CMDv report for release Oct – Nov 2016 and other guidance updates

9 December, 2016

The HMA has published the CMDv’s October / November report for release (Link), with the following highlights:

  • A pilot for harmonising Part II (quality) of the VMP dossier is expected to start in early 2017.
  • The CMDv and CVMP adopted the English version of the revised QRD product information (PI) template v.8.1 at their November meetings, with publication of all language versions expected in early 2017.
  • A draft of the “QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products” was adopted by the CMDv and CVMP at their November meetings for consultation (Link).
  • CMDv has started discussions on an approach to follow regarding VMPs containing bacteriophage.
  • Reminder that the use of the VNeeS format will become mandatory for all submissions in European procedures (CP, DCP and MRP) 1Jan17.
  • CMDv checked the national fees links on the CMDv website for their update (Link).
  • Minutes of the May CMDv interested parties meeting have been published (Link).

CMDv has also published the following:

  • Updated: Member States' additional national requirements for submissions (Link) and overview of national requirements (Link).
  • Updated: CMDv GUI-23 Format and number of copies in post-authorisation procedures (Link).
  • Updated: CMDv GUI-22 Format and no. of copies for new MAAs (Link).
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