Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022

Under Regulation (EU) 2019/6, the Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.0 of the QRD template for:

Equip WNV
Circomax – grouped procedure including deletion of the warning regarding the absence of safety data during pregnancy and lactation from the product information
Circomax Myo – grouped procedure including deletion of the warning regarding the absence of safety data during pregnancy and lactation from the product information.

The Committee adopted by consensus positive opinions for variation requiring assessment concerning quality-related changes for:

Arti-Cell Forte
Zenalpha

Under Regulation (EC) No 726/2004

The Committee adopted by consensus a positive opinion for an extension of the existing authorisation for Meloxoral (meloxicam), from Dechra Regulatory B.V., concerning the addition of a new pharmaceutical form for dogs.

The Committee adopted by majority a positive opinion for a marketing authorisation application for Mometamax Ultra (gentamicin/posaconazole/mometasone furoate), from Intervet International B.V., a new product for dogs intended for the treatment of otitis externa caused by mixed infections with bacteria susceptible to gentamicin and fungi susceptible to posaconazole.

Under Regulation (EC) No 1234/2008

The Committee adopted by consensus a positive opinion for a type II variation for Simparica Trio (sarolaner/moxidectin/pyrantel embonate) to update SPC section 5.1 regarding the onset of efficacy for Ixodes ricinus ticks.

The Committee adopted by consensus a positive opinion for a worksharing type II variation for Simparica and MiPet Easecto (sarolaner) concerning the addition of a new therapeutic indication for reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days after treatment.

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

Bovela (grouped)
Versican Plus Pi/L4R and Versican Plus DHPPi/L4R (worksharing procedure).

Withdrawal of applications

The Committee was informed of the formal notification from Zoetis Belgium SA of their decision to withdraw the application for an initial marketing authorisation for Versiguard SARS CoV2. More information about this application and the current state of the scientific assessment at the time of the withdrawal will be made available in a public assessment report. The document, together with the withdrawal letter from the applicant will be published on the Agency’s website in due course.

The Committee was informed of the formal notification from Orion corporation of their decision to withdraw the type II variation application concerning the addition of a new therapeutic indication for Sileo, for dogs. More information about this type II variation application and the state of the scientific assessment at the time of the withdrawal will be made available in a public assessment report. The report, together with the withdrawal letter from the applicant will be published on the Agency’s website in due course.

Maximum residue limits

The Committee agreed to amend the existing entry for pentaerythrityl tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009, under the heading of excipients, allowing for cutaneous use. This decision followed the Committee’s review of a request that had been submitted in accordance with the relevant CVMP guidance.

The Committee adopted the updated list of substances considered as not falling within the scope of Regulation (EC) No. 470/2009 - Rev. 55.

Scientific advice

The Committee adopted three scientific advice reports further to requests for initial advice. Two requests concerned immunological products and one concerned a pharmaceutical product. The respective target species were salmon (one product), cats and dogs (one product) and chickens (one product).

Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6

Following two requests, the CVMP classified:

A product (ATCvet classification: Immunologicals) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
A product (ATCvet classification: Alimentary tract and metabolism) for dogs was considered not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Union referrals and related procedures

The Committee started a procedure for the assessment of data generated in response to conditions applied to marketing authorisations for veterinary medicinal products containing moxidectin to be administered orally, topically or subcutaneously to cattle, sheep and horses. The conditions are laid down in Commission Implementing Decision (C(2017) 6577) of 25 September 2017, adopted following a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned products. Background information regarding the referral procedure, concerned products and details about the conditions is published on the Agency's website.

Regulation (EU) 2019/6

The Committee adopted a reflection paper on the criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6 (EMA/CVMP/116512/2021), following the close of the public consultation. The comments received during the consultation period (EMA/CVMP/352510/2022) were taken in to account in the finalisation of the reflection paper.

Organisational matters

The Committee appointed Ms Mary O’Grady and Dr Rory Breathnach as co-opted members to complement its expertise in quality and in clinical veterinary practice, respectively, for a 3-year mandate.

The Committee finalised the agendas for the Presidency CVMP and Joint CVMP/CMDv meetings to be held under the Czech Presidency of the EU, on 12-13 October 2022. The discussions will focus on revision of the CVMP benefit-risk guideline, signal management, pet parasiticides and environment, the EU/CVMP approach to contributing to VICH, data protection under Article 40(5) of Regulation (EU) 2019/6 and availability of veterinary medicinal products in veterinary practice.

More information about the above-mentioned medicines, including their full indications, guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”.