Minutes of CVMP May and June 2017 meetings published

16 June, 2017

The EMA has posted the press releases with details of the CVMP's meetings of 10 – 12 May (Link) and 13 – 15 June 2017 (Link). General news relating to regulatory affairs includes:

Community referrals

  • The Committee concluded the referral procedure for VMPs containing moxidectin for cattle, sheep and horses, which related to a serious risk to the environment. The Committee concluded that overall the benefit-risk balance for the products is positive, subject to changes in the product information and conditions to the marketing authorisations.

Guidance adopted

    • Reflection paper on non-spontaneous adverse event reports (literature, internet and social media) for VMPs (Link), together with overview of comments (Link)
    • Updated combined VeDDRA list of clinical terms for reporting SARs in animals and humans to VMPs, together with revised guidance notes (not yet published)
  • ERAs: reflection paper on the authorisation of VMPs containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances (Link), together with overview of comments (Link)
  • ADVENT: Q & A regarding stem cell-based products for veterinary use: specific questions on sterility (not yet published)

Those adopted documents not yet available, will be published on the EMA website in the coming weeks.


Business Units: 

Environmental Risk Assessments

Our ecotox services include:

- ERAs to CVMP / VICH standards
- Responses to complex questions for MAAs
- Study design & management
- Phase I and Phase II (Tier A & B)
- Computer modelling (FOCUS)