07.02.2011

EU: CMD(h) releases updated version of the Q/A-list for the submission of variations according to Commission regulation (EC) 1234/2008

The Coordination Group for Mutual and Decentralized procedures - Human (CMD(h)) has released an updated version (CMDh/132/2009/Rev9) of the Q/A list for the submission of variations according to Commission regulation 1234/2008 ("New Variation Legislation"). Revision 9 from January 2011 of the Q/A list contains the following changes:

General questions (chapter 1):

New question 1.5 addressing the need to update the overall summary for any kind of type II variations: According to the updated Q/A list, an updated summary has to be submitted together with the other amended data.

Questions relating to the Classification of a variation (chapter 3):

Changes to the answer of questions 3.10 addressing the submission of a deletion of a pharmaceutical form or strength: Clarification has been added to the response as in case all strengths and pharmaceutical forms for one product are withdrawn, no variation is required. In this case the corresponding product must be withdrawn from the market in the concerned member states by submission of a withdrawal letter.
New question 3.15 added, detailing the requirements to submit a change in the name of a manufacturing site responsible for batch release and other activities: In this case a single type IA_IN variation application may be submitted as per scope A.5.a.

Questions regarding the approval and implementation of variations (chapter 5):

The answer to question 5.3,has been modified slightly. The question addresses the implementation date for a Type IA variation that has been submitted as part of a group containing a Type II variation. In this case the Type IA may either be implemented before submission or in case it should depend on the outcome of other changes as applied for in the grouped variation it may be submitted with an implementation data in the future. The change will then be implemented as soon as the complete grouped application has been approved.

Revision 9 of the Q/A list is available for download from the CMD(h) website in "clean" and "track-change" format.

[Source: CMD(h) website]

Links:

www.hma.eu/96.html

<- Back to: News Archiv