About The State Agency of Medicines

• Help people understand issues related to medicines and medical devices.

• Monitor the efficacy, quality, and safety of medicines and grants marketing authorisations.

• Ensure that medical devices used by people are effective and safe.

• Assess the eligibility of clinical trials for medicines and investigations involving medical devices.

• Issue licences for the handling of medicines and ensures compliance with relevant requirements.

• Evaluate the efficacy, quality, and safety of medicines both at the time of marketing authorisation and during their presence on the market.

• Collect and analyses data on incidents involving medical devices.

• Collect and analyse data on the use of medicines and adverse drug reactions, and assesses the relationship between vaccines and side effects in the context of vaccine injury compensation.

• Monitor the movement of medicines, narcotic and psychotropic substances, and their precursors across the Estonian border.

• Oversee the procurement and handling of blood, cells, tissues, and organs.

• Ensure compliance with advertising regulations for medicines and medical devices and supervises the functioning of pharmacovigilance systems maintained by marketing authorisation holders.

• Represent Estonia in the committees of the European Medicines Agency, the European Pharmacopoeia, and other bodies, as well as in the working groups of the European regulatory network for medicines and medical devices.

Mission of the State Agency of Medicines

The mission of the State Agency of Medicines is to protect human and animal health by promoting the proper use of medicines and medical devices and supporting the development of the sector.

Vision of the State Agency of Medicines

The Medicines Agency brings together leading, internationally recognised experts whose expertise, competence, and values ensure the continued development of the medicines and medical devices sector and foster responsible and informed use of medicines.

Values of the State Agency of Medicines

Competence

• We base our work on relevant scientific data and legislation and use the best expertise available in Estonia.
• We constantly update our knowledge and operating methods.
• We are aware that our every action reflects on the State Agency of Medicines and remember that our decisions have a significant impact.

Reliability

• We consider all known aspects when making decisions and we are impartial towards our partners and colleagues.
• We look for substantive solutions and keep our promises.
• We analyze our decisions, admit our mistakes and learn from them.

Efficiency

• We actively identify the areas in which we can be of assistance.
• We have a say in important discussions and initiate necessary changes.
• We value our own, our colleagues’ and our partners’ time.
• We complete what we start.

Cooperation

• We guide ourselves by the main purpose of the State Agency of Medicines to protect public health while contributing to the development of research and entrepreneurship in Estonia with our knowledge.
• We recognise opportunities for cooperation and are open to relevant suggestions.
• We value the expectations of our cooperation partners and adhere to agreements.

Development and Administration Department

The Development and Administration Department manages the planning, implementation, and deployment of the agency’s IT development projects, including information systems; data management; development and testing of new IT solutions; human resources and document management. The department maintains the agency’s archive, manages state property under the agency's control and organizes its maintenance; coordinates public procurement procedures; ensures secretarial services for the agency, and carries out other support functions necessary for fulfilling the agency’s duties.

Supervision Department

The Supervision Department oversees the activities of medicine handlers and handlers of narcotic drug precursors, including the issuance of operating licenses. It is also responsible for the supervision of cross-border movement of medicines. The department handles product classification and the issuance of permits related to personal use (e.g., traveling with medicines and postal shipments). In addition, it deals with notifications regarding medicine supply disruptions and oversees the conduct of clinical trials.

Medical Devices Department

The Medical Devices Department maintains the national registry of medical devices, collects and analyzes data on adverse incidents related to medical devices, resolves classification issues, and evaluates technical documentation of devices. The department also assesses applications for clinical investigations and derogations related to medical devices and supervises businesses operating in the medical devices sector.

Legal Department

The Legal Department ensures the legality of the agency’s services in the interpretation and application of legislation and in supervisory activities. It represents the agency in legal proceedings and other legal matters or discussions. The department participates in the legislative process concerning pharmaceutical law and represents the agency in international cooperation according to its area of competence.

Marketing Authorisations Department

The Marketing Authorisations Department conducts scientific assessments of marketing authorisation and clinical trial applications. Following a positive assessment, a marketing authorisation or a clinical trial authorisation is granted in Estonia. The department also supervises the conduct of clinical trials.

Biological Preparations Department

The Biological Preparations Department oversees the production of blood components and the procurement and handling of human-derived cells, tissues, and organs, including safety monitoring. The department is also responsible for matters related to advanced therapy medicinal products.

Laboratory

The agency’s laboratory controls the quality of medicines and substances used in the manufacture of medicines and participates in the work of the European Pharmacopoeia and the official medicines control laboratories network of the Council of Europe.

Pharmacovigilance Department

The Pharmacovigilance Department monitors the safety of medicines and investigates their use.