The Marketing Authorisation is described in the legislative framework
- EU Directive 2001/83/EC for the European Union
- US Directive Federal Food, Drug, and Cosmetic Act (FDCA)
- applies to all types of products
- 1 Marketing Authorisation (MA) = 1 Marketing Authorisation Holder (MAH)
The Marketing Authorisation Holder
- must have a legal address in the marketable area
- is legally accountable for Quality, Safety and Efficacy of the product
- is listed in the database Marketing Authorisation Holder Germany if there is minimum one product authorised in the German market
Manufacturing of the drug product
- can take place in- or outside the marketable area
- multiple manufacturing sites are allowed on the same Marketing Authorisation (MA)
- quality must be verified by Good Manufacturing Practice (GMP) status and inspection