The EMA has posted the press release with details of the CVMP's meeting of 17 – 19 May 2016 (Link). General news relating to regulatory affairs includes:
- An Article 35 referral was started for all VMPs containing methylprednisolone hydrogen succinate presented as solutions for injection for intramuscular use in cattle, relating to the withdrawal periods in cattle.
- The Article 35 referral for VMPs containing altrenogest to be administered orally to pigs and horses was concluded. Use in mares was considered to not present a risk to the environment; for use in gilts, it was concluded that a risk for fish and other aquatic organisms cannot be excluded for certain geographical areas. The Committee concluded that the overall benefit-risk balance for the concerned products for pigs is positive and recommended variations to the terms of the marketing authorisations.
- The referral for VMPs containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry was concluded. The CVMP recommended the withdrawal of the marketing authorisations for premixes for medicated feeding stuff and powders to be administered with the feed; the marketing authorisations for powders for use in drinking water should be varied in order to harmonise indications, dosing regimens and warning sentences on prudent use.
The CVMP adopted the updated advice on the use of colistin in animals prepared by the Antimicrobial Advice ad hoc Expert Group (AMEG). The request from the European Commission for the update of the advice followed the discovery the gene mcr-1 and the need to take into account the new information available.
Environmental Risk Assessments
The Committee adopted a draft guideline for consultation on the plant testing strategy for VMPs.
The Committee adopted a draft reflection paper for consultation on non-spontaneous adverse event reports.
The adopted documents will be published on the EMA website in the coming weeks.