News updates from EMA during November and December

15 December, 2017

In addition to the CVMP minutes of November (Link) and December (Link), the EMA has published updates relating to the following topics:


  • Report on the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines (Link)
    • Recommendations from the Joint EMA/HMA Steering Group on veterinary vaccine availability (Link)
    • AVC Presentation - Challenges in performing field trials to support efficacy: companion animal vaccines (Link)


  • Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (Link)
  • Updated: Member states contact points for translation review (v.6.9) (Link)
  • EMA-HMA BPG Measures to Improve Predictability of Submissions (Link)
  • New Q & As:
    • What logos / symbols can be included on the outer packaging of my VMP? (Link)
    • Type II variations: Introduction of a new manufacturing site for an active substance. What changes are covered by a single type II scope (Classification category B.I.a.1)?  (Link)
    • Type II variations: What changes to the product information (PI) can be included as part of one type II variation? (Link)
    • Type 1B variations: When applying for a new pack size, what is considered within the range/outside the range (classification category B.II.e.5)? (Link)


  • ADVENT – Allogenic mesenchymal stem cell-based products for veterinary use: specific questions on tumorigenicity (Link)


  • Draft guideline on conduct of pharmacokinetic studies in target animal species - Revision 1 (Link)


  • Q & A on Management and Assessment of PSURs (Link)
  • Q & A on Adverse Event Reporting (Link)
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