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:
Pharmacovigilance:
- The Committee adopted the bulletin on veterinary PV for 2016 summarising the Agency’s activities for the past year (Link)
Guidance for consultation:
- SAFETY:
- Assessment and control of DNA reactive (mutagenic) impurities in VMPs (Link)
- ECOTOX:
- Assessing the toxicological risk to human health and the environment from veterinary pharmaceuticals in groundwater (Link)
- PHARMACOVIGILANCE:
- Revised recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data for centrally authorised products (Link)
- MRLs & WITHDRAWAL PERIODS:
- 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:
- PHARMACOVIGILANCE:
- 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)
- REGULATORY:
- 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)
