Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 5-7 October 2021
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Imoxat, from Chanelle Pharmaceuticals Manufacturing Ltd., a new generic product containing imidacloprid and moxidectin for the treatment and/or prevention of mixed parasitic infections in cats, ferrets, and dogs.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Zenalpha, from Vetcare Oy, a new product to provide restraint, sedation and analgesia during conduct of non-invasive, non-painful or mildly painful procedures and examinations intended to last no more than 30 minutes in dogs.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Suiseng Diff/A, from Laboratorios Hipra, S.A., a new vaccine for the passive immunisation of neonatal piglets by means of the active immunisation of breeding sows and gilts to prevent mortality and reduce clinical signs and macroscopic lesions caused by Clostridioides difficile, toxins A and B and to reduce clinical signs and macroscopic lesions caused by Clostridium perfringens Type A, α-toxin.
The Committee adopted by consensus a positive opinion for an extension of the existing authorisation for Apoquel, from Zoetis Belgium SA, concerning the addition of a new pharmaceutical form for dogs.
The Committee adopted by consensus a positive opinion for a grouped type II variation application for NexGard Combo, from Boehringer Ingelheim Vetmedica GmbH, concerning the addition of new therapeutic indications for the treatment of notoedric mange (caused by Notoedres cati), the treatment of infections with Aelurostrongylus abstrusus (L3, L4 larvae and adults) and prevention of aelurostrongylosis in cats; and to support the safe use of the product in breeding, pregnant and lactating queens (female cats).
The Committee adopted by consensus a positive opinion for a type II variation application (subject to a work-sharing procedure) for Nobivac L4, from Intervet International BV, concerning the amendment of the product information to introduce the associated non-mixed use of Nobivac L4 with another related nationally authorised product.
The Committee adopted by consensus a positive opinion for a type II variation application for Reconcile, from Forte Healthcare Limited, to update the pharmacovigilance system.
The Committee also adopted by consensus a positive opinion for a type II variation application (subject to a work-sharing procedure) concerning quality-related changes for Vaxxitek HVT+IBD, Prevexxion RN+HVT+IBD and Prevexxion RN, from Boehringer Ingelheim Vetmedica GmbH.
Renewals of marketing authorisations
The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for VarroMed and Stronghold Plus. The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the indefinite renewal of the marketing authorisations.
The Committee adopted four separate scientific advice reports further to requests for initial advice of which two concerned pharmaceutical products and two biological products. The target species was dogs for all four products.
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of one request for classification under the MUMS/limited market policy, the CVMP classified a product (ATCvet classification: QI, immunologicals) for sheep, goats and cattle as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is eligible for financial incentives as it is intended for use in food producing species.
The Committee endorsed recommendations for changes to the summary of product characteristics for Bravecto Plus and Ubac as an outcome of signal detection activities.
The Committee reviewed the PSURs for Letifend, Purevax RC, Purevax RCP, Purevax RCP FeLV, Purevax RCPCh and Purevax RCPCh FeLV, and concluded that changes to their product information were required.
The Committee also reviewed the PSURs for Apoquel, Baycox Iron, Bovilis Blue-8, Clevor, Porcilis AR-T DF, Recocam and Respiporc FLUpan H1N1, and concluded that no action was required.
Concept papers, guidelines and SOPs
The Committee adopted draft revised guidelines on determination of withdrawal periods for edible tissues (EMA/CVMP/SWP/735325/2012), on determination of withdrawal periods for milk (EMA/CVMP/SWP/735418/2012) and on injection site residues (EMA/CVMP/SWP/185470/2004) for a
2-month period of public consultation. These guidelines have been revised to align with the new definition for withdrawal periods provided in Regulation (EU) 2019/6.
The Committee adopted a draft reflection paper on the interpretation of Article 72 of Regulation (EU) 2019/6 regarding environmental safety documentation and environmental risk assessment of certain veterinary medicinal products (EMA/CVMP/ERA/245311/2021) for a 3-month period of public consultation. This reflection paper has been developed to aid the procedure for harmonisation of the summary of product characteristics (SPC) for the reference products, aiming to align the SPCs of nationally authorised veterinary medicinal products.
The Committee adopted a concept paper, proposing updates to the CVMP’s reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/AWP/266787/2021) for a 3-month period of public consultation. This concept paper has been developed to address the need to review the status of these antimicrobial classes, in particular considering their importance to treat zoonotic campylobacter infections in humans and their ability to select for certain multi-resistance genes which have been detected in isolates from animals in Europe. Furthermore, both the (approved) indications and the volumes of use of these antibiotic classes have changed. Therefore, an update of the reflection paper is now recommended.
Regulation (EU) 2019/6
The Committee adopted a concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/435071/2021) for a 2-month period of public consultation.
EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2021 no later than Tuesday 30 November 2021. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 23 December 2021 and 2 January 2022 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by Monday 15 November 2021 for a start of procedure in 2021. For submissions received on or after 16 November 2021, the procedure will not start until early January 2022.
EMA is advising marketing authorisation holders to submit type IB and type IA variations for assessment under Commission Regulation (EC) No 1234/2008 no later than 20 January 2022, to ensure that the validation is completed on or before 27 January 2022. Any type IB variation which has not been validated by 27 January 2022 may need to be resubmitted as a variation requiring assessment under Regulation (EU) 2019/6. For guidance on variations requiring assessment and variations not requiring assessment please see the latest guidance available under Variations for veterinary medicines.
Marketing authorisation holders are advised to contact the veterinary applications team in advance of an upcoming submission at the following e-mail address: email@example.com.
More information about the above-mentioned medicines, including their full indications, guidelines, reflection papers, questions and answers and other documents, such as overviews of comments received during consultation, can be found below in 'Related content'.
- Apoquel: EPAR
- Baycox Iron: EPAR
- Bovilis Blue-8: EPAR
- Bravecto Plus: EPAR
- Clevor: EPAR
- Imoxat: EPAR
- Letifend: EPAR
- NexGard Combo: EPAR
- Nobivac L4: EPAR
- Porcilis AR-T DF: EPAR
- Prevexxion RN: EPAR
- Prevexxion RN+HVT+IBD: EPAR
- Purevax RC: EPAR
- Purevax RCP: EPAR
- Purevax RCP FeLV: EPAR
- Purevax RCPCh: EPAR
- Purevax RCPCh FeLV: EPAR
- Recocam: EPAR
- Reconcile: EPAR
- Respiporc FLUpan H1N1: EPAR
- Stronghold Plus: EPAR
- Suiseng Diff/A: EPAR
- Ubac: EPAR
- VarroMed: EPAR
- Vaxxitek HVT+IBD: EPAR
- Zenalpha: EPAR