Fimea and wellbeing services counties

Fimea ensures the general availability of medicines together with other operators. Finland’s operations related to mandatory reserve medical supplies contribute to safeguarding the availability of and access to critical medicines in circumstances in which usual availability in Finland is restricted or suspended as a result of supply disruptions, a serious crisis or other equivalent reason. 

The Act on Mandatory Reserve Supplies (979/2008) applies to pharmaceutical plants, importers of medicinal products, health care units and the Finnish Institute for Health and Welfare. 

Fimea prepares a list of medicines to be stocked as mandatory reserve supplies, monitors the implementation of stocking of mandatory reserve supplies and, if necessary, grants operators exemptions to maintain lower stock levels.

Mandatory reserve supplies in health care units

Operating in the event of a shortage

When a shortage compromises the pharmacotherapy of any specific patient group, Fimea investigates ways to resolve the shortage in cooperation with pharmaceutical companies. For example, Fimea may grant exemptions for the market entry of different language versions of packages or time-limited approvals for substitute medicinal products. 

The information displayed in Fimea’s shortage search is based on pharmaceutical companies’ reports on shortages of certain medicinal products and their estimated durations. As marketing authorisation holders, pharmaceutical companies are responsible for releasing medicinal product onto the market and discontinuing their marketing.

Shortage search

Background information on the availability of medicines in Finland

Therapeutic and economic value assessments of medicines and support for centralised procurement

Fimea mainly assesses new hospital-only medicines when they first enter the market. Based on the evaluations, the Council for Choices in Health Care in Finland will issue a recommendation on the inclusion of the medicines in the range of services financed from public funds. After the recommendation procedure, medicines typically fall under centralised national procurement. 

Assessment of pharmacotherapies (HTA)

Assessment reports (in Finnish)

Assessment of hospital-only medicinal products

We are responsible for supervising pharmaceutical industry operators, such as hospital pharmacies, dispensaries and community pharmacies. Our  supervision tasks also included medical devices, blood and tissue establishments and biobanks. We provide support to the wellbeing services counties with questions concerning the organisation and self-monitoring of these services and with compliance with the legislative framework.

Pharmaceutical services and dispensing of medicines

Fimea grants licences to pharmacies, hospital pharmacies and dispensaries, and supervises the legality of their operations, the safety of pharmaceutical manufacturing and the marketing of medicines. Pharmacies

Use of medical devices

The supervision of the regulatory compliance of devices pertains to medical devices placed on the market as well as their professional use and maintenance. The supervision is carried out in collaboration with other EU authorities.

In addition, Fimea supervises the marketing of medical devices, handles adverse incident reports, issues certificates of free sale, and grants clinical trial permits and exemptions for medical devices.

Medical devices

Use of blood and tissue products, organ transplants and gene technology

Fimea supervises blood and tissue establishments, organ donation transplantation activities and the quality and safety of organ transplants. Fimea also supervises Finnish biobanks and inspects some areas utilizing gene technology. The handling and use of these products in health care requires specific permits from Fimea.

Tissue permits (in Finnish and in Swedish)

Supervising tissue establishment

Supervision of organ activity

Safety of blood products and operations of blood centres

ATMP supervision (in Finnish)

Biobanks

Fimea supports the guidance of pharmaceutical services and the use of medicines in the wellbeing services counties with various data products. We also supervise and provide advice on compliance with the legislation related to our tasks. Some laws related to our area are available on the National laws page. 

National laws

Fimea's administrative regulations
Fimea’s normative guidelines

To support knowledge-based management in the wellbeing services counties, we publish various data products, including statistics, indicators, studies and reports. 

We produce data on pharmacy operations and pharmacy economy, for example on the use of pharmacy services and medicines as well as their availability and accessibility, drug advice, the substitution of medicines and pharmacy economy to support decision-making. Apteekkitoiminta (in Finnish and in Swedish) 

Indicators describing safe drug therapy for older adults are published as part of the KuVa indicators in the set of indicators measuring the cost-effectiveness of social welfare and health care (5035, 5036).
Sotekuva (in Finnish) 

Finnish statistics on medicines

Reports to support the development of pharmaceutical services (in Finnish and in Swedish)

Tool for monitoring the cost development of medicines, Fimea & Kela 
Data on the cost development of medicines and regional reference data for monitoring the implementation of rational pharmacotherapy. Tool (in Finnish) 

To support social welfare and health care professionals and organisations, we publish various guides, databases and information packages.  

Safe pharmacotherapy guide and template for a pharmacotherapy plan, (in Finnish and in Swedish)

Meds75+ database,

Medicines Barometer (in Finnish) 

National Risk Medicines Classification (coming in 2023)

Information packages for pharmacotherapy (in Finnish and in Swedish)

Our medicines guidance provides scientific advice to regional research groups on issues to be considered in medicines development and information on regulatory requirements already at an early stage before authorisation procedures become topical. The purpose of these operations is to promote and streamline the development of pharmaceutical innovations, but we will not take a regulatory stand on the prodrug before the actual authorisation procedures begin. Our medicines guidance also supports and provides information on similar services provided by the European Medicines Agency (i.e., the SME office) and on the opportunities offered by EU projects (e.g., STARS, decentralised trials guidance).

Training offers administrative advice and support for the implementation of clinical trials. The clinical trials division organises training on authorisation and transaction procedures related to clinical trials and also information on any relevant training organised by the European Medicines Agency.

Medicines development support

Supervision of clinical trials