The EMA has posted the press release with details of the CVMP's meeting of 6 – 8 December (Link).
Community referrals
- The Committee concluded the referral procedure for VMPs containing zinc oxide to be administered orally to food producing species. The Committee recommended the refusal of the granting of the MAs and the withdrawal of the existing MAs for VMPs containing zinc oxide.
Antimicrobial Resistance
- The Committee adopted a joint EMA and EFSA scientific opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the EU (RONAFA), and the resulting impacts on food safety.
The following documents adopted in the December meeting have now been published:
Draft guidance released for consultation
- EFFICACY:
- Concept paper for the revision of the CVMP guideline on VMPs for zootechnical purposes (Link)
- Concept paper for the revision of the CVMP guideline on VMPs for fluid therapy in case of diarrhoea (Link)
Guidance adopted
- MUMS- revised guidelines concerning data requirements for minor use and minor species:
- Quality (Link) and overview of comments (Link)
- Safety and residues (Link) and overview of comments (Link)
- Efficacy and target animal safety (Link) and overview of comments (Link)
- QUALITY:
- Q & A on removal of a general heavy metals test from a specification (not available at time of publication)
- Q & A on improving the understanding of normal operating ranges, proven acceptable ranges, design spaces and normal variability of process parameters (not available at time of publication)
- 3Rs:
- guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches (Link)
- GENERAL REGULATORY:
- Implementation plan for QRD template v.8.1 for the centralised procedure (not available at time of publication)
- Q & A document on the requirements for changing the classification from prescription-only status to non-prescription status for products authorised via the centralised procedure (not available at time of publication)
IMMUNOLOGICALS:
- revised guideline on requirements for the production and control of immunological veterinary medicinal products (Link) and overview of comments (Link)
- reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological VMPs (Link) and overview of comments (Link)
- VICH:
- VICH GL54: Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD) (Link)
The EMA has also published the 2017 work plan for its working parties, including the following:
- Pharmacovigilance working party (Link)
- Safety working party (Link)
- Environmental risk assessment working party (Link)
- Efficacy working party (Link)
- Antimicrobials working party (Link)
- Scientific advice working party (Link)
- Immunologicals working party (Link)
- ADVENT working party (Link)
