Impactful supervision

Two healthcare professionals working.
© GettyImages/sanjeri

Fimea's role in achieving the UN Sustainable Development Goal

Appropriately targeted, efficient and impactful supervision of pharmaceutical services and medical device operators is the basis for ensuring patient safety and human and animal well-being.

Actions to achieve the goal

Fimea issues, for example, licences for national pharmaceutical companies and pharmaceutical distributors and is responsible for regular inspections of operators. Fimea also inspects foreign operators. Fimea is part of a European regulatory network to prevent the distribution of counterfeit medicines and medicinal products. In case of incidents in pharmaceutical manufacturing or distribution, Fimea will act to minimise and manage patient safety risks to safeguard the interests of consumers.

Fimea issues licences for blood and tissue establishments and is responsible for regular inspections of the establishments and for handling incidents and adverse reaction reports concerning them.

Fimea supervises the regulatory compliance of medical devices and the operators in the sector. The supervision of the regulatory compliance of devices pertains to medical devices placed on the market as well as their professional use and maintenance. In addition, Fimea supervises the marketing of medical devices, handles incident reports and issues certificates of free sale, clinical trial permits and exemptions for medical devices.

In its national supervision, Fimea pays attention to the processing and disposal of pharmaceutical waste. Fimea has an environment team that supports the supervision and guidance of operators.

To ensure the sustainability and crisis resiliency of European supervision of medicines and devices, Fimea has promoted the development and introduction of remote supervision.