Under the Medicines Act (395/1987), 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.
Medicinal product manufacturer's licence
Under section 8 of the Medicines Act (395/1987), medicinal products may only be manufactured industrially by medicinal product manufacturers that have acceptable production facilities and equipment and a licence from the Finnish Medicines Agency Fimea. According to section 15a of the Medicines Act, medicinal products for clinical trials may be manufactured under a licence granted by Fimea in units complying with good manufacturing practice.
When applying for a licence for the industrial manufacture of medicinal products or the manufacture of medicinal products for clinical trials, the applicant shall submit to Fimea’s registrar’s office a free-form licence application including the documents and details listed in section 1 of the Medicines Decree. When applying for a licence pursuant to section 15a of the Medicines Act, administrative regulation 8/2019 of Fimea shall be taken into account.
Under section 17 of the Medicines Act, when importing medicinal products with a marketing authorisation or registered medicinal products intended for clinical trials of medicinal products from a state outside the European Economic Area, the importer must have the licence as referred to in section 8 for the industrial manufacture of medicinal products.
Under section 10 of the Medicines Act, a contract manufacturer of the manufacture of medicinal products and a contract analyst performing release analysis of active substances or medicinal products must have the licence as referred to in section 8. In this case, the details pursuant to section 1 of the Medicines Decree must be enclosed as applicable with the licence application.
A licence may only be issued if the company meets the requirements set in the EU Good Manufacturing Practice (GMP) for medicinal product manufacturers and has an accountable director as required under section 9 of the Medicines Act and at least one person who meets the qualification requirements laid down in Directive 2001/82/EC, 2001/20/EC or 2001/83/EC. An exception are manufacturers that manufacture only active substances, which are not required to have in addition to an accountable director a person meeting qualifications of a medicinal product manufacturer. The prerequisite for a medicinal product contract analyst is that it meets the requirements of the medicinal product manufacturer for quality control set in the EU Good Manufacturing Practice (GMP) and that an accountable director whose qualification requirements are laid down in section 9 of the Medicines Act and section 1a of the Medicines Decree is appointed for it.
The licence applies only to pharmaceutical forms or active substances specified in the licence. The licences of contract analysts of medicinal product manufacturers apply only to the techniques of analysis specified in the licence.
Companies that have been issued a licence under section 8 of the Medicines Act fall within the scope of Fimea's GMP inspections. Fimea's licences and inspections are subject to a charge. The charges payable for these services are determined in accordance with the Ministry of Social Affairs and Health Decree concerning activities of the Finnish Medicines Agency subject to fees.