CMDh/HMA: Best Practice Guide on Variations

Recommendation

17/18 September 2024

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

In July 2023, individual chapters of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" were updated and published on the HMA (Heads of Medicines Agencies) website. These include the following chapters:

• Chapter 4: CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure
• Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure
• Chapter 7: CMDh BPG on Worksharing
• Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines

In Chapter 4, amendments were made to paragraph 2.4. The Evaluation Process (Day 0 to Day 30) and in Chapter 5, additions were made to paragraph 7. Evaluation. The new passages in Chapter 7 were added in paragraph 6. The Procedure and in Chapter 9 the updates were made in paragraph 4.2. Second step - Submission of additional data (if requested).

The following addition was made in all chapters:

"The applicant should keep data synchronisation between modules 3-5 and module 1.2 during the procedure. In this respect, the applicant should submit an updated application form, each time the dossier information is modified in the context of response submissions."

This indicates that explicit care should be taken to ensure that the data entered in modules 3-5 and 1.2 are kept consistent during the procedure.

The new versions of the chapters of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" can be found on the HMA website.