Medicinal product manufacturer's licence
- Permit or other obligation
- Nationwide
- Public service
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), medic ...
Do the following
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.
To whom and on what terms
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.