Minutes of CVMP Meeting 14 – 16 March 2017 published

The EMA has posted the press release with details of the CVMP's meeting of 14 – 16 March 2017 (Link). General news relating to regulatory affairs includes:

Community referrals

• The Committee started a follow-up assessment procedure of the conditions on the MAs for VMPs containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys. Background information regarding the referral procedure is published on the Agency’s website (Link)
• The Committee concluded the referral procedure for VMPs containing methylprednisolone hydrogen succinate presented as solutions for injection for use in cattle. The Committee recommended the refusal of the granting of the MA for cattle and the variation of the existing MAs in order to remove any reference to use in cattle.
• The Committee concluded the referral procedure for VMPs containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. The Committee recommended variations to the terms of the marketing authorisations for in order to remove the indications ‘bovine mastitis caused by Mycoplasma spp.’ or ‘bovine mastitis caused by Mycoplasma bovis’ from the product information.
• The Committee considered the grounds for re-examination of the CVMP opinion for VMPs containing zinc oxide to be administered orally to food producing species. The Committee concluded that the recommendations included in their initial opinion should be maintained, recommending the refusal of the granting of the MAs and the withdrawal of the existing MAs for VMPs containing zinc oxide.

Guidance adopted

• ERAs: the Committee adopted a guideline on the plant testing strategy VMPs following the close of the public consultation (Link). The overview of comments were also published (Link).