HMA / CMDv updates from July and August - Brexit, autogenerics, eSubmissions, the new veterinary legislation and more

12 August, 2018

In July and August the website of the Heads of Medicines Agencies (HMA) posted updated information relating to the coordination group for mutual recognition and decentralised procedures - veterinary (CMDv), including the latest report for release (Link), a report from the CMDv interested parties meeting of May 2018 (Link) and a report from the HMA meeting of June 2018 (Link).

CMDv report for release May / June 2018

Amongst other items discussed at the meeting, there were important updates regarding the following:

  • A summary of recent activity and updates relating to Brexit
  • A response to a question from industry regarding work-sharing procedures for a product and its “autogeneric”, belonging to the same MAH
  • The user guide for the electronic application form has been updated (Link)
  • A new recommendation for classification of an unforeseen variations (Link)
  • An updated version of the document ‘Exceptions to the VNeeS format’ has been published (Link)

Following an earlier meeting of the CMDv, minor changes and updates have been made to the "Best practice guide for changing the reference member state". The track changes version highlights the amendments (Link).

Interested parties meeting and HMA meeting

Key areas of discussion at the intersted parties meeting were: Brexit preparations; PSUR submissions through CESP; reduction in administrative burden relating to variations; the EMA SPOR project and the proposed mandating of Organisation Management Services (OMS) data in regulatory submissions by the end of 2018. Many of these issues were also discussed more briefly at the June HMA meeting, which covered the activity of both the CMDv and the CMDh. A short update on the new veterinary legislation was also provided.

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