Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7–9 November 2017
New NSAID to treat osteoarthritis pain in dogs
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for GALLIPRANT (grapiprant), from Aratana Therapeutics NV, a new non-steroidal anti-inflammatory product (NSAID) for the treatment of pain associated with mild to moderate osteoarthritis in dogs.
The Committee adopted, by consensus, positive opinions for type II variation applications for ERAVAC and Exzolt concerning quality changes.
The Committee adopted, by consensus, a positive opinion for a type II variation application, subject to a worksharing procedure, for Vectormune ND (and a product authorised nationally via MRP)concerning the addition of an associated use claim.
More information about the above mentioned medicines, including their full indication, will be published on the Agency's website.
Renewals of marketing authorisation
The Committee adopted, by consensus, a positive opinion for the renewal of the marketing authorisation for Semintra. The Committee, having re-assessed the benefit-risk balance of this product, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the indefinite renewal of the marketing authorisation.
Community referrals and related procedures
The Committee noted a request for re-examination of the CVMP opinion adopted on 5 October 2017 in the context of a referral procedure initiated under Article 34 of Directive 2001/82/EC for Girolan and its associated name Apralan (apramycin). The procedure will be initiated once the detailed grounds for the re-examination are submitted.
The Committee adopted, by consensus, a positive opinion recommending the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 for porcine prolactin in pigs.
The Committee adopted, by consensus, a positive opinion recommending the extension of maximum residue limits in accordance with Regulation (EC) No 470/2009 for eprinomectin in fin fish. Furthermore, and with reference to Article 5 of Regulation (EC) No 470/2009, the Committee agreed to recommend the extrapolation of the established MRLs for eprinomectin in ruminants to horses and rabbits.
More information about the above recommendations will be published on the Agency's website.
The Committee adopted one scientific advice report further to a request for an initial advice on safety and efficacy issues for a new anti-infective veterinary medicinal product for dairy cows.
Minor use, minor species (MUMS)/limited market
Following the Committee's review of a request for classification under the MUMS/limited market policy, the CVMP:
- classified a veterinary medicinal product (antiinfectives for systemic use) for rabbits as indicated for MUMS/limited market and eligible for reduced data requirements. No financial incentives will apply as authorised products already exist in the EU for the indications.
Following the Committee's review of a request for reclassification under the MUMS/limited market policy, the CVMP:
- reclassified a veterinary medicinal product (nervous system) for dogs, farmed foxes, cats and minks as indicated for MUMS/limited market and eligible for reduced data requirements. The product is not eligible for financial incentives as it is intended for use in a non-food-producing species.
The Committee reviewed the PSURs for Leucogen, Poulvac E.Coli, Trifexis, and Velactis and concluded that no further action or changes to their product information were required.
The Committee also reviewed the PSUR for Bluevac BTV8 and targeted PSUR for NexGard and recommended amendments to their product information.
Concept papers, guidelines and SOPs
The Committee adopted a draft revised guideline on pharmacokinetic studies in target animals (EMA/CVMP/EWP/133/1999-Rev.1) for a 6-month period of public consultation. The main objectives for a revision of this guideline are scientific developments in recent years, and considerations in regard to animal welfare issues.
The Committee adopted Questions and Answers to address the topic of tumorigenicity for the development of stem cell-based products for veterinary use.
Replacement, Reduction, Refinement of animal testing (3Rs)
The Committee adopted guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs (EMA/CHMP/CVMP/JEG-3Rs/94436/2014) and the overview of comments received during the public consultation (EMA/CHMP/CVMP/3Rs/83712/2017) following the close of the public consultation. The guidance was developed to facilitate the transfer of new methods validated in such trials with a view to implementing 3Rs for testing in a product specific context in laboratories originally involved in the collaborative trial or in new laboratories. The guidance and overview of comments will be published following adoption by the Committee for Medicinal Products for Human Use (CHMP).
The Committee adopted two separate Question and Answer documents to address the topics of preparation, management and assessment of PSURs and adverse event reporting.
The Committee adopted revised procedural advice to applicants/marketing authorisation holders on the re-examination of CVMP opinions.
The documents above will be published on the Agency's website.