CMDv Report for Release published for meeting of October-November 2014

16 January, 2015

The full report for release can be found here and highlights are as follows:

  • Following a successful pilot phase, the CMDv has announced that the DDPS declaration can be used indefinitely by Applicants, for new MA Application dossiers containing a DDPS version which has already been approved by an EU Competent Authority in the context of a different application. 

Documents explaining the scope of the declaration, and a template for it, can be found here.

  • A joint CMDv/industry task force on variations was proposed during the October Interested Parties meeting, with the objective of reducing administrative burden.
  • The Veterinary Harmonisation Group on e-submissions is to gather information so as to have a global overview on the interpretations of E-signatures existing within the EEA.
  • A single 'Blue Box' document is to be published shortly by the CMDv, containing national requirements for packaging of VMPs authorised via all procedure types.
  • A revised Best Practice Guideline for MRP and DCP renewals was published by the CMDv on 7th November 2014.  A CMDv validation checklist for renewals of VMPs was published in October.