EU: Best Practice Guide for the submission and processing of variations in MRP updated by CMD(h)

The CMD(h) - Coordination Group for Mutual Recognition and Decentralized Procedures - Human has relased an updated revision 9 of the "Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure". The version is available in "clean" and "track change" format.

Besides minor corrections the following changes were introduced in revision 9 (for details, see the "track change" version of the Best Practice Guide):

Chapter 5: Handling of variations in the MRP: Type II variations:

• Marketing Authorisation Holders should now send national translation of the Product Information (if applicable) within 7 days of the procedure ending (instead of 5 days as in previous version)

Chapter 8: Recommendations on unforeseen variations:

• Clarification of the scope: Purely national procedures are out of the scope until the Regulation 1234/2008/EC will be updated for purely national licences.
• Details added regarding the handling of request and cooperation with CMDv and EMA
• Flow chart for Recommendations on unforeseen variations updated in Annex to Chapter 8

[Source: CMD(h) website]

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