Manufacturing medicinal products

To ensure the high quality of medicinal products, good manufacturing practice of medicinal products must be followed regardless of the place of manufacturing.

Administrative regulation 6/2011 issued by the Finnish Medicines Agency provides guidance on the good manufacturing practice of medicinal products in pharmacies, hospital pharmacies and dispensaries.

In addition, large-scale manufacturing of medicinal products must comply with the GMP guidelines of the EU (Guide to Good Manufacturing Practice for Medicinal Products), and these principles apply to all manufacturing of medicinal products.

Pursuant to Section 12 of the Medicines Act, Fimea must be notified of contract manufacture of medicinal products by the contract giver before starting the operations. Instructions for submitting the notification are provided in the National Agency for Medicines administrative regulation 6/2011, Section 9.3 Contract products.

Further information

  • Rosenberg Pirjo
    Senior Pharmaceutical Inspector tel. +358295223246