CMDv Report for Release September - October 2017 now available

10 November, 2017

The latest CMDv report for release, giving an overview of the activities of the September and October 2017 meetings, is available to view and download (Link). The report includes amongst other items:

  • Updated Q & A page on variations (Link)
    • 4.14 / 4.19 – How can MAs be adapted to the most current version of the SmPC, if the results of several procedures have to be considered?
    • 4.22 – How should I submit several changes to the pack size?
  • CMDv pilot on Part II harmonisation extended after successful procedure shows clear benefits to MAH and regulators
  • MRP transfer following a positive outcome of an Article 34 referral
  • Management of identical national and mutual recognition variations
  • Clarification on grouping Type 1A variations for  CP, MRP, DCP and NP products
  • Q&A regarding data protection periods for ‘Well established veterinary use’ products where the applicant has provided data to support the addition of new food-producing target species (Link).
  • Clarification of TSE data requests made at validation
  • Electronic application form for renewals to be updated to allow for simplified renewal procedure
  • Updated documents:
    • Text from NtA Vol 6A Chap 2 moved to CMDv website (Link)
    • List of CMDv members (Link)
    • BPG on Handling Renewals in the Mutual Recognition and Decentralised Procedure (Link)
    • BPG on Worksharing (Link), with track changes version (Link)
    • Classification of teat dips (Link)
    • Requirements on submissions for new MAAs (Link)
    • Q & A on authorisation of ectoparasiticidal products (Link)
  • Improvement of public assessment reports
  • EMA-HMA BPG Measures to Improve Predictability of Submissions (Link)
  • Minutes of Interested Parties Meeting October 2017 now published (Link), highlighting various discussions which have resulted in activities indicated in the report for release
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