Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 May 2017
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus positive opinions for type II variation applications for Broadline (addition of new parasite species in the indications) and for Nobivac Bb and Vaxxitek HVT+IBD (quality changes). The Committee also adopted by majority a positive opinion for a type II variation application for Activyl (change in the legal status) for the target species dogs.
More information about the above mentioned medicines, including their full indication, will be published on the Agency's website.
Community referrals and related procedures
The Committee concluded the referral procedure for veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses. The matter was referred to the Committee by Germany under Article 35 of Directive 2001/82/EC, due to concerns that moxidectin may have persistent, bioaccumulative and toxic (PBT) properties, and consequently a potential serious risk to the environment may arise from the use of products containing the substance. The Committee adopted by consensus an opinion concluding that based on data from laboratory studies moxidectin fulfils the criteria for a PBT substance, and that the use of veterinary medicinal products containing the substance is posing a risk to aquatic and sediment organisms and to dung fauna. The Committee further concluded that these products are effective and an important therapeutic option in the treatment of internal and external parasites in cattle, sheep and horses; therefore in order to reduce and prevent as far as possible the identified risks for aquatic and sediment organisms and dung fauna, the Committee recommended risk mitigation measures and warnings to be included in the product information. The Committee further concluded that a targeted sampling in the environment following the use of veterinary medicinal products as a pour-on solution containing 5 mg moxidectin per ml or as a solution for injection containing 100 mg moxidectin per ml in beef cattle on pasture is necessary in order to obtain a better understanding of the actual environmental exposure, and, consequently, recommended conditions to the terms of the marketing authorisations. The Committee concluded that overall the benefit-risk balance for the products concerned by this referral is positive, subject to changes in the product information and conditions to the marketing authorisations.
Maximum Residue Limits
The Committee adopted by consensus a positive opinion recommending the inclusion of bromelain in table 1 of Annex to Regulation (EU) No 37/2010 with a “No MRL required” classification for porcine species.
More information about the above recommendation will be published on the Agency's website.
The Committee adopted one scientific advice report further to a request for an initial advice on quality, safety and efficacy issues for a veterinary medicinal product with a musculoskeletal disease indication for horses.
The Committee reviewed the PSURs for BTVPUR, BTVPUR Alsap 1, Cardalis, Convenia, Equilis Prequenza, Equilis Prequenza Te, Eryseng, Eryseng Parvo, Innovax ILT, Onsior, Porcilis ColiClos, Poulvac E. coli, Sileo, Suvaxyn Aujeszky 783 + O/W, Trifexis, UpCard, Velactis, ZULVAC 8 Bovis and ZULVAC 8 Ovis and concluded that no further action or changes to their product information were required. The Committee also reviewed the PSUR for Simparica and recommended amendment to the product information.
Concept papers, guidelines and SOPs
The Committee adopted a reflection paper on non-spontaneous adverse event reports (literature, internet and social media) for veterinary medicinal products (EMA/CVMP/PhVWP/357539/2015) following the close of public consultation. The reflection paper outlines aspects of handling of adverse events reported in peer-reviewed literature and other non-spontaneous sources e.g. on the internet. The comments received during the consultation procedure have been taken into account for the revision of the reflection paper.
The Committee endorsed for publication a reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances (EMA/CVMP/448211/2015) after adoption in April 2017 following the close of the public consultation and subsequent adoption by the Heads of Medicines Agencies (HMA). The reflection paper discusses the approach to the assessment of (potential) PBT and vPvB substances in veterinary medicinal and other products (chemicals, biocides, plant protection products), and also addresses the issues for consideration in the evaluation of veterinary medicinal products containing such substances under the current legislation and also the need for new legal provisions. The comments received during the consultation procedure have been taken into account for the revision of the reflection paper.