March news updates from the EMA

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 1^st April (Link).
• New information pages on EMA:
  • Compliance (Link)
  • GMP (Link)
  • GDP (Link)
• 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).