CMDv Report for Release November - December 2017 now available

19 February, 2018

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

  • Updated Q & A related to the UK's withdrawal from the EU with regard to national authorised VMPs (Link).
  • Revised Q&A List for the Submission of Variations (Link). Q2.2 update initiated by CMDv.
  • Combined CMDv / CMDh Q & A on the QP Declaration (Link).
  • Response to a question regarding the applicant’s withdrawal from Type IB / II variations (see RfR).
  • Updated BPG for ‘Submission of high quality national translations’ (Link).
  • Advice on zero day withdrawal period when no MRL exists (see RfR).
  • Clarification that MUMS classification requests should be submitted to the CVMP, even for product not intended for the CP (see RfR).
  • CMDv is evaluating proposals from Animal Health Europe for eight new animal species pictograms (see RfR).
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