Skip to main content

Statute and Regulations

Statute

 

Unofficial translation

 

 

Cabinet of Ministers Regulation No. 537
Riga, 31st July 2012 (protocol No. 42, §50)

 

 The Statutes of the State Agency of Medicines

 

Issued in accordance with Section 4, Article 2
of the Law on Public Agencies

 

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;

 

4.6.      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;

 

4.8.      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

 

 


Original in Latvian

Regulations

REGULATION

 

Riga

 

 

24.07.2014 No. 1-10/7

 

Regulation of the State Agency of Medicines

(including amendment No. 1-10/1 of 4 January 2016;

amendment No. 1-10/1 of 5 January 2017)

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 and work management of the State Agency of Medicines (hereinafter – Agency).

II. Structure of the Agency

  1. The structure of the Agency is laid down by the order of the Director of the Agency.
  2. 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.
  3. The Deputy Director, Quality Manager and Monitoring Auditor are directly subordinate to the Director. (amendment No. 1-10/1 of 5 January 2017)
  4. The structural units of the Agency consist of departments, divisions and the laboratory:
    1. Directly subordinate to the Director:

5.1.1. Medicines Marketing Authorisation Department, including the following structural units:

5.1.1.1. Efficacy and Safety Division;

5.1.1.2. Pharmaceutical Information Division;

5.1.1.3. Procedure Coordination Division;

5.1.2. (revoked with amendment No. 1-10/1 of 4 January 2016);

5.1.3. Clinical Trials Department;

5.1.4. Financial Accounting, Analysis and Planning Department;

5.1.5. Administrative Resources and Documents Management Department;

5.1.6. Public Procurement and Infrastructure Provision Department;

5.1.7. Legal Department;

5.1.8. Information Technologies and System Development Department;

5.1.9. Public Relations Department (introduced with amendment No. 1‑10/1 of 5 January 2017).

 

    1. The following departments are directly subordinate to the Deputy Director of the Agency:
      1. Information on Medicines Distribution Department;
      2. Pharmaceutical Activities Company Licencing Department;
      3. Pharmaceutical Activities Compliance Evaluation Department;
      4. Medical Devices Evaluation Department;
      5. Medicines Examination Laboratory.
  1. The Agency has the following standing commissions:
    1. Commission on Marketing Authorisation of Human Medicines;
    2. Commission on Evaluation of Product Compliance with the Definition of Medicines;
    3. Commission on Licensing of Pharmaceutical Activity;
    4. Commission on Evaluation of Application of Annual Post-Marketing Maintenance Fee Waiver;
    5. Commission of Experts in Document and Archive Management;
    6. Procurement Commission;
    7. Ethics Commission;
    8. Commission on Registration and Evaluation of Gifts

(introduced with amendment No. 1-10/1 of 5 January 2017)

    1. Commission on Management of Information and Communications Technology Projects

(introduced with amendment No. 1-10/1 of 5 January 2017)

  1. The Agency has established a Pharmacovigilance Council.
  2. In order to ensure the tasks within the competence of the Agency, the Director may issue an order for the establishment of additional commissions and councils. The Director shall determine the functions, responsibilities and work management of commissions and councils in the regulations of commissions and councils, and shall appoint the chairpersons, deputy chairpersons, members of commissions and councils with an order of the Director.

III. Work Management of the Agency

  1. The work of the Agency shall be managed by the Director.
    1. The Director:
      1. Shall plan, manage and coordinate the work of the Agency and ensure its legality;
      2. Shall ensure the establishment of the midterm operational strategy, annual work plan and draft budget, as well as completion of the approved work tasks within the established budget;
      3. Shall ensure preparation of proposals and opinions regarding policy documents;
      4. Shall operate with the financial resources of the Agency and shall hold responsibility for their use;
      5. Shall represent the Agency without special authorisation;
      6. Shall appoint, hire and release from employment all Agency employees and civil servants;
      7. May give direct orders and assign tasks to any Agency employee or civil servant;
      8. Shall continuously adopt decisions regarding issues in the competence of the Agency, shall abolish or amend the orders issued or decisions adopted by the Deputy Director, Heads of structural units and other civil servants and employees of the Agency;
      9. Within his/her competence shall provide information 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.
  2. 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.
  3. 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.
  4. In the absence (temporary disability, vacation, business trip, etc.) of the Director of the Agency, an Agency official is appointed as the Acting Director by the order of the Ministry of Health in accordance with the proposal of the Director.
  5. The Deputy Director:
    1. According to his/her competence, shall plan, manage, organise and coordinate the work of the Agency structural units under his/her direct subordination, and shall assign tasks to the Heads, employees and civil servants of these structural units, as well as cooperate with other structural units of the Agency;
    2. Within his/her competence, shall ensure implementation of normative acts and orders of the Director of the Agency;
    3. According to his/her competence, shall represent the Agency in relations to other state administration institutions, professional associations of doctors and pharmacists, non-governmental organisations in the field, and natural persons;
    4. Shall submit proposals to the Director regarding management of Agency 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.
  6. (repealed with the amendment No. 1-10/1 of 5 January 2017);
  7. (repealed with the amendment No. 1-10/1 of 5 January 2017);
  8. The Quality Manager shall organise the implementation, maintenance of and improvements to the quality management system in the Agency in accordance with the requirements of normative acts and international quality standards.
  9. The Monitoring Auditor shall conduct audit of the Pharmacovigilance system, internal audit of the quality and information systems, shall inspect the operation of the internal control system of the Agency and shall provide his/her assessment and proposals for improvements to the internal control system to the Director of the Agency, as well as ensure monitoring of the implementation of the plan of organisational anti‑corruption measures in the Agency.
  10. The Heads of structural units of the Agency:
    1. Shall ensure implementation of normative acts and orders of the Director and Deputy Director according to the competence of the structural unit;
    2. Shall plan, manage, organise and coordinate the work of structural units, as well as supervise the completion of the tasks assigned to the structural unit;
    3. Shall evaluate the operational results of the structural unit and provide information to the Director or Deputy Director;
    4. According to the competence of the structural unit, shall prepare proposals for improvements to normative acts regulating the pharmaceutical field;
    5. Within the competence of the structural unit, shall ensure preparation of administrative acts, administrative decisions and internal normative acts;
    6. Shall ensure structural unit cooperation with other structural units of the Agency, state administration institutions, professional associations of doctors and pharmacists, natural persons and international institutions according to the competence of and tasks assigned to the structural unit;
    7. According to the competence of the structural unit, shall prepare proposals for the midterm strategy and work plan of the Agency, shall 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;
    8. According to the competence of the structural unit, shall ensure provision of opinion regarding documents, internal normative acts and draft administrative decisions prepared by other Agency structural units;
    9. Shall issue the regulation of the structural unit after receiving approval from the Director;
    10. Shall 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;
    11. Shall determine obligations and level of responsibility of structural unit employees and civil servants, and, after receiving approval from the Deputy Director of the Agency according to subordination, shall submit to the Director for approval the job descriptions of employees and civil servants.
  11. Specific tasks of Heads of structural units of the Agency for the implementation of Agency functions and tasks shall be laid down in the regulation of the structural unit and job description.
  12. Heads of structural units of the Agency may have Deputies, with competence of Deputy Heads laid down in regulations of structural units or job description.
  13. If an employee or civil servant has received a direct order from the Director or Deputy Director, the employee shall inform the Head of his/her structural unit.
  14. The authority of the Director, Deputy Director, Heads and Deputy Heads of structural units to sign documents for state administration institutions, municipal government institutions, other legal entities and natural persons, and foreign institutions are laid down according to the competence of the relevant position in the Agency order regarding delegation of signatory powers and other normative acts.
  15. Procedure for work management issues not reflected in this Regulation is laid down in the internal normative acts of the Agency.

IV. General Competence of the Structural Units of the Agency

  1. The Medicines Marketing Authorisation Department shall evaluate the compliance of medicines marketing authorisation documentation (including with regard to quality, efficacy and safety of medicines) with the requirements of normative acts and shall ensure marketing authorisation of medicines, conduct pharmacovigilance, create and regularly update the Medicinal Product Register of Latvia, as well as evaluate compliance of products with the definition of medicines upon request.
  2. (repealed with amendment No. 1-10/1 of 4 January 2016);
  3. The Medical Devices Evaluation Department shall evaluate the compliance of documentation of medical devices manufactured in Latvia and medical devices without CE marking with the requirements of normative acts, register these devices, ensure issuance of permits for release of specially supplied medical devices, evaluate compliance of clinical trial documentation for medical devices with the requirements of normative acts and ensure issuance of authorisation for conduct of clinical trials with medical devices, conduct vigilance for medical devices, as well as create and update the medical device register of Latvia.
  4. The Clinical Trials Department shall evaluate the compliance of clinical trial project documentation with the requirements of normative acts and ensure issuance of authorisations for initiation of clinical trials in Latvia, perform monitoring of clinical trials with medicines conducted in Latvia, evaluate their compliance with the requirements of good clinical practice, evaluate the applications for non‑interventional studies with medicines and ensure their registration in the Agency.
  5. The Pharmaceutical Activities Compliance Evaluation Department:
    1. Shall evaluate and inspect the compliance of medicines, active substance and excipient manufacturers and importers with the requirements of good manufacturing practice, and ensure issuance of good manufacturing practice certificates;
    2. Shall evaluate and inspect compliance of medicines wholesalers, active substance distributors and persons conducting intermediary transactions with medicines with the requirements of good distribution practice, and ensure issuance of good distribution practice certificates;
    3. Shall 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, 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.
  6. The Medicines Examination Laboratory shall ensure expertise on quality of medicinal product samples, selection and testing of purified water samples obtained in pharmacies.
  7. The Information on Medicines Distribution Department:
    1. Shall ensure issuance of permits for import, export, transit, distribution and purchase (to ensure own operation) of medicines, as well as for use of herbs, substances and medicines 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;
    2. Shall ensure issuance of precursor operator registration cards and special permits (licences) for operation with precursors;
    3. Shall ensure assembly, processing, analysis and distribution of statistics on medicinal product consumption and medicinal product availability data.

(as stipulated by amendment No. 1‑10/1 of 5 January 2017)

  1. The Pharmaceutical Activities Company Licencing Department:
    1. Shall review and verify compliance of pharmaceutical activity company documentation with the requirements of normative acts and ensure issuance of special permits (licences) for pharmaceutical activity;
    2. Shall ensure registration of active substance manufacturers, importers, distributors and persons conducting intermediary transactions with medicines, and issuance of registration certificates.
  2. Administrative Resources and Documents Management Department shall ensure the function of human resources management in the Agency, shall establish, organise and supervise the record-keeping process and the document management system in the institution, and manage the Agency archive.

(as stipulated by amendment No. 1‑10/1 of 5 January 2017)

  1. The Legal Department shall conduct legal review of issues in the competence of the Agency and provide solutions.
  2. The Financial Accounting, Analysis and Planning Department shall conduct financial analysis, plan the Agency budget and prepare the annual draft budget of the Agency, assemble the financial report of the Agency, ensure internal control of the accounting processes of the Agency with regard to utilisation of material, human and financial resources of the Agency and maintenance of the Agency property.
  3. The Public Procurement and Infrastructure Provision Department shall plan and organise public procurement in the Agency, ensure management of material valuables of the Agency, as well as organise work safety measures in the Agency.
  4. 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 information systems and data transmission network, and protection of the data therein.

36.1 The Public Relations Department shall ensure internal and external communication activities regarding functions and tasks in the competence of the Agency.(introduced with amendment No. 1‑10/1 of 5 January 2017)

  1. Complying with common standards and procedures the structural units of the Agency shall cooperate with medicines and medical devices agencies in the 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. Competence of the Commissions and Council of the Agency

  1. Commission on Marketing Authorisation of Human Medicines shall evaluate compliance of documentation submitted for medicines marketing authorisation, renewal and variations, based on normative acts, submitted documents and the opinion of the Medicines Marketing Authorisation Department, and shall provide recommendation to the Director of the Agency regarding marketing authorisation or renewal, refusal of marketing authorisation or renewal, suspension of marketing authorisation or renewal, renewal or annulment of marketing authorisation, approval or rejection of variations to marketing authorisation documentation.
  2. Commission on Evaluation of Product Compliance with the Definition of Medicines shall adopt a decision regarding product compliance with the definition of medicines based on normative acts, submitted documents and opinion of the Medicines Marketing Authorisation Department, and shall provide recommendation to the Director of the Agency regarding product compliance or non-compliance with the definition of medicines laid down in the Pharmaceutical Law.
  3. The Commission on Licensing of Pharmaceutical Activity shall evaluate the submitted documents and information related to the licencing process of pharmaceutical activity companies, based on normative acts, documents submitted by merchant or person registered as a performer of economic activity at the State Revenue Service, report from the Pharmaceutical Activities Compliance Evaluation Department of the Agency and the opinion of the Pharmaceutical Activities Company Licencing Department, and shall provide recommendation to the Director of the Agency regarding issuance or renewal of special permit (licence) to pharmaceutical activity company, suspension of special permit (licence) or lifting of suspension, annulment of special permit (licence) or refusal to issue or renew special permit (licence).
  4. The Commission on Evaluation of Application of Annual Post‑Marketing Maintenance Fee Waiver shall evaluate applications regarding waiving of the annual post-marketing maintenance fee submitted by a marketing authorisation holder or its authorised representative, and based on normative acts and submitted documents shall provide recommendation to the Director of the Agency to waive or not waive the annual post-marketing maintenance fee.
  5. The Commission of Experts on Document and Archive Management shall organise annual selection of documents for continuous storage and selection of personnel documents for further storage, as well as selection of temporarily (for up to 10 years) stored documents to be destroyed.
  6. The Procurement Commission shall ensure preparation of procurement procedure documentation, protocolling of the procurement process, provision of answers regarding progress of the procurement procedure, evaluate the offers submitted by candidates in accordance with the Law on Public Procurements, the procurement procedure documents, as well as other normative acts, and shall adopt a decision regarding announcement of the winner of the procurement procedure or termination of the procurement procedure.
  7. The Ethics Commission shall evaluate and review the complaints submitted regarding the conduct of Agency employees or civil servants by submitting an opinion to Agency administration regarding the fact of violation of a specific standard of conduct of the Code of Ethics of the Agency or assessment of the situation in cases where the fact of misconduct has not been established.

44.1 The Commission on Registration and Evaluation of Gifts shall ensure registration and review of the reports submitted by Agency officials regarding acceptance of gifts, as well as keep record of gifts and adopt a decision regarding further action with regard to gifts.

(introduced with amendment No. 1-10/1 of 5 January 2017)

44.2 The Commission on Management of Information and Communications Technology Projects shall promote efficient management of information and communications technologies at the Agency and ensure uniform development of information technology to ensure completion of the functions and tasks assigned to the Agency.

(introduced with amendment No. 1-10/1 of 5 January 2017)

  1. The Pharmacovigilance Council shall analyse and scientifically evaluate the safety monitoring data and information regarding medicines included in the Medicinal Product Register of Latvia, as well as medicines distributed in Latvia, and shall provide recommendation to the Director of the Agency regarding further measures and actions required to prevent or minimise medicinal product risks.

VI. Verification of Administrative Decisions

  1. Preliminary basic verification of the expediency and legality of administrative decisions (administrative act, order, etc.) shall be conducted by the person preparing the draft and the appropriate superior official by issuing a visa (approval) for the draft, as well as the person adopting the decision by signing the decision.
  2. Additional verification of the legality of administrative decisions in the Agency shall be conducted by the Legal Department.
  3. Separate, random and regular subsequent verification of administrative decisions in the Agency shall be conducted by the Monitoring Auditor or an Agency civil servant or employee appointed by the Director of the Agency.

VII. Closing Provisions

  1. This Regulation shall come into force on 24 July 2014.

Approved by the Minster for Health on 16 July 2014 (Letter No. 01‑16.1.15/2488 from the Ministry of Health “Regarding Draft of Internal Normative Act “Regulation of the State Agency of Medicines””)

 

Director

  1. Adovica

Amendment No. 1-10/1 of 4 July 2016 approved by the Ministry of Health with the 04.01.2016 letter No. 01-16/7 “Regarding Draft of Internal Normative Act “Amendments to the Internal Normative Act of the State Agency of Medicines No. 1-10/7 ”Regulation of the State Agency of Medicines””.

Amendment No. 1-10/1 of 5 January 2017 approved by the Ministry of Health with the 04.01.2017. letter No. 01-16.1/59 “Regarding Amendments to the Regulation of the State Agency of Medicines”.