrative act, order, etc.) shall be conducted by the person preparing the draft decision and the relevant superior official by issuing a visa (approval) for the draft, as well as the person adopting the decision by signing the decision.
31. Additional verification of the legality of administrative decisions in the Agency shall be conducted by the Legal Department or an official appointed by the Director of Agency who shall evaluate compliance with normative acts and general legal principles, as well as state administration principles.
32. Incidental (regarding the case in question), random and regular subsequent verification of administrative decisions in the Agency shall be conducted by the Monitoring Auditor or Agency’s civil servant or employee appointed by the Director of Agency.
VII. Closing Provisions
33. Repeal the Regulation of the Agency No. 1-10/7 of 24 July 2014 “Regulation of the State Agency of Medicines.
34. This Regulation shall come into force on 11 July 2019.
Approved by the Minster for Health on 9 July 2019 (Letter No. 01 16.1/2912 from the Ministry of Health “Regarding Approval of Draft Regulation of the State Agency of Medicines”)
Director Svens Henkuzens