Other permits

Other permits

In addition to marketing authorisation, Fimea provides many other permits and certificates relating to medicinal products.

Exemptions

A product with marketing authorisation can be granted an exemption if the product is critical for pharmaceutical services in Finland and its availability would be interrupted otherwise.

Read more: Exemptions

Special permissions for compassionate use

Special permissions can be granted for special medicinal reasons to products that do not have marketing authorisation in Finland.

Read more: Special permissions

Batch-specific control

Fimea grants batch-specific permits for releasing plasma-based medicinal products, immunoserums and vaccines used for immunoprophylaxis on the market.

Read more: Batch-specific control

Certificate of a pharmaceutical product (CPP)

Fimea provides pharmaceutical plants with certificates of a pharmaceutical product (CPP) for export purposes.

Read more: Certificates of a pharmaceutical product

Dose-dispensing

By application from the marketing authorisation holder, Fimea may grant a permit for a package size intended for dose-dispensing for a product with marketing authorisation.

Read more: Dose-dispensing

Authorisation of clinical drug trials

Fimea also processes authorisation applications for clinical drug trials.

Read more: Clinical drug trials