Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 8-9 September 2020

CVMP recommends maximum residue limits for a new active substance for use in fish

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a marketing authorisation for Librela (bedinvetmab) from Zoetis Belgium SA, a new product for the alleviation of pain associated with osteoarthritis in dogs.

The Committee adopted by consensus a positive opinion for a marketing authorisation for OvuGel (triptorelin acetate) from Vetoquinol S.A., a new product for the synchronisation of ovulation in sows.

The Committee adopted by consensus a positive opinion for a type II variation application for Cytopoint (lokivetmab) to add a new therapeutic indication for the treatment of pruritus associated with allergic dermatitis in dogs.

The Committee adopted by consensus a positive opinion for a type II variation application for Nobilis IB Primo QX to update the product information based on new data on the safe use of the product during the egg laying period.

The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:

• Zycortal;
• Nasym (grouped variation);
• Nobivac L4 and Canigen L4 (grouped variation under worksharing procedure);
• Suvaxyn Circo and Suvaxyn Circo+MH RTU (grouped variation under worksharing procedure).

The Committee adopted by consensus positive opinions for type IB variation applications (subject to a worksharing procedure) concerning quality-related changes for:

• Vectra Felis and Vectra 3D;
• Simparica and MiPet Easecto;
• NexGard Spectra, Afoxolaner Merial and NexGard.

More information about the above-mentioned medicines, including their full indication, will be published on the Agency’s website.

Community referrals and related procedures

The Committee concluded the referral procedure for veterinary medicinal products containing tiamulin hydrogen fumarate presented as premix for medicated feeding stuff and oral powder for in-feed use to be administered to pigs. The matter was referred to the Committee by Belgium under Article 35 of Directive 2001/82/EC due to concerns relating to the appropriateness of the indication and dosing regimen for prevention or metaphylaxis (when not associated with treatment) of swine dysentery caused by Brachyspira hyodysenteriae. The Committee adopted by consensus an opinion concluding that the available data is insufficient to support efficacy of the concerned products for this indication at the recommended dose, which was considered to pose a risk of ineffective treatment and antimicrobial resistance development. The Committee recommended the marketing authorisations of the concerned products to be varied in order to amend the product information accordingly.

Maximum residue limits

The Committee adopted by consensus a positive opinion recommending the establishment of maximum residue limits for imidacloprid in fin fish.

More information about the above recommendation will be published on the Agency’s website.

The Committee agreed to include sodium polynaphtalene sulfonate and sodium lauryl ether sulfate as new entries in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 under the heading of excipients. The Committee also agreed to correct the CAS Registry Number published for diethylaminoethyl (DEAE)-dextran in the list. A revised list (EMA/CVMP/519714/2009-Rev.45) was adopted. The decisions followed the Committee’s review of requests that had been submitted in accordance with the relevant CVMP guidance.

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

Scientific advice

The Committee adopted four scientific advice reports further to requests for:

• Initial advice on efficacy issues for a new veterinary medicinal product for metabolic disorders in horses;
• Initial advice on safety issues for a new immunological veterinary product for dogs;
• Follow-up advice on quality, safety and efficacy issues for a new veterinary medicinal product for musculoskeletal disorder indication in dogs;
• Initial advice on efficacy issues for the extension of an immunological veterinary product to dogs.

Minor use, minor species (MUMS)/limited market

Following the Committee’s review of a request for re-examination of a classification under the MUMS/limited market policy, the CVMP did not classify a product (immunological) as indicated for MUMS/limited market and the product was not therefore eligible for financial incentives.

Pharmacovigilance

The Committee reviewed the PSUR for Convenia and concluded that changes to the product information were required. The Committee also reviewed the PSURs for Equilis StrepE, Letifend, Forceris and Zolvix, and concluded that no further action or changes to their product information were required.

Working parties

The Committee adopted revised mandates, objectives and rules of procedure for the

• CVMP Safety Working Party (EMA/CVMP/SWP/131613/2004), and the
• CVMP Efficacy Working Party (EMA/CVMP/EWP/208686/2004).

Regulatory

At their plenary meeting in July, the CVMP endorsed the CMDv’s draft position paper (POS/CMDv/006) on procedural implementation of the revised European Pharmacopoeia requirements in relation to extraneous agents testing. The position paper, subsequently adopted by the CMDv at their plenary meeting in July 2020, covers the variation classifications that may apply to the deletion or revision of extraneous agents testing for live and inactivated vaccines.

Organisational matters

The Committee finalised the preparation of the Presidency CVMP meeting to be held under the German Presidency of the EU, on 20 October 2020. The meeting will focus on vaccine antigen master files and on implementation and reinforcement of the 3R principles.