EMA's Current Positions on Transfer of a Marketing Authorisation

Like in many other branches, pharmaceutical companies have also often to face mergers. As a result of such fusions, marketing authorisations are almost always transferred to the new company i.e. to another legal entity. The transfer of such marketing authorisations raises some issues and questions about procedures and change management.
The EMA has recently published a number of current statements on its Q&A webpage to clarify these questions. You can find the answers to following questions:

  • What is precisely a transfer of marketing authorisation?
  • How shall I present my application for the transfer?
  • How and to whom shall I submit my transfer of marketing authorisation application?
  • How shall my transfer of marketing authorisation application be handled (timetable)?
  • How to choose the implementation date?
  • How to handle the change of the name of a medicinal product (INN + company name) as a result of the transfer?
  • Will there be any publication on the transfer of a marketing authorisation?

The EMA gives detailed and clarifying answers to these questions. The answer to the last question regarding the publication of a transfer of a marketing authorisation is short and clear: information about the change of a marketing authorisation holder can be found in the European Public Assessment Report (EPAR) of the respective drug product.

This assessment report is destined for the general public and summarises the effectiveness and features of a medicinal product which has received a Europe-wide marketing authorisation.

The questions raised and answered by the EMA regarding the procedure of a transfer of the marketing authorisation do not apply to marketing authorisations of orphan drugs. For the transfer of a marketing authorisation of an orphan drug, an extra application must be submitted in order to keep this status.

Find 

the complete answers of the EMA regarding the question of transfer of marketing authorisation.

Note: Receive first-hand information regarding marketing authorisation during the "Marketing Authorisation Procedures in the EU and the US"

conferences in Berlin, Germany, from 11-13 October 2011.

Author
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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