MEB 15: Replica marketing authorisation (only apply to existing marketing authorisations)

A replica marketing authorisation concerns a medicinal product which is exactly the same as the reference medicinal product, with the exception of the following information that specifically applies to the replica marketing authorisation: the product name, the name and address of the marketing authorisation holder, and the registration number. The replica marketing authorisation has no SmPC of its own.

Since 2003 it is no longer possible to obtain a marketing authorisations via the replica marketing authorisation procedure. The marketing authorisation for replica products which have already been issued remain valid, unless one of the situations applies as described on page 3 of the policy document.