When Can A Pharmaceutical Product Be Placed On the Market?
Eudralex Volume 2A was updated to Revision 9 in November 2018. Volume 2A of Procedures for Marketing Authorisation from the European Commission Health & Consumers Directorate – General states that a medicinal product may only be placed on the market in the European Economic Area (EEA):- when a marketing authorisation has been issued by the competent authority of a Member State for its own territory (national authorisation), or
- when an authorisation has been granted in accordance with Regulation (EC) No 726/2004 for the entire Union (this is known as a Union authorisation).