March news updates from CMDv

In what has been a very busy period for CMDv, numerous updates have been posted as summarised below:

• Recommendations for the manufacture, control and use of inactivated autogenous veterinary vaccines within the EEA (Link)
• CMDv summary report for 2016 (Link)
• Updated summary of national submission requirements
  • CMDv GUI-22 Format and number of copies for new marketing authorisation applications – updated with AT, RO, UK data and footnotes in March 2017 (Link)
  • CMDv GUI-23 Format and number of copies in post-authorisation procedures – updated with footnotes in March 2017 (Link)
  • Member States' additional national requirements for submissions – updated with document number in March 2017 (Link)
  • CMDv overview of Member States` requirements during national phase - updated with document number in March 2017 (Link)
• Worksharing for assessment of the ASMF
  • Following the successful completion of a pilot phase, the HMA agreed that the ASMF worksharing procedure is a standard procedure to be used (Link)
  • It is confirmed in the CMDv annual report that the use of the workshare procedure is endorsed for active substances in VMPs
  • Full details and the EU ASMF number request form can be found on the CMDh website (Link)
• Clarification Paper – Use of Pictograms on Labelling (Link).
• Updated Best Practice Guide (CMDv/BPG/007) for Handling Renewals in the Mutual Recognition and Decentralised Procedure (Link), together with the track changes version (Link)
• Updated Best Practice Guide (CMDv/BPG/006) for Type II Variations (Link), together with the track changes version (Link)