CVMP December meeting press release published

22 December, 2014

The EMA has published the press release with details of the December meeting of the CVMP:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/12/news_detail_002232.jsp&mid=WC0b01ac058004d5c1

Significant regulatory updates include the following:

Colistin community referral: the referral procedure for all veterinary medicinal products containing colistin to be administered orally has been concluded. The marketing authorisations of the concerned products require variations in order to amend the product information accordingly.

Diclofenac residues: The procedure concerning the risk of diclofenac to vultures and other necrophagous bird populations in the EU was concluded. The CVMP is of the opinion that additional risk management measures are needed and efforts should focus on determining suitable and effective risk management measures.

Antibiotic resistance: the CVMP has now adopted the final answers to the 3 remaining questions asked by the European Commission regarding the impact of the use of antibiotics in animals. The answers will also be considered by the CHMP at their meeting on 15-18 December 2014. Following adoption by the CHMP the final answers will be submitted to the European Commission.

Guidance for immunologicals: a draft reflection paper was adopted for consultation on the replacement of cell lines used for the production of iVMPs. A second draft reflection paper was adopted for consultation on the use of heat treatment to inactivate retrovirus RD114 in live iVMPs.

ADVENT: The CVMP established a new ad hoc Expert Group on Veterinary Novel Therapies (ADVENT) and adopted a mandate and rules of procedure for this group. ADVENT consists of experienced regulatory scientists with a wide knowledge on the scientific aspects of VMPs and iVMPs and also on regulation of VMPs. ADVENT will be assisted by specialised topic groups as needed and a work plan for identification of topic areas will be adopted in early 2015.

 

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Will Drury Senior Business Associate
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