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)

Note: The ECA Education Course "

Handling Changes and Variations" in Prague, Czech Republic, from 10-11 May 2011 will focus on the changes in marketing authorisation dossiers.

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