Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 February 2013
The Committee adopted by consensus positive opinions for initial marketing authorisation applications for:
- Meloxidolor (meloxicam) from Le Vet Beheer B.V., an anti-inflammatory and antirheumatic product for dogs, cats, cattle, pigs and horses;
- Ecoporc Shiga from IDT Biologika GmbH, a vaccine for the active immunisation of piglets to reduce the mortality and clinical signs of oedema disease.
The Committee adopted by consensus a positive opinion for extension and variation applications of the existing authorisations for:
- Equilis Prequenza (vaccine against equine influenza) from Intervet International B.V., concerning a replacement of a strain and other changes in the quality of the product;
- Equilis Prequenza Te (vaccine against equine influenza and tetanus) from Intervet International B.V., concerning a replacement of a strain and other changes in the quality of the product.
The Committee adopted opinions on the annual reassessments for BTVPUR AlSap 1 and BTVPUR AlSap 1-8, further to the evaluation of the data submitted by the marketing-authorisation holder.
Since the specific obligations have been fulfilled, the Committee recommended the conversion of the Community marketing authorisations from under exceptional circumstances to a normal status for these two products.
Community referrals and related procedures
Further to the request of the European Commission following the consultation of the Standing Committee on Veterinary Medicinal Products, the Committee reconsidered its opinion on the referral procedure for Nuflor Swine Once 450-mg/ml solution for injection (florfenicol) adopted on 13 June 2012. The Committee, having reviewed the issues raised, revised the opinion and adopted an opinion by majority concluding that the application does not comply with Article 13 of Directive 2001/82/EC and consequently does not satisfy the criteria for marketing authorisation in respect to efficacy. Therefore, the Committee recommended the refusal of the granting of the marketing authorisation and the suspension of the existing marketing authorisations for Nuflor Swine Once 450 mg/ml solution for injection. The matter was initially referred to the Committee by Germany as the reference Member State in the decentralised procedure, under Article 33(4) of Directive 2001/82/EC due to concerns raised by Denmark relating to the efficacy of the product.
The Committee adopted by consensus a positive opinion recommending the establishment of maximum residue limits for diclazuril in rabbits.
The Committee adopted a revised list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 (EMA/CVMP/519714/2009-Rev.13) following consideration of several requests during the last months. The changes concern:
- modification of the maximum dose restriction for the excipient denatonium benzoate;
- inclusion of the substances PPG-2 myristyl ether propionate and polybutene under the heading 'excipients';
- introduction of a new heading 'biologically active constituents' with a new entry for 'stem cells'.
The Committee responded to three separate scientific advice requests concerning safety data requirements for an antiviral product for cats, and efficacy data requirements for an anti-inflammatory product for cats and for a diuretic product for dogs.
Minor use minor species (MUMS) / limited markets
Following the Committee's review of three requests for classification under the MUMS / limited-markets policy, which concerned an oncology product for horses and a product with digestive indications and an antibiotic both for dogs, the CVMP considered that the product for horses was indicated for MUMS / limited market and was eligible for financial incentives and that one product for dogs was indicated for MUMS but was not eligible for financial incentives as authorised products already exist for these indications.
The Committee reviewed the periodic safety update reports (PSURs) for Bluevac BTV8, Bovilis BTV8, Coxevac, Netvax, Nobivac Myxo-RHD, Profender, Purevax Rabies, Rhiniseng, Zulvac 1+8 Bovis and Zulvac 1+8 Ovis and concluded that no further action or changes to their product literature were required.
The Committee also reviewed the PSUR for Suprelorin and recommended changes to section 4.4 of the summary of product characteristics (SmPC) to amend a special warning already included in the product literature.
The Committee adopted the public bulletin on veterinary pharmacovigilance for 2012 summarising the Agency's activities regarding pharmacovigilance for veterinary medicinal products during the past year (EMA/CVMP/PhVWP/717241/2012). Annual public bulletins on veterinary pharmacovigilance are published by the Agency with the intention to improving communication to all stakeholders, but particularly to veterinary health professionals, on the surveillance of the safety of veterinary medicines in the European Union. The bulletin includes descriptive statistics on adverse events and safety updates, and provides an overview of the activities and issues addressed during 2012.
The document above will be available on the Agency's website.
The Committee adopted a revision to the joint Committee for Medicinal Products for Human Use (CHMP) / CVMP guidance document annexes to CPMP/ICH/283/95 impurities: guideline for residual solvents and CVMP/VICH/502/99 guidelines on impurities: residual solvents (CPMP/QWP/450/03-Rev.1 and EMEA/CVMP/511/03-Rev.1). Annex I of the document on specifications for class-1 and class-2 residual solvents in active substances had a sentence relating to class-2 solvents, which was the source of confusion, but has now been amended for clarification.
The document above will be published on the Agency's website after its adoption by the CHMP.
The Committee adopted a draft reflection paper on pharmacovigilance communication concerning veterinary medicinal products (EMA/CVMP/PhVWP/536313/2011) for a three-month period of public consultation. The reflection paper has been developed to provide an overview of practices and communication tools used, outline a basic framework for veterinary pharmacovigilance communication and improve and harmonise the approach to communication across the EU for transparent and effective transfer of pharmacovigilance information, particularly to veterinarians and other healthcare professionals and other 'users' of the veterinary medicinal products.
The reflection paper will be published on the Agency's website.
The Committee adopted a draft revised recommendation on harmonising the approach to causality assessment for adverse events to veterinary medicinal products (EMA/CVMP/PhVWP/552/2003–Rev.1) for a three-month period of public consultation. The former causality-assessment guideline was renamed as a recommendation and the content revised for consistency with volume 9B of the rules governing medicinal products in the European Union and to improve a harmonised approach for causality assessment.
The recommendation will be published on the Agency's website.
Further to the decision by the European Pharmacopoeia (Ph. Eur.) Commission of April 2012 to delete the target animal batch safety test (TABST) from the Ph. Eur. for nearly all veterinary vaccines with effect from 1 April 2013, it has been agreed to follow a notification procedure for centralised veterinary medicinal products, whereby marketing-authorisation holders will inform the Agency in writing of:
- the products for which they will withdraw the TABST in line with the Ph. Eur. requirements;
- the products for which the TABST will be renamed a residual toxicity test;
- the date on which the changes will be implemented (before 1 April 2013).
Marketing-authorisation holders and other stakeholders have been contacted and invited to notify the Agency in writing before 1 April 2013 of the products concerned.
- Bluevac BTV (previously known as Bluevac BTV8): EPAR
- Bovilis BTV8: EPAR
- BTVPUR: EPAR
- BTVPUR AlSap 1: EPAR
- Coxevac: EPAR
- Equilis Prequenza: EPAR
- Equilis Prequenza Te: EPAR
- Netvax: EPAR
- Nobivac Myxo-RHD: EPAR
- Profender: EPAR
- Purevax Rabies: EPAR
- Rhiniseng: EPAR
- Suprelorin: EPAR
- Zulvac 1+8 Bovis: EPAR
- Zulvac 1+8 Ovis: EPAR