Statute
Regulation No 537 of the Cabinet of Ministers of the Republic of Latvia ''By-laws of the State Agency of Medicines'' adopted on 31 July 2012.
Regulations
Regulation of the State Agency of Medicines
In Riga
15.11.2023 No 1-16/12
Issued in accordance with
Section 73, Paragraph 1, Clause 1
of the State Administration Structure Law
I. General Provisions
1. The Regulation of the State Agency of Medicines (hereinafter – Regulation) stipulates the composition (hereinafter – structure) and work organisation of the State Agency of Medicines (hereinafter – Agency), as well as the competency of Agency’s structural units.
2. The Agency performs the functions stipulated by the State Administration Structure Law, Public Agencies Law, statutes of the Agency, other normative acts and tasks stipulated by this Regulation.
II. Structure of the Agency
3. The structure of the Agency is stipulated by an order issued by the director.
4. The director of the Agency (hereinafter – director) is the highest ranking official at the Agency. The director is directly subordinate to the Minister for Health.
5. Deputy director in pharmaceutics and deputy director for evaluation of medicines (hereinafter together – deputy directors) are directly subordinate to the director. Any Agency official or employee whose job position is not included in a structural unit of the Agency, is directly subordinate to the director.
6. The following structural units are included in the structure of the Agency:
6.1. Directly subordinate to the director:
6.1.1. Medicines Safety Division and its sector;
6.1.2. Financial Accounting, Analysis and Planning Division;
6.1.3. Legal Division;
6.1.4. Public Relations Division;
6.1.5. Strategic Management and Administrative Resources Department and its divisions.
6.2. Directly subordinate to the deputy director in pharmaceutics:
6.2.1. Compliance Assessment Division;
6.2.2. Pharmaceutical Activity Licensing Division;
6.2.3. Medical Devices Division;
6.2.4. Health Technology Assessment Division;
6.2.5. Medicines Distribution Information Department and its divisions.
6.3. Directly subordinate to the deputy director for evaluation of medicines:
6.3.1. Primary Expertise and Procedure Coordination Division and its sector;
6.3.2. Deleted by amendment Nr.1-16/3 of 13.08.2024;
6.3.3. Clinical Studies Division;
6.3.4. Medicines Examination Laboratory;
6.3.5. Medicines Marketing Authorization Department and its divisions and sectors.
III. Work Organization of the Agency
7. The work of the Agency is managed by the director who is responsible for the following:
7.1. Planning, management and coordination of Agency’s work and ensuring its lawfulness;
7.2. Ensuring development of Agency’s mid-term operational strategy, annual work plan and budget draft and achievement of approved operational tasks within the stipulated budget;
7.3. Ensuring preparation of proposals and opinions for policy documents;
7.4. Operating with Agency’s financial resources and assuming responsibility for their spending;
7.5. Representing the Agency without special authorisation;
7.6. Appointing, initiation and termination of the employment of all employees and civil servants at the Agency;
7.7. The director may give direct orders and tasks to any employee or civil servant of the Agency;
7.8. The director may give authorisation to sign documents on behalf of the Agency to a civil servant or employee of the Agency with an order, authorisation letter or agreement;
7.9. Making decisions regarding issues in the Agency’s competency, annulment of or amendments to orders issued or decisions made by deputy directors, heads of structural units and other civil servants and employees of the Agency;
7.10. Providing information within their competence regarding issues in the competence of the Agency and communicating with other state administration institutions, European Union institutions, competent authorities of other countries, professional organisations of doctors and pharmacists, non-governmental organisations in the field, legal entities and natural persons;
7.11. Issuing orders for establishment of commissions and working groups for the performance of specific tasks;
7.12. The director may invite representatives of other institutions or natural persons to participate in commissions and working groups and 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 Administration Structure 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 directors, heads of structural units, other employees and civil servants are laid down in their respective job descriptions.
10. Work organisation, tasks and rights of the commissions are laid down in their regulation. The members and tasks of the working group are stipulated in an order issued by the director.
11. In the absence (temporary disability, vacation, official travel , etc.) of the director of the Agency, a civil servant of the Agency shall be appointed as acting director by order of the Ministry of Health.
12. The deputy director shall:
12.1. According to their competence, plan, manage, organise and coordinate the work of Agency’s structural units under their 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;
12.2. According to their competence, ensure implementation of normative acts and orders of the director of Agency;
12.3. Submit proposals to the director regarding management of Agency’s structural units and work, civil servant appointment and termination of service, employee appointment and termination of employment, work results, distribution of job responsibilities, motivation, raising of qualification, as well as enforcing disciplinary responsibility.
12.4. According to their competence, represent the Agency in relations with other state administration institutions, European Union institutions, foreign competent authorities and international organisations, professional associations of doctors and pharmacists, non‑governmental organisations in the industry, and natural persons.
13. Head of Agency’s structural unit (head of department, head of division and head of laboratory) shall:
13.1. Ensure implementation of normative acts and orders of the director and deputy director according to the competence of the structural unit;
13.2. 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;
13.3. Evaluate operational results of the structural unit and provide information to the director or deputy director;
13.4. According to the competence of the structural unit, prepare proposals for improvements to normative acts regulating the pharmaceutical field;
13.5. Within the competence of the structural unit, ensure preparation of administrative acts, administrative decisions and internal normative acts;
13.6. 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;
13.7. 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 annual report and public report of the Agency;
13.8. 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;
13.9. Submit to the director proposals for organisation of Agency’s structural units and work management, civil servant appointment and termination of service, employee appointment and termination of employment, work results, distribution of job responsibilities, motivation, raising of qualification, as well as enforcing disciplinary responsibility;
13.10. 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.
14. Head of a structural unit of the Agency may have a deputy, whose competence is laid down in the job description.
15. Procedure for work management issues not stipulated by this Regulation is laid down in internal normative acts of the Agency.
IV. General Competence of the Structural Units of the Agency
16. The Medicines Marketing Authorization Department:
16.1. Performs scientific expertise on medicinal product marketing authorization documentation and evaluates its compliance with the requirements of normative acts, and ensures marketing authorization, renewal and approval/rejection of variations to marketing authorization documentation of medicines, based on the scientific evaluation of documentation;
16.2. Upon request, evaluates product compliance with the definition of a medicinal product laid down in the Pharmaceutical Law;
16.3. Establishes medicinal product status as a non‑prescription or prescription medicinal product;
16.4. Upon request, provides scientific consultations regarding scientific and regulatory aspects of medicines;
16.5. Evaluates safety and effectiveness of therapies of substances of human origin in accordance with the requirements of normative acts.
17. Medicines Safety Division:
17.1. Performs safety monitoring of medicines, approves risk minimisation measures for medicines;
17.2. Evaluates pharmacovigilance aspects of periodic safety update reports and marketing authorization documentation;
17.3. Registers and evaluates possible adverse drug reactions, as well as other information regarding safety issues of medicines;
17.4. Evaluates compliance of marketing authorization holders with good pharmacovigilance practice;
17.5. Evaluates potential causal relationship between a patient’s adverse reaction and a COVID-19 vaccine;
17.6. Prepares information for communication with healthcare professionals and the public;
17.7. Evaluates compliance of applications for compensation for established severe or moderate harm to health or life caused by confirmed adverse drug reactions to the COVID-19 vaccines with the requirements of normative acts, determines the amount of the compensation in accordance with the requirements of normative acts and ensures awarding and payment of the compensation.
18. Primary Expertise and Procedure Coordination Division performs primary expertise on medicinal product marketing authorization, renewal and variations documentation, ensures coordination of evaluation procedures for medicines, issues certificates for medicinal product export in accordance with the requirements of normative acts, ensures documentation management of the Medicines Marketing Authorization Department and Medicines Safety Division, maintains and regularly updates the Medicinal Product Register of Latvia.
19. Clinical Studies Division evaluates compliance of medicinal product clinical trial project documentation with the requirements of normative acts and issues authorisations for initiation of clinical trials in Latvia, monitors clinical trials with medicines conducted in Latvia, evaluates their compliance with the requirements of good clinical practice, evaluates applications for non‑interventional studies, as well as evaluates reports recorded in the EudraVigilance database about suspected unexpected serious adverse reactions to investigational medicinal products and annual safety reports, if Latvia is the safety assessing member state for the relevant active substance.
20. The Medicines Examination Laboratory ensures 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.
21.Medicines Distribution Information Department:
21.1. Ensures issuance, suspension and annulment of permits for import, export, transit, distribution and acquisition (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 and industrial use;
21.2. Ensures issuance, suspension and annulment of precursor operator registration cards and special permits (licences) for operation with precursors;
21.3. Ensures collection, analysis and distribution of statistics on medicinal product consumption, data on medicinal product availability and prices;
21.4. Ensures extraction, collection, processing, analysis of data on effective and safe use of medicines pre-authorisation and post-authorisation period, performs impact analysis of regulatory decisions on the use and availability of medicines, prepares overviews and data visualisations, prepares information for communication with healthcare professionals and the public;
21.5. Creates and maintains a list of medicines with export restrictions in place, as well as analyses trends in the distribution of these medicines.
22. Pharmaceutical Activity Licensing Division:
22.1. Reviews and verifies compliance of documentation of pharmaceutical activity subjects with the requirements of normative acts and ensures issuance, renewal, suspension and annulment of special permits (licences) for pharmaceutical activity, including veterinary pharmaceutical activity (for manufacturing, import and wholesale distribution of narcotic and psychotropic veterinary medicinal products);
22.2. Ensures registration of active substance manufacturers, importers, distributors and brokers, and issuance of registration certificates;
22.3. Prepares and maintains information regarding pharmaceutical activity subjects.
23. Compliance Assessment Division:
23.1. Evaluates and inspects compliance of medicinal product, active substance and excipient manufacturers and importers with requirements of good manufacturing practice, and ensures issuance of good manufacturing practice certificates;
23.2. Evaluates and inspects compliance of medicinal product wholesalers, active substance distributors, importers and brokers with requirements of good distribution practice, and ensures issuance of good distribution practice certificates;
23.3. Evaluates and inspects compliance of tissue establishments , 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 blood transfusion rooms of medical treatment institutions , blood preparation divisions and the State Blood Donor Center, and ensures appropriate control measures to ensure quality of blood and blood components and procedures to monitor haemovigilance.
24.1. Receives, reviews and stores the following information in the electronic database of the medical device register LATMED:
24.1.1. Regarding manufacturers of Class I and in vitro diagnostic medical devices, system and procedure set acquirers whose site of commercial activity is registered in the Republic of Latvia, and the medical devices and in vitro diagnostic medical devices they manufacture;
24.1.2. Regarding authorised representatives with a registered site of commercial activity in the Republic of Latvia, representing manufacturers that have not registered their commercial activity in any European Union member state or European Economic Area country;
24.1.3. Regarding notified class II a, II b and III medical devices, class B, C and D, List A, List B and self‑testing in vitro diagnostic medical devices released on the market in the Republic of Latvia, as well as distributors of medical devices and in vitro diagnostic medical devices;
24.1.4. Regarding medical devices and in vitro diagnostic medical devices manufactured by healthcare institutions;
24.1.5. Regarding distributors or importers of medical devices and in vitro diagnostic medical devices for relabelled or repackaged medical devices and in vitro diagnostic medical devices released on the market in Latvia;
24.2. Ensures issuance of authorisation for conduct of clinical trials with medical devices and performance studies of in vitro diagnostic medical devices, as well as for substantial amendments to the aforementioned trials;
24.3. Ensures issuance of authorisation for release on the market or commissioning of medical devices and in vitro diagnostic medical devices for which the compliance evaluation procedures stipulated by normative acts have not been conducted;
24.4. Ensures issuance of certificates of free sale for medical devices and in vitro diagnostic medical devices labelled with a CE compliance mark and manufactured in the Republic of Latvia or whose manufacturer does not have a site of commercial activity in any European Union member state or European Economic Area country, but their authorised representatives have registered their commercial activity in the Republic of Latvia;
24.5. Performs vigilance of medical devices and in vitro diagnostic medical devices;
24.6. Ensures establishment and issuance of the single registration (identification) numbers intended for merchants and clinical trials, as well as performance studies in the field of medical devices and in vitro diagnostic medical devices.
25. The Health Technology Assessment Division ensures assessment, approval, review, supplementation and annulment of medical technologies utilised in healthcare, as well as evaluation of the cost‑effectiveness of medicinal products, medical devices and medical technologies utilised in healthcare.
26. Deleted by amendment Nr.1-16/3 of 13.08.2024;
27. Strategic Management and Administrative Resources Department:
27.1. Coordinates planning and achievement monitoring of strategic goals, tasks and outcome analysis;
27.2. Ensures personnel management processes, document and archive management;
27.3. Ensures management of property and estate;
27.4. Organises the introduction, maintenance and streamlining of a quality management system;
27.5. Organises rational and purposeful use, development of Agency’s information technology infrastructure, as well as ensures operation of Agency’s information system and data transmission network, and data protection within it.
28. The Legal Division ensures legal support for Agency’s structural units in the field of operation of the Agency, as well as conducts legal review of issues in the competence of the Agency and provides solutions, ensures planning of Agency’s procurements, preparation of procurement documentation and provides legal support in the field of public procurements.
29. The Financial Accounting, Analysis and Planning Division conducts financial analysis, budget planning and prepares the annual draft budget of the Agency, keeps Agency’s financial records, ensures 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.
30. The Public Relations Division ensures internal and external communication activities regarding functions and tasks in the competence of the Agency.
31. In accordance with common standards and procedures the structural units of the Agency cooperates with competent authorities for medicinal products and medical devices in European Union member states and European Economic Area countries, as well as participates in the work of European institutions and international organisations by participating in the performance of specific tasks.
V. Verification of Administrative Decisions
32. Preliminary basic verification of the expediency and legality of administrative decisions (administrative act, order, etc.) shall be conducted by the person preparing the draft decision and the relevant senior official upon issuing a visa (approval) for the draft, as well as the person adopting the decision upon signing the decision.
33. If necessary, additional verification of the legality of administrative decisions in the Agency shall be conducted by the Legal Division or an official appointed by the director of the Agency, evaluating its compliance with normative acts and general legal principles, as well as state administration principles.
34. Incidental (regarding the particular case), random and regular subsequent verification of administrative decisions shall be conducted by the monitoring auditor or Agency’s civil servant or employee appointed by the director.
VI. Closing Provisions
35. Repeal the Regulation of the Agency No.1-16/4 of 12 September 2022 “Regulation of the State Agency of Medicines”.
36. This Regulation shall come into force on 14 November 2023.
Approved by the Minister for Health on 14 November 2023, letter No. 01‑16.1/5125.
Director I. Dreika
