CMDv report for release April 2017 - May 2017 now published

3 July, 2017

The latest CMDv report for release, giving an overview of the activities of the April and May 2017 meetings, has been published.  The report includes:

  • Statistics on VMPs reaching Day 90 (MRP) and Day 210 (DCP) in April and May 2017;
  • Planned agenda for the CVMP-CMDv Presidency meeting: role of the CMDv foreseen in the new veterinary regulations, impact of Brexit on the CMDv, and discussion of the ‘One Health’ approach: the meeting was held on 25th-27th June 2017;
  • Reference to joint guidance issued by CMDh and CMDv: Q&A for variations submitted according to Regulation EC 2008/1234 (Link), and examples of acceptable variation groupings (Link);
  • Response to questions from applicants to CMDv, including: data protection period for MAs obtained via 'Well Established Use’, clarification of the concept of 'Global Marketing Authorisation' as relating to data protection;
  • Announcement of a CMDv communication made to MAHs, regarding maintenance of product harmonisation following Article 34 referrals;
  • Clarification of requirements for B.III.1.a. variations to submit a new or updated CEP: covered by Q&A 3.17 in the variations Q&A document (Link);
  • Discussion on updated CLP pictograms and the updated ‘Blue Box’ Guideline (Link);
  • CMDv Membership changes and appointments;
  • Details of a query on the numbering of renewal documents, raised by IFAH-Europe, leading to subsequent update of the Best Practice Guide (Link),
  • Notification of a forthcoming CMDv website redesign, which is to be implemented stepwise;
  • Notification that an article on autogenous vaccines in Europe, written by the CMDv Member for France (Mariette Salery), has been published on the CMDv website and in Regulatory Rapporteur: (Link);
  • Notice to Applicants Vol 6A Chapters 1 (MAs - Link) and 3 (Referrals - Link), and Vol 6C (GMOs - Link), have been updated.

The full report can be accessed via the HMA website (Link).

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