The EMA has posted the press release with details of the CVMP's meeting of 6 – 8 December 2016 (Link). General news relating to regulatory affairs includes:
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.
Draft guidance released for consultation
- EFFICACY:
- Concept paper for the revision of the CVMP guideline on VMPs for zootechnical purposes
- Concept paper for the revision of the CVMP guideline on VMPs for fluid therapy in case of diarrhoea
Guidance adopted
- QUALITY:
- Q & A on removal of a general heavy metals test from a specification
- Q & A on improving the understanding of normal operating ranges, proven acceptable ranges, design spaces and normal variability of process parameters
- IMMUNOLOGICALS:
- revised guideline on requirements for the production and control of immunological veterinary medicinal products
- 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
- 3Rs:
- guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches
- 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)
- GENERAL REGULATORY:
- Implementation plan for QRD template v.8.1 for the centralised procedure
- 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
Working party elections
- Eva Lander Persson re-elected as chair of the Safety Working Party
- Esther Werner re-elected as chair of the Immunologicals Working Party
- Lisbet Vesterager Borge elected as chair of the PV Working Party
The adopted documents will be published on the EMA website in the coming weeks.
Also published by the EMA this week is the updated “Formatted table template to be inserted in application submission cover letters for veterinary procedures” (Link).
