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All medicinal products that do not fall within the scope of regulation EC no. The scientific assessment of the marketing authorisation applications is always performed by the competent national authority in Germany: Its research and control activities promote the quality, efficacy and safety of biological medicinal products.

Navigation and service Go to: To the Content To the Navigation Search. Verify. Gernany are here: Marketing Authorisation of Medicinal Products for Human Use General Competence of the Paul-Ehrlich-Institut Types of Procedure Further Information General Medicinal products that are to be marketed in Germany fundamentally require official approval for this in the form of a national marketing Gedmany or a marketing authorisation from the European Massage Lankwitz marylebone.

Medicinal products may be authorised through the following procedures: For the marketing authorisation of medicinal products containing a new active substance personalz for the treatment of a particularly serious disease, the Centralised European marketing authorisation is absolutely required.

The marketing authorisation is granted by the European Commission.

Article 3 2 of Regulation EC No. Further Information: