New answers published about Variations: EMA's updated "Post-Authorisation" Guideline

On its website, the European Medicines Agency (EMA) offers a Q&A page which contains a collection of questions and answers on all regulatory activities linked to the issue of drug marketing authorisations. This Q&A page is usually updated on a short notice. Based on the regularity of new developments, a compilation of these questions and answers is published as a guideline entitled "Post-Authorisation Procedural Advice Human Medicinal Products". The document - available as a PDF file - contains all new regulations issued since the publication of the last version.

On 25 March 2011, the EMA published the 18th revision of the Post-Authorisation Guideline. Additionally, the respective changes on the Q&A page were updated. Following topics are addressed by the update:

  • How shall I present and submit my Type IA/IAIN Variation(s)? (See also GMP News from 6 April 2011)
  • How to obtain new EU sub-numbers for a Type IAIN/Type IB variation/submission? (This number must be requested before the notification or the submission)
  • In case of a transfer of marketing authorisation: can I include changes to the detailed description of Pharmacovigilance System?
  • How do I notify the EMA of changes to my contact persons specified in the application form? 
  • Can or must I submit my post-authorisation application in eCTD format?

The Post-Authorisation Guideline has a very extensive scope and covers almost all questions around the regulatory processes of post-authorisations. This guideline can be used as a reference document as well as the Q&Q page which is organised by topic.

Find more information in the Post-Authorisation Guideline

and on the Q&A page.

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

Go back

NEWSLETTER

Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.