EU: EMA releases new revision of the Post-Authorisation Procedural Advice

The European Medicines Agency (EMA) has released a new version (revision 17) of the "Post-Authorisation Procedural Advice Human Medicinal Products". 

This guidance document addresses a number of questions which Marketing Authorisation Holders may have on post-authorisation procedures for human medicinal products in the EU centralized procedure. It provides an overview of the EMA's position on issues, which are typically addressed in discussions or meetings with Marketing Authorization Holders in the Post-Authorisation phase.

The newly released revision 17 was required to reflect current practice with new Regulations, especially the new EU Variation Regulation, and to correct the numbering system for worksharing / grouping of variations. Changes in the new revision are numerous and affect the following sections /questions (Q) (taken from the "Table of revisions"):

• Type IA Variations: Q3, Q4, Q6, Q10, Q11, Q13
• Type IB Variations: Q4, Q5, Q7, Q9
• Type II Variations: Q12
• Type II Variations/Extension applications: Q11
• Grouping of Variations: Q4, Q5, Q7, Q8
• Worksharing: Q3, Q4, Q5,Q6, Q7, Q8, Q9, Q10
• Follow-up Measures (FUMs)/Specific Obligations: Q3

The Post-Authorisation Procedural Advice is available as "integrated" PDF document and corresponding online Q&A website. The last update has been published in June 2010 (see our related News article)

[Source: EMA website]

Related News:

 EU: New revision of the Post-Authorisation Procedural Advice for the Centralized Procedure released by EMA - 28.03.2011 14:21

 EU: EMA releases new revision of the Post-Authorisation Procedural Advice for Human Medicinal Products - 13.06.2010 15:45

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