EMEA Publishes Updated Questions & Answers Guidance on Variations

GMP News
26 September 2007

EMEA Publishes Updated Questions & Answers Guidance on Variations

The section "Human Medicines - EMEA Post-Authorisation Guidance" comprises an updated version of the Q&A guidance on variations. Some of the Q&As related to variations Type 1 and Type 2 were revised in June 2007. Further parts of this Post Authorisation Guidance were added in August.

In addition to the Q&As related to variations other parts of this document provide answers to fundamental questions with regard to the authorisation of medicines. A new part published in August is related to Article 61 (3) "Notifications, Marketing and Cessation Notification".

Another interesting part, already published for some time, is the last section entitled "Other". In addition to others it also contains the question "Which EMEA inspection related activities may occur during the post-authorisation phase?"

Conference Recommendation:

The EU Commission is currently working on a new approach on Variations. This new approach will also have a major impact on API Manufacturers. A presentation from EU Commission as well as from Industry representatives will be part of the Regulatory Affairs Conference on Active Pharmaceutical Ingredients as part of the 10th API Conference on 24-26 October 2007 in Warsaw, Poland. For further details visit www.api-conference.org.

For more information please see the EMEA Post-Authorisation Guidance  
Prepared by:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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