Pharmaceutical industry

 

Licences, compulsory stockpiling, monitoring and inspections

The monitoring of the pharmaceutical industry consists of licensing procedures, regular inspections and quality tests of medicinal products placed on the market. Normative regulation and guidance provision are natural parts of this government monitoring.

In Finland medicinal product manufacturer's licences and medicinal product wholesale dealer's licences are issued by Fimea. Under the Medicines Act, medicinal products may only be manufactured industrially by medicinal product manufacturers that have acceptable production facilities and equipment and a licence issued by Fimea. Wholesale trade in medicinal products is also subject to a licence issued by Fimea.

Fimea also monitors compliance with the stockpiling obligation regarding medicinal products. The Act on Compulsory Stockpiling of Medicinal Products (979/2008) applies to medicinal product manufacturers, medicinal product importers, health care units and the Finnish Institute for health and welfare

Questions related to guidance related to GMP-issues of medicinal manufacturers, are to be sent by e-mail to [email protected], wholesale dealer´s issues by e-mail to [email protected] and stockpiling obligation issues by e-mail to [email protected].