09.11.2010

EU: CMD(h) updates guidance documents for the submission of variations

The Co-ordination group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has updated a couple of guidance and explanatory documents concerning the submission of variations to marketing authorizations of medicinal products for human use.

The update concerns the following documents:

Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure: An additional explanation on the "Handling of Request and Cooperation with CMDv and EMA" was added in section 4 of chapter 8 in the guidance. See here for the "clean" and "track change" version of the new revision 10.
EMA/CMDh explanatory notes on Variation Application Form: Additional explanations on the term "unforeseen variation" have been added to the section "type of application" that is located on page 1 of the variation form. See here for the "clean" and "track change" version of the new revision 4
Examples for acceptable and not acceptable groupings for MRP/DCP products: The list for acceptable and non-acceptable groupings have been expanded with further examples. See here for the "clean" and "track change" version of the list.
Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008:
1. Question 2.10 Art. 30 Referral - Adpation of Commission Decision by TypIA_IN variation: Further explanations added on how to handle harmonisation of the Product Information only (by submitting a Type IA_IN C.I.1) and harmonisation of the Product Information and Module 3 information (by submitting a grouped Type IA_IN variation of C.I.1 and B.V.b.1.a)
2. New Question 3.14 added, explaining the term "manufactured by complex manufacturing process" for B.II.b.4
  
  See here for the "clean" and "track change" version of the Q&A List.

[Source: CMD(h) website]

Links:

www.hma.eu/96.html

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