March news updates from the EMA

6 April, 2017

In addition to the CVMP’s March meeting report (Link), the EMA has published various other updates relating to the following topics:

  • Updates to “Quality of medicines questions and answers: Part 1” – three new Q & A added, relating to variations for the removal of heavy metals tests from a specification (Link).
  • MUMS/limited market for veterinary medicines – 7th Annual Report (Link).
  • Updated Q&A for Worksharing of variations - “How shall I present a variation application under worksharing?” (Link).
  • REMINDER: Updated fees for applications to the EMA Applicable as of 1st April (Link).
  • New information pages on EMA:
  • QRD template for combined label and package leaflet now published for consultation and trial use:
    • ‘Particulars to appear on the immediate package – combined label and package leaflet’ for VMPs authorised via the CP, MRP and DCP (Link).
    • Word versions of the new template in all official languages (Link).
    • Template for comments (Link).
  • New Q & A regarding GMP certificates and manufacturing authorisations (Link)
  • REMINDER: The use of XML delivery file is now mandatory for all veterinary electronic submissions via eSubmission Gateway/WebClient (Link).


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