CMDv report for release June 2017 - July 2017 and ROG meeting reports now published

8 September, 2017

The latest CMDv report for release, giving an overview of the activities of the June and July 2017 meetings, has been published (Link).  The report includes news on:

  • CMDv composition & chair election
  • A new dedicated CMDv Brexit webpage (Link) with a notice to MAHs, a Q & A and the mandate of the CMDv Brexit working group
  • Clock start dates for 2018
  • Variations: updated examples of acceptable groupings (Link) and a variations submissions Q & A (Link)
  • CMDv pilot schemes: change in the name / address of the MAH; partial MAH transfers; Part II harmonisation
  • Use of US reference product for bioequivalence study
  • Variation classification: TSE certificate of suitability for bovine serum
  • ERA in repeat use application of an abridged dossier
  • Borderline product regulatory framework (Link)
  • Q & A on Authorisation of ectoparasiticidal products (Link)
  • Updated list of VMPs for bees (Link)
  • Minutes of the May interested parties meeting (Link)

In addition to the CMDv report for release, the HMA has also published the first two meeting reports from the Regulatory Optimisation Group (ROG): London, June (Link) and Amsterdam, September (Link).

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