Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 December 2011
Press release
Veterinary
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for RevitaCAM 5 mg/ml oromucosal spray for dogs (meloxicam), from Abbott Laboratories Limited, for the alleviation of inflammation and pain in acute and chronic musculo-skeletal disorders in dogs.
The Committee adopted by consensus positive opinions for type II variation applications for:
- Posatex (orbifloxacin, mometasone furoate and posaconazole) – modification of the product information section 4.8 and section 6.2 concerning interactions and incompatibilities;
- Ingelvac CircoFLEX (Porcine circovirus type 2 orf-2 protein) – relating to the manufacturing process for antigen preparation.
Maximum residue limits (MRLs)
The Committee adopted by consensus an opinion recommending the extension of the current entry in table) of the Annex to Commission Regulation (EU) No 37/2010 for fenbendazole to chicken and the extrapolation of the MRLs to all food-producing species except fish.
Further to a request from Ireland under Article 27(2) of Regulation (EC) 470/2009, the Committee adopted by consensus an opinion recommending the extrapolation of the current MRLs for clorsulon to bovine milk.
Scientific advice
The Committee agreed scientific advice for a product intended to treat and control parasites in cattle and for a product intended to treat ear infections in dogs.
Pharmacovigilance
The Committee reviewed the periodic safety update reports (PSURs) for Circovac, CORTAVANCE, Equilis StrepE, Gripovac 3, PIRSUE, Profender, Reconcile, RESPIPORC FLU3, Rheumocam, STARTVAC, ZULVAC 8 Bovis and ZULVAC 8 Ovis and concluded that no further action or changes to their product literature were required.
Concept papers, guidelines and standard operating procedures
Quality
The Committee adopted questions and answers on the following quality topics:
- Stability issues of pharmaceutical bulk products for use in the manufacture of drug products;
- How to handle some harmonised Ph. Eur. Chapters under the new variations system (revised);
- Starting materials of herbal origin;
- The choice of primary packaging for sterile veterinary medicinal products.
The questions and answers will be published on the Q&A on quality pages on this website.
Environmental risk assessment
The Committee adopted a reflection paper on testing strategy and risk assessment for plants (EMA/CVMP/ERA/147844/2011) following the close of the public consultation. This reflection paper has been developed to address the recommended testing strategy and risk assessment for plants in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) environmental risk assessment phase II. The comments received during the consultation procedure have been taken into account for the revision of the reflection paper.
The reflection paper together with the overview of comments (EMA/521952/2011) will be published on this website.
Safety
The Committee agreed to release the draft guideline on risk characterisation and assessment of MRLs for biocides, following the adoption of the document in September 2011 for consultation with Commission services, for a 6-month period of public consultation (EMA/CVMP/90250/2010). This draft guideline presents the approach to be used in MRL applications and evaluations for pharmacologically active substances included in biocidal products for use in animal husbandry.
Replacement, reduction and refinement of animal testing (3Rs)
The Committee endorsed the Agency's report on the implementation of the possibility to waiving of the target animal batch safety test (TABST) for immunological veterinary medicinal products in the European Union, which is provided for by the European Pharmacopeia and CVMP guidance. The report addresses the efforts to waive the TABST among European marketing authorisation holders for veterinary vaccines. This paper discusses the main issues raised by the companies and gives an overview of the current situation regarding the number of products for which a waiver of the TABST was obtained.
This report will be published on this website.
International harmonisation
The Committee adopted the following draft VICH guidelines following their sign-off by the VICH steering committee for public consultation:
- GL34 on biologicals: Mycoplasma - Test for the detection of Mycoplasma contamination (EMA/CVMP/VICH/463/2002) – 3-month public consultation;
- GL50 on biologicals: Testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use (EMA/CVMP/VICH/582610/2009) - 6-month public consultation;
- GL51 on quality: Statistical evaluation of stability data (EMA/CVMP/VICH/858875/2011) - 6-month public consultation.
The guidelines will be published on this website.