Mergers and acquisitions in the pharma industry have resulted in the need to transfer marketing authorizations (MAs) from the original MA holder to the new parent company. In mid-September, EMA updated a Q&A it created on this topic in 2007 to help provide guidance on the transfers. It does not apply to orphan drugs, which are handled in a different manner.
The Q&A now provides answers to the following additional questions:
● What is a transfer of marketing authorization?
● How shall I present my application for the transfer of marketing authorization?
● How and to whom shall I submit my transfer of marketing authorization application?
● How shall my transfer of marketing authorization application be handled (timetable)?
● How to choose the implementation date?
● How can I change the name of a product composed of INN + company name as a result of the transfer?