Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 January 2012

Press release 13/01/2012

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for an initial marketing authorisation application under exceptional circumstances for Zulvac 1+8 Bovis, from Pfizer Limited, a vaccine for the active immunisation of cattle to prevent viraemia caused by bluetongue virus, serotypes 1 and 8.

The Committee adopted by consensus a positive opinion for a type II variation application for Easotic (hydrocortisone aceponate, miconazole, gentamicin) to modify the product literature in relation to new quality data and to add new presentations (single-dose package size).

Annual re-assessment of marketing authorisations

The Committee adopted positive opinions on the annual reassessments for BTVPUR AlSap 2-4 and Bovilis BTV8, further to the evaluation of the data submitted by the marketing authorisation holders to support the annual re-assessment. The Committee recommended the continuation of the marketing authorisations under exceptional circumstances for the veterinary medicinal products.

Community referrals and related procedures

The Committee started a procedure for Nuflor Swine Once 450 mg/ml solution for injection (florfenicol) from MSD Animal Health. The matter was referred to the Committee for arbitration by the reference member state Germany under Article 33(4) of Directive 2001/82/EC, as amended, due to concerns as to whether the efficacy of the product has been satisfactorily supported.

Scientific advice

The Committee agreed scientific advice concerning data requirements for an immunological product for cattle and follow-up advice for the development of a cardiovascular product for cats.

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 one product for a cardiovascular indication in dogs and two products for the same cardiovascular indication in cats, the CVMP considered that all three products were indicated for MUMS / limited market and were eligible for financial incentives.

Pharmacovigilance

The Committee reviewed the periodic safety update reports for Bovilis BTV8, Comfortis, Coxevac, Ingelvac CircoFLEX, Melovem, Meloxidyl and Rhiniseng and concluded that no further action or changes to their product literature were required.

Concept papers, guidelines and standard operating procedures

Efficacy

The Committee adopted a revised guideline on statistical principles for veterinary clinical trials (EMA/CVMP/EWP/81976/2010) following the close of public consultation. The elements of guidance have been amended in view of experience by regulators in recent years. The changes introduce mainly clearer guidance on issues relating to hypothesis testing (superiority, non-inferiority), confidence intervals for response variables, power calculations and other statistical methods. This guideline will replace the current guideline on statistical principles for veterinary clinical trials (EMEA/CVMP/816/00).

The document above will be available on the Agency's website.

Safety

The Committee adopted a draft guideline on the approach to establish a pharmacological ADI (EMA/CVMP/SWP/355689/2006) for a six-month period of public consultation. The guideline provides guidance on when to establish a pharmacological ADI and on the pharmacological studies and endpoints to be addressed when investigating the pharmacodynamic actions of a substance.

The document above will be available on the Agency's website.

Immunologicals

The Committee adopted a new guideline on data requirements for removing the target animal batch safety test for immunological veterinary medicinal products in the European Union (EU) (EMA/CVMP/IWP/810769/2011) following feedback from stakeholders and replacing the previous CVMP position paper on data requirements for removing the target animal batch safety test for immunological veterinary medicinal products in the EU (EMEA/CVMP/865/03/final). For an established vaccine the routine application of the safety test may be waived by the competent authority in the interests of animal welfare when a sufficient number of consecutive batches have been produced and found to comply with the test, thus demonstrating consistency of the manufacturing process. This guideline outlines the data requirements to be submitted by the marketing authorisation holder in order to waive the target animal batch safety test for the release of a batch of this product onto the market.

The document above will be available on the Agency's website.

Quality

The Committee adopted a revised guideline on the active substance master file (ASMF) procedure (EMA/CVMP/134/02-Rev.3) for a second two-month public consultation. The draft guideline has been revised further to take into account the revision to Annex I of Directive 2001/82/EC and also to introduce the concept of a unique version of an ASMF for one active substance valid for the whole EU / European Economic Area (EEA).

The Committee also adopted a revised guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations (EMEA/CHMP/CVMP/QWP/17760/2009-Rev.1) for a second three-month public consultation. The draft guideline has been significantly revised to take into account the extensive comments received during the first public consultation. The guideline will be published after its adoption by the Committee for Medicinal Products for Human Use, which is foreseen for their meeting to be held on 16-19 January 2012.

The documents above will be available on the Agency's website.

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