Organisation

We process matters related to marketing authorisations and the registration of human and veterinary medicines and provide related scientific advice. This includes licence and permit matters referred to in the Medicines Act, certificates of a pharmaceutical product for export purposes, and exemptions from processing and licence fees.

We draw up the list of interchangeable medicinal products that is referred to in the Medicines Act and the list referred to in the Act on Obligatory Storing of Medicines and assess the need to review the list. We are responsible for pharmacopoeia activities and other standardisation related to the pharmaceuticals sector.

We often carry out work on marketing authorisations in cooperation with the other national medicines agencies in Europe. We are part of the EU’s marketing authorisation network.

We provide scientific and regulatory guidance supporting drug development in the network of the medicines agencies in Europe, nationally and internally within Fimea.

We accept and assess the adverse reaction reports submitted on medicines and look for previously unknown adverse reactions based on the reports. We assess periodic safety update reports and risk management plans.

We assess and monitor clinical drug trials. We process permit and other matters related to clinical drug trials and are responsible for inspections of clinical drug trials and pharmacovigilance inspections.

We assess the therapeutical and economic value of the medicines used in hospitals, and produce and compile data on pharmacotherapies for these assessments. We coordinate the cooperation concerning the assessments.

We supervise the marketing of medicines and decide on the classification of products as medicines (vs. dietary supplement, chemical, novel food, etc.).

We are responsible for the supervision of pharmaceutical industry operators, including procedures related to licence, permit and registration matters, inspections of operation and the reporting of the inspections. The operators include pharmacies, hospital pharmacies and pharmaceutical centres, among others.

We supervise the operation of blood and tissue establishments, the quality and safety of human organs used in organ transplantations and the operation of biobanks and embryo research institutions. We also process the notification, permit and inspection matters related to them.

We manage the availability of medicines and supervise the quality of medicines and other products on the market. We are responsible for monitoring and reporting on the availability of medicines and veterinary medicines and for receiving and processing shortage notifications of medicines.

We are responsible for the market surveillance of medical devices and for the designation and supervision of notified bodies for medical devices. We process the guidance, notification, exemption and classification matters concerning medical devices. In addition, we process the notification, permit and inspection matters related to clinical device trials and performance studies of IVD devices.

We develop the management of Fimea and its human resources and take care of Fimea's strategic development.

We take care of HR management, the pay system and activities related to collective bargaining at Fimea and manage Fimea’s agency and support services.

We are responsible for the development of the work environment, the coordination of safety and risk management, and the management and support of procurement.

We manage financial planning, the budget, the distribution of operating appropriations, the agency’s accounting and its duties as an accounting unit, and the agency’s payment matters.

We manage Fimea’s legal matters, provide legal advice and represent Fimea in courts.

We maintain, plan and develop information management, document management and archive operations at Fimea.

We prepare and coordinate sustainability reporting and maintain and develop the quality system applying to the entire agency.

We maintain, plan and develop information management at Fimea.

We maintain and develop Fimea’s information systems, IT infrastructure, enterprise architecture and information security in cooperation with the areas of responsibility and the service providers.

We take care of the maintenance of the agency’s information management system and the creation and storage of the data. We participate in the development of information management nationally and at the level of the EU.

We conduct scientific research in the research areas of pharmacoepidemiology, pharmaceutical policy and pharmacoeconomy. In the project office, we are responsible for the management of Fimea’s projects as a whole.

We work in cooperation and develop network-based activities with the authorities, universities and research institutes, healthcare and social welfare units, and other actors in the sector.

We plan, coordinate, develop and implement Fimea’s internal and external communications in cooperation with the director general, the management group and the areas of responsibility. We support the areas of responsibility, units, divisions and experts with communications.

We are responsible for developing and coordinating online communications as well as for publishing and its development. We manage media relations and other stakeholder communications and maintain Fimea’s social media channels.

We are actively involved in reform projects, other projects and communication campaigns. We measure the outcomes of communications.