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.
