Published: 2014-09-13
Key Benefits:
Passed 11.10.2005 Annex 105
RTL 2005, 105, 1606
Entry into force 21.10.2005
| 30.12.2008 | RTL 2009, 1, 9 | 10.01.2009, to be applied as of 01.01.2009 |
| 25.11.2009 | RTL 2009, 89, 1307 | 01.01.2010 |
| 08.11.2011 | RT I, 11.11.2011, 4 | 01.01.2012 |
| 06.05.2013 | RT I, 10.05.2013, 1 | 13.05.2013 |
| 05.09.2014 | RT I, 10.09.2014, 1 | 13.09.2014 |
This regulation is enacted under ss. 42(1) and 49(1)(10) of the Government of the Republic Act and in accordance with the Medicinal Products Act, the Act on Narcotic Drugs and Psychotropic Substances and Precursors thereof, and the Handling and Transplantation of Cells, Tissues and Organs Act.
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
(1) The State Agency of Medicines (hereinafter, ‘the Agency’) is an executive agency of the government that operates in the area of government of the Ministry of Social Affairs, fulfils a directing function, performs a public supervision function and exercises enforcement powers of the state on the grounds and to the extent provided by law.
(2) In the performance of its functions, the Agency represents the government.
(3) The Agency is an institution funded from the national budget and from the revenue raised though its economic activities. The Agency’s budget is approved and amended and its implementation is scrutinised by the minister responsible for the area in accordance with the procedure established by law. The Agency holds bank accounts under the group account of the State Treasury.
[RT 10.09.2014, 1 – entry into force 13.09.2014]
(4) The name of the Agency in English is ‘State Agency of Medicines’.
(1) The Agency is situated in Tartu. The Agency’s postal address is 1, Nooruse St, Tartu 50411. The postal address of the Agency’s unit in Tallinn is 102, Pärnu Rd, Tallinn 11312.
The purpose of the Agency’s activities is to ensure that the medicinal products that are authorised in Estonia for use in the prevention, treatment and diagnosis of human and animal diseases are evidenced to be effective and are safe and of high quality, to facilitate the use of medicinal products according to their intended purpose and to ensure the safety and protection of rights of participants of any clinical trials of medicinal products that are conducted in Estonia.
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
The Agency:
1) grants marketing authorisations for medicinal products (including veterinary medicinal products);
2) conducts expert assessment of applications for marketing authorisations and verifies the chemical and pharmaceutical properties of medicinal products;
3) grants import and export authorisations, including authorisations to the handlers of precursors;
4) verifies the quality of medicinal products and the quality of the starting materials used for the preparation of medicinal products;
5) prohibits the use of dangerous medicinal products or starting materials for medicinal products, or medicinal products or starting materials that do not meet quality requirements or establishes restrictions on their use;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
6) scrutinises compliance with the legislation concerning medicinal products and narcotic drugs and psychotropic substances;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
7) classifies proprietary medicinal products;
8) conducts expert assessment of applications for clinical trials of medicinal products, grants or refuses authorisations for clinical trials and scrutinises the conduct of clinical trials;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
9) classifies products as medicinal products and classifies substances or medicinal products as narcotic drugs or psychotropic substances;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
10) arranges notification of adverse reactions to medicinal products and the corresponding reporting;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
11) participates in the preparation of legislation concerning medicinal products and narcotic drugs, psychotropic substances and precursors, and in the preparation of explanatory memoranda for such legislation;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
12) for the purpose of implementation of legislation, prepares instructions for the manufacturing, marketing, storage and use of medicinal products;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
13) in accordance with legislation, disseminates information related to medicinal products;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
14) establishes arrangements concerning reporting on the marketing of medicinal products, scrutinises the accuracy and objectivity of such reports and systematises and analyses them;
15) inspects the handling of narcotic drugs and psychotropic substances for medical and scientific purposes and grants relevant authorisations;
16) exercises supervision concerning narcotic drugs and psychotropic substances and their precursors and prepares reports in accordance with international conventions ratified by Estonia;
17) exercises supervision concerning compliance with the requirements for the advertising of medicinal products subject to medical prescription and medicinal products not subject to medical prescription;
18) inspects businesses that manufacture, store, market, use or research medicinal products;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
19) issues opinions concerning applications for the inclusion of medicinal products in the list of medicinal products to be dispensed from pharmacies at discounted prices;
20) processes applications for authorisation (including applications for authorisation for the handling of medicinal products, for the handling of precursors and for the handling of cells, tissues and organs);
[RTL 2009, 1, 9 – entry into force 10.01.2010 – to be applied as of 1.01.2009]
21) processes applications for the use of unauthorised medicinal products;
22) [Repealed – RTL 2009, 89, 1307 – entry into force 01.01.2010]
221) exercises supervision concerning compliance with the requirements for handling (except for removal) of cells, tissues and organs;
[RTL 2009, 1, 9 – entry into force 10.01.2010 – to be applied as of 1.01.2009]
23) represents Estonia in the committees of the European Medicines Agency and other EU or international bodies dealing with medicinal products, narcotic drugs and psychotropic substances and their precursors;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
231) carries out the communication and cooperation described in Directive 2001/83/EC (on the Community code relating to medicinal products for human use) with the European Commission, Council of Europe, European Medicines Agency and other competent authorities of the member states;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
232) manages and implements the pharmacovigilance systems referred to in Directive 2001/83/EC (on the Community code relating to medicinal products for human use);
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
233) arranges the dissemination of information in order to ensure the safe and correct use of medicinal products and the avoidance of counterfeit medicinal products;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
24) performs other functions that arise from Acts of the Riigikogu and other legislation or that are entrusted to the Agency by the minister responsible for the area.
[RT I, 10.09.2014, 1 – entry into force 13.09.2014]
In order to perform its functions, the Agency is authorised, within the limits of its competence:
1) to request information from persons handling medicinal products (including narcotic drugs and psychotropic substances) regarding their professional activities and to inspect the preparation, storage, marketing and dispatch in any other manner of all medicinal products and other products that have a medical purpose (except for medical devices) and to scrutinise the relevant documentation;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
2) where infringements are discovered, to issue enforcement orders to discontinue the infringement;
3) obtain from other authorities and legal and natural persons that handle medicinal products, narcotic drugs and psychotropic substances the information necessary for performing the functions described in these Statutes;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
4) to convene, reorganise and dissolve committees within its area of activity;
5) to contract consultants and experts and involve them in its work:
6) within the limits of its competence, to negotiate and to enter into agreements with legal and natural persons active in Estonia and in foreign countries;
7) to remove medicinal products in the possession of legal and natural persons for the purpose of verifying their quality and compliance with the requirements;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
8) to issue enforcement orders to discontinue the marketing of dangerous and low-quality medicinal products and to remove such products from the market and to verify compliance with such orders;
9) to temporarily suspend the activities of a business or part of thereof if such activities endanger human health or human environment;
10) to suspend or revoke activity licences in the event of a violation of the requirements established in the Medicinal Products Act and in the legislation enacted under it;
11) to impose sanctions on natural or legal persons in the event of a violation of the requirements established in the legislation or to initiate the procedure for the imposition of sanctions;
12) to provide services on a paying basis to natural and legal persons in the cases and following the procedure established in legislation;
13) to publish printed matter (including periodical publications) related to medicinal products and to use other media to disseminate information concerning its area of activity;
14) where necessary, to use international experts in order to achieve the aims of its work or to use the services of a laboratory of the competent authority of a foreign country;
15) to participate in the activities of international organisations following the established procedure.
The Agency is headed by the Director General who is appointed to the office and released from the office by the minister responsible for the area at the proposal of the Secretary General. During the absence of the Director General, the Director General’s duties are performed by the Deputy Director General or an official appointed by the Director General.
[RT I, 10.09.2014, 1 – entry into force 13.09.2014]
The Director General:
1) presides over the work of the Agency, is responsible for accurate and expedient implementation of the legislation governing its activities and reports to the minister responsible for the area;
[RT I, 10.09.2014, 1 – entry into force 13.09.2014]
2) establishes the roster of service positions of the Agency such that the number of service positions does not exceed the number approved by directive of the minister responsible for the area, appoints to office and releases from office officials of the Agency following the established procedure and concludes employment contracts with the Agency’s employees and modifies and terminates such contracts;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
3) submits to the minister responsible for the area the Agency’s annual budget of receipts and expenditures and is responsible for accurate and expedient implementation of the budget;
4) [Repealed – RT I, 11.11.2011, 4 – entry into force 01.01.2012]
5) approves the job descriptions for positions on the basis of proposals of the heads of units;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
51) sets the salaries of the officials, decides the payment of other types of pay specified in legislation and decides the imposition of disciplinary penalties in the case of a breach of duties;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
52) agrees the rate of remuneration and where necessary other types of pay with the employees and and issues warnings to employees and invokes legal remedies provided in legislation in the case of a breach of duties;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
6) possesses, uses and disposes of the state assets and funds entrusted into the possession of the Agency in conformity with the State Assets Act;
7) convenes, reorganises and dissolves committees within the area of activity of the State Agency of Medicines;
8) establishes the procedure for the use of the Agency’s public seal;
9) submits, via the Deputy Secretary General for Healthcare, to the minister responsible for the area proposals to organise the Agency’s area of activity and prepares the draft annual budget of receipts and expenditures;
10) submits to the minister responsible for the area proposals to amend legislation concerning medicinal products;
[RTL 2009, 89, 1307 – entry into force 01.01.2010]
11) in accordance with an Act of the Riigikogu, a regulation or order of the Government of the Republic, or a regulation or order of the minister responsible for the area, makes administrative decrees relating to issues concerning the Agency’s service;
12) exercises service supervision to the extent and following the procedure established in Acts of the Riigikogu and other legislation;
13) in order to perform the functions of the Agency and to arrange the Agency’s work, approves the statutes of the Agency’s units and other rules, guidelines, procedures, memoranda and work arrangements;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
14) approves the documents relating to the quality management system of the Agency;
15) ensures the implementation of the Agency’s internal audit system and the performance of internal audits;
16) via the Deputy Secretary General for Healthcare, cooperates with the Ministry of Social Affairs to the extent of the functions described in the Agency’s Statutes;
17) in consultation with the mfinister responsible for the area, establishes the price list for the Agency’s services;
18) coordinates, directs and scrutinises the work of the Agency’s Administrative Department;
[RT I, 11.11.2011, 4 – entry into force 01.01.2012]
19) performs other functions vested in him or her by Acts of the Riigikogu and other legislation.
[RT I, 11.11.2011, 4 – entry into force 01.01.2012]
The Deputy Director General:
1) coordinates, directs and scrutinises the work of the departments engaged in carrying out the Agency’s main activities;
[RT I, 11.11.2011, 4 – entry into force 01.01.2012]
2) issues orders to heads of departments within the limits of his or her competence;
3) requests reports from heads of departments on their activities and scrutinises the performance of the duties of the officials and employees subordinate to him or her;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
4) makes proposals to the Director General for improving the clerical business and work arrangements in departments;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
41) makes proposals to the Director General for setting the salary of the officials and other types of pay provided in legislation and for the imposition of disciplinary penalties;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
42) makes proposals to the Director General for agreeing with the employees on the payment of remuneration and other types of pay and for issuing cautions and for application of legal remedies provided in legislation in the case of a breach of duties;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
5) makes proposals to the Director General with regard to the preparation of the annual budget and the use of budget funds;
6) within the limits of his or her competence, signs the Agency’s documents;
7) when needed, acts for the Director General;
8) represents the Agency within the limits of his or her competence and within the limits of the authority granted by the Director General;
9) is responsible for the implementation in the Agency’s practical work of the quality management system established in the Agency;
[RT I, 11.11.2011, 4 – entry into force 01.01.2012]
10) performs other duties assigned to him or her by the Director General.
The head of a department:
1) directly supervises the work of the department and arranges the performance of the functions within the competence of the department;
2) performs the duties of the Deputy Director General when appointed to do so by the Director General or the Deputy Director General;
3) participates in the preparation of the quality system, development plans, action plans and the Agency’s budget;
4) issues orders to subordinates for the performance of the functions of the department and oversees the performance of the orders;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
5) carries out the orders issued to him or her by the Director General or Deputy Director General or reports on any obstructions that prevent him or her from carrying out such orders;
6) exercises supervision over the officials and employees of the department;
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
7) arranges the performance of other functions assigned to the department.
During the absence of the head of department, the duties of the head are performed by the official or employee appointed by the Director General.
[RT I, 10.05.2013, 1 – entry into force 13.05.2013]
A bureau that forms a unit within a department is managed by the head of the bureau whose rights and duties are set out in the job description.
[Repealed – RT I, 11.11.2011, 4 – entry into force 01.01.2012]
[RT I, 11.11.2011, 4 – entry into force 01.01.2012]
The departments of the Agency and their main functions are as follows:
1) the Administrative Department, which arranges the planning of the budget, accounting, reporting on the implementation and analysis of the budget, administers the state assets entrusted into the possession of the Agency, keeps accounts on the state assets, arranges the maintenance of the state assets; arranges personnel work in the Agency, ensures the provision of IT services to the Agency, arranges the provision of secretarial services and provides support services to ensure the performance of the Agency’s functions;
2) the Department of Marketing Authorisations, which arranges and coordinates the assessment of the documentation concerning marketing authorisations, arranges and coordinates the assessment of modifications in the conditions which constitute the basis for the grant of the marketing authorisation; keeps the register of medicinal products, defines medicinal products and assesses the applications for clinical trials of medicinal products and exercises supervision over such trials;
3) the Department of Post-Authorisation Safety, which arranges the assessment of the pharmacovigilance system and risk management plans with respect to medicinal products, arranges the gathering, assessment and communication of information concerning post-authorisation safety of medicinal products, arranges the preparation of expert assessments when preparing the list of medicinal products that are dispensed from pharmacies at a discount, exercises supervision over compliance with the requirements for the advertising of medicinal products to the general public and to persons qualified to prescribe medicinal products as well as to pharmacists and assistant pharmacists, gathers and systematises data on the use of medicinal products in Estonia, maintains the coding centre;
4) the Department of Inspection, which to the extent provided in legislation exercises supervision over the handling, including imports and exports, of medicinal products, narcotic drugs and psychotropic substances and their precursors, processes applications for activity licences for the handling of medicinal products and their precursors and for modifications in such activity licences, arranges the information exchange relating to defective medicinal products, reports on violations of legal rules and on the decisions made in matters concerning activity licences;
5) the Quality Control Laboratory, which inspects the quality of medicinal products (including herbal substances) and of the starting materials used for the manufacture of medicinal products as well as the quality of medicinal plants (herbal substances) and their mixtures, establishes within the limits of its competence the rules for laboratory testing of the quality of medicinal products, participates in the work of the cooperation network of the European Pharmacopoeia and of the European national medicinal products’ quality control laboratories and provides consultation services to other departments in the area of its specialism;
6) the Department of Biologicals, which deals with blood and blood preparations, cells, tissues and organs of human origin as well as with novel medicinal products and other preparations containing materials of human or animal origin used for medical purposes, arranges supervision over the manufacture, marketing, export and import of such preparations and investigates dangerous incidents related to such preparations.
[RT I, 11.11.2011, 4 – entry into force 01.01.2012]
The Agency’s adviser is directly subordinate to the Director General or Deputy Director General and is not a member of the staff of any of the Agency’s units.
The adviser’s competence is defined in the adviser’s job description that is approved by a directive of the Director General.
(1) The Director General may convene permanent and temporary committees that have advisory power in the Agency’s area of activity.
(2) The committees are entitled to request information and documents that are necessary to carry out their work from the Agency’s units.
(1) Committees are convened by a directive of the Director General that defines the committee’s tasks and sets the time-limits for the completion of those tasks and appoints the chair and members of the committee.
(2) Public servants from other executive agencies of the government may be appointed as members of committees with the permission of the head of the relevant agency. Persons who are not public servants may be involved in committee work at their consent.
The Agency has a circle-shaped seal that has a diameter of 35mm and that bears the image of the lesser national coat of arms in the centre of the circle and the word ‘RAVIMIAMET’ on the rim of the circle.
(1) In using its insignia, the Agency follows the legislation governing the use of the national flag and the national coat of arms.
(2) The Agency’s administrative documents are formalised in accordance with the procedure established in legislation.
(3) The Agency has document forms for general purposes, for letters and for authorisations. The use of these forms is governed by the Agency’s clerical business rules.
(4) The Agency uses the Agency’s logo that has been registered following the procedure established in legislation.
The correspondence of the use of the funds allocated to the Agency from the national budget to the intended purpose of such funds and the conformity of the Agency’s activities to the aims arising from these statutes are scrutinised following the procedure established in legislation.
The activities of the Agency are reorganised or wound up following the procedure established in legislation.
[Omitted from this version.]
