Minutes of CVMP Meeting 14 – 16 February 2017 published

17 February, 2017

The EMA has posted the press release with details of the CVMP's meeting of 14 – 16 February (Link). General news relating to regulatory affairs includes:


  • The Committee adopted the bulletin on veterinary PV for 2016 summarising the Agency’s activities for the past year (Link)

Guidance for consultation:

    • Assessment and control of DNA reactive (mutagenic) impurities in VMPs (Link)
    • Assessing the toxicological risk to human health and the environment from veterinary pharmaceuticals in groundwater (Link)
    • Revised recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data for centrally authorised products (Link)
    • VICH GL56: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods (Link)

Guidance for implementation:

    • The Committee adopted a risk management strategy for feline and canine vaccines with regard to potential presence of the replication competent feline endogenous retrovirus RD114 (Link)
    • Q & A document on the information to be included in section 5.1 of the SPC on pharmacodynamic properties for pharmaceutical products (Link)
    • Guidance document for applicants on oral explanations (Link)
Business Units: 

Unparalleled Expertise for EU Centralised Procedures

Cyton has a strong collaborative working relationship with Dr. Anja Holm of CVPC, former chair of the CVMP.

As well as providing unique insights into our clients' projects, our collaboration with Dr. Holm also includes regulatory training courses. Follow the links below for more information.
- Central VetPharma website
- Training event: Innovative VMPs