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. 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. 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. Wholesale trade in medicinal products is also subject to a licence issued by Fimea. 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.
0 Comments
Leave a Reply. |