Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 September 2011

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus positive opinions for type II variation applications for:

• Suprelorin (deslorelin acetate) – addition of ferrets as a target species.
• Suprelorin (deslorelin acetate) – quality changes.

Annual reassessment of marketing authorisations

The Committee adopted an opinion on the annual reassessment for Coxevac (inactivated Coxiella burnetii vaccine), further to the evaluation of the data submitted by the marketing authorisation holder. The Committee recommended the continuation of the Community marketing authorisation under exceptional circumstances for the veterinary medicinal product.

Renewals of marketing authorisation

The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for ProMeris (metaflumizone), ProMeris Duo (metaflumizone, amitraz) and Prac-tic (pyriprole). The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated.

Community referrals and related procedures

The Committee started a procedure for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names (praziquantel, pyrantel and febantel) from Chanelle Pharmaceuticals Manufacturing Limited. The matter was notified to the Committee by France under Article 34 of Directive 2001/82/EC, due to divergent decisions taken by Member States.

The Committee started a procedure for all long acting formulations for injection containing barium selenate for all food producing species. The matter was notified to the Committee by Germany under Article 35 of Directive 2001/82/EC, Community interest, due to concerns on safety of residues.

The Committee started a procedure to prepare a scientific opinion, under Article 30(3) of Regulation (EC) No 726/2004, regarding the substance dapsone. The matter was submitted to the European Medicines Agency by the Netherlands on a scientific matter concerning the evaluation of veterinary medicinal products. Dapsone 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) and was found as an impurity in certain veterinary medicinal products containing sulfamethoxazole.

Maximum Residue Limits

The Committee adopted by consensus a positive opinion recommending the establishment of maximum residue limits (MRLs) for tildipirosin in bovine, porcine and caprine species. This recommendation follows resolution of the outstanding issues identified by the Committee in its previous opinion recommending the establishment of provisional MRLs.

Further to a request in accordance with the CVMP guideline on data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009, the Committee adopted a revised list (EMA/CVMP/519714/2009-Rev.6), in order to include copolymer of polyvinylpyrrolidone and vinyl acetate under the heading of excipients.

Scientific advice

The Committee agreed responses to six requests for scientific advice concerning:

• the clinical development of a product for a medical condition in dogs;
• the clinical development of a product with a dermatological indication in dogs;
• the quality, safety and clinical development of a product with a dermatological indication in dogs;
• the safety studies for a product for bees;
• the clinical development of an immunological product for chickens;
• the quality, safety and MUMS data requirements for an immunological product for salmon.

MUMS / Limited markets

Following the Committee's review of two requests for classification under the MUMS/limited markets policy, which concerned products for reproductive treatment of cows and fluid therapy product for dogs, the CVMP considered that the products were not indicated for MUMS/Limited market and not eligible for financial incentives.

Pharmacovigilance

The Committee reviewed the PSURs for Acticam, Aivlosin, Bovilis BTV8, BTVPUR AlSap 8, Coxevac, Duvaxyn WNV, Easotic, Equilis StrepE, Netvax, Nobivac Piro, Porcilis AR-T DF, Reconcile, Trocoxil, Vaxxitek HVT+IBD and ZOLVIX and concluded that no further action or changes to their product literature were required.

Concept papers, guidelines and SOPs

The Committee adopted two revised guidelines on herbal medicinal products:

• Guideline on quality of herbal medicinal products/traditional herbal medicinal products (EMA/CVMP/814/00-Rev.2)
• Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products (EMA/CVMP/815/00-Rev.2)

Both guidelines have been updated by the Committee on Herbal Medicinal Products (HMPC) to reflect the current European Pharmacopoeial requirements and current relevant guidelines.

The documents will be published on the Agency's website.

International harmonisation

The Committee adopted a revised VICH guideline, GL18(R), on residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999-Rev.1) for implementation following its sign-off by the VICH Steering Committee.

The document will be published on the Agency's website.

Notes

• 'MUMS' stands for minor use minor species.