CMDv report for release Dec 2016 - Jan 2017 now published

The latest CMDv report for release, giving an overview of the activities of the December 2016 and January 2017 meetings, is available to view and download (Link). The report includes the following regulatory updates:

• New recommendations for unforeseen variations:
  • Deletion of one of the authorised bulk or final containers
  • Addition of pharmacopoeia reference standards as replacement or alternative to the currently approved in-house reference standard
  • These recommendations are published on the CMDh website (Link)
• The CMDv and the CVMP adopted the revised QRD product information (PI) template v.8.1 at their November 2016 meetings.
  • The template v.8.1 with all official EEA language versions is published on the CMDv website (Link).
  • Within the updated template, the QRD group has developed a new template for ‘Particulars to appear on the immediate package – combined label and package leaflet’.
  • An additional Q & A has been published regarding SPC section 5.1, pharmacodynamics properties for pharmaceutical products (Link).
• Following the deletion of specified extraneous agents tests from the European Pharmacopeia for certain vaccine products, the CMDv endorsed that specific extraneous agents test on the final product can be withdrawn for the concerned products via a notification procedure. Please refer to the report for release for full details (Link).
• Following discussion, it was established that the vast majority of the Member States cannot accept the proposal to have different sets of product information under the same marketing authorisation i.e. specific dispenser set(s) and specific product information labelling for one of the target species.
• CMDv would like to clarify that the European Commission's Veterinary Team is working in close cooperation with the Biocide Standing Committee to ensure that divergent opinions amongst member states on classification of biocides / VMPs are avoided.
• The CMDv/BPG-007 on Handling Renewals in the Mutual Recognition and Decentralised Procedure is currently under revision.