The detailed guidelines for the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (2010/C 17/01) require that the marketing authorisation holder (MAH) has to keep a document describing all changes planned during the life cycle of the medicinal product. The post approval change management protocol - approved by the regulatory authority - enables an early evaluation of the strategy for the change of the MAH. It is expected to lead to faster and more predictable implementation of post-approval changes.
To clarify frequently asked questions, the European Medicines Agency has published a Questions and Answers document on its position regarding the following 8 topics:
Please see the EMA Questions and answers on post approval change management protocols for more information as well as the detailed guidelines for the various categories of variation. You will find statements on post approval change management protocol on pages 14, 31 and 37.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)