Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 July 2012
The Committee adopted by consensus positive opinions for type-II variation applications for:
- Suvaxyn PCV (porcine circovirus recombinant virus (cpcv) 1-2, inactivated) regarding manufacturing and quality of the product;
- Nobivac Myxo-RHD (live myxoma vectored RHD virus strain 009) regarding manufacturing;
- Suvaxyn Aujeszky 783 + O/W (vaccine against Aujeszky's disease in pigs) regarding manufacturing.
The Committee also adopted an opinion for grouped type II/IB variations for Onsior (robenacoxib) for a new indication for the solution for injection (treatment of pain and inflammation associated with orthopaedic surgery in cats) and also to include additional warnings in the product information.
The Committee adopted by consensus a positive opinion recommending the lifting of the suspension of the Community marketing authorisation for Suvaxyn PCV (porcine circovirus recombinant virus (cpcv) 1-2, inactivated) issued on 27 September 2010, further to the resolution of the concerns relating to a suspected potential for incomplete inactivation of the vaccine strain.
The Committee adopted opinions on the annual re-assessments for Zulvac 8 Bovis, Zulvac 8 Ovis and Zulvac 1+8 Ovis further to the evaluation of the data submitted by the marketing-authorisation holder. The Committee recommended the continuation of the Community marketing authorisations under exceptional circumstances for these veterinary medicinal products.
Community referrals and related procedures
The Committee concluded a procedure considering the implications in terms of animal health and the safety of consumers of the finding by the Dutch authorities of the substance dapsone as an impurity in certain veterinary medicinal products containing sulphamethoxazole and in particular with regard to the potential genotoxicity of dapsone. The procedure responds to the request from the Netherlands for the Committee to give a scientific opinion under Article 30 of Regulation (EC) No. 726/2004, taking into account the fact that this substance is included in table 2 of the annex of Commission Regulation (EU) No 37/2010 (previously annex IV of Council Regulation (EEC) No 2377/90) as a prohibited substance for use in food-producing animals. The Committee adopted by consensus an opinion concluding that:
- dapsone is not considered to be a direct genotoxic substance;
- carcinogenicity and clastogenicity seen in laboratory animals after long-term oral exposure to high doses of dapsone are most probably the consequence of a non-genotoxic mode of action;
- for consumers, the carcinogenic risk from residues from animals that have been treated with products containing sulfamethoxazole contaminated with dapsone is considered to be negligible;
- the carcinogenic risk for chicken, pigs and cattle is considered negligible;
- specific risk management measures with regard to dapsone as an impurity in veterinary medicinal products containing sulphonamides are therefore not required.
The CVMP will transit its opinion to the Netherlands and the opinion and assessment report will be made available on the Agency's website shortly.
The Committee started a procedure for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses (meloxicam) from CP-Pharma Handelsgesellschaft mbH. The matter was referred to the Committee by the Netherlands as the reference Member State in the decentralised procedure, under Article 33(4) of Directive 2001/82/EC due to concerns raised by Ireland and the United Kingdom relating to demonstration of bioequivalence of the product with the reference product for the target species, pigs.
The Committee started a procedure for Strenzen 500/125 mg/g powder for use in drinking water for pigs (amoxicillin trihydrate and potassium clavulanate) from Novartis Animal Health d.o.o. The matter was referred to the Committee by Czech Republic as the reference Member State in the decentralised procedure, under Article 33(4) of Directive 2001/82/EC due to concerns raised by the United Kingdom and the Netherlands relating to a potential risk to the environment from use of the product.
Maximum residue limits (MRLs)
The Committee adopted by consensus a positive opinion on the application for the extension of maximum residue limits for manganese carbonate to include parenteral use recommending, as a result, the deletion of the restriction of the current MRL entry 'for oral use only'.
The Committee agreed three separate scientific-advice requests concerning:
- safety and efficacy requirements for an immunological veterinary medicinal product for pigs;
- efficacy requirements for an oncology veterinary medicinal product for dogs;
- efficacy requirements for an anti-inflammatory product for dogs.
Minor use minor species (MUMS) / limited markets
Following the Committee's review of a request for classification under the MUMS / limited markets policy, which concerned an immunological product for sheep, the CVMP considered that the product was indicated for MUMS / limited market and was eligible for financial incentives.
The Committee reviewed the periodic safety update reports (PSURs) for Nobilis Influenza H5N2, Proteq West Nile, Purevax RCCh, Reconcile, Rhiniseng and Suprelorin and concluded that no further action or changes to their product literature were required.
The Committee also reviewed the PSUR for Stronghold and recommended the addition of a new adverse reaction in the product literature.
Following the withdrawal of a number of antiparasitic collars containing dimpylate (diazinon), propoxur and tetrachlorvinphos for companion animals in France, the Committee received a request from the CMDv to advise on the most appropriate approach to use in the user-safety risk assessment of flea collars containing these active ingredients. The CVMP Safety Working Party has been asked to provide advice.
The Committee adopted a revision of a question-and-answers document in relation to the CVMP guideline on the 'testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats' (EMA/CVMP/EWP/82829/2009). Additional information has been provided in regard to dossier requirements for generic topically applied veterinary medicinal products.
The updated question-and-answers document will be published on the Agency's website.
The Committee adopted a concept paper for revision of the CVMP guideline on harmonising the approach to causality assessment for adverse reactions to veterinary medicinal products (EMA/CVMP/PhVWP/5507/2011) for a 3-month period of public consultation. The concept paper was developed to revise the guideline for consistency with Volume 9B of the rules governing medicinal products in the European Union and to take into account advances in causality assessment in veterinary pharmacovigilance.
The Committee adopted a draft guidance on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicine (EMA/CVMP/ERA/52740/2012) for a 6-month period of public consultation. The draft guidance outlines the criteria for PBT/vPvB assessment for veterinary medicinal products and explains how the PBT/vPvB criteria under the guidance developed for industrial chemicals under the registration, evaluation, authorisation and restriction of chemicals (REACH) legislation should be interpreted for veterinary medicinal products and what testing strategy should be followed to complete the PBT assessment.
Application of 3Rs (replacement, refinement and reduction) in regulatory testing of medicinal products
The Committee adopted a recommendation to marketing-authorisation holders, highlighting the need to ensure compliance with 3Rs methods described in the European Pharmacopoeia (EMA/CHMP/CVMP/JEG-3Rs/252137/2012). The recommendation notes that Directive 2010/63/EU on the protection of animals used for scientific purposes requires the use of 3Rs methods where relevant methods exist, and notes that marketing-authorisation holders should therefore take action to ensure that their marketing authorisations are in compliance with this requirement.
The Committee adopted a revised concept paper on the need for revision of the position on the replacement of animal studies by in-vitro models (EMA/CHMP/CVMP/JEG-3Rs/169839/2011-Rev.1) for a 3-month period of public consultation. The concept paper was previously published as a Committee for Medicinal Products for Human Use Safety Working Party document. The purpose of the revision is to highlight that the scope of the work is expanded to cover medicinal products for veterinary use in addition to those for human use. The objective of the guideline is to establish a process for regulatory acceptance of all 3Rs testing paradigms.
The documents above will be available on the Agency's website.
The Committee adopted a revised safety guideline for implementation in the European Union following the sign-off by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products Steering Committee:
- GL36(R) on safety: Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI