Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 December 2021
News
Veterinary
Maximum residue limit
Medicines
The Committee adopted by consensus a positive opinion for a type II variation application for Bravecto 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 up to 12 weeks in dogs.
The Committee adopted by consensus a positive opinion for a type II variation application for Improvac concerning a change to the indication by adding suppression of oestrus in female pigs.
The Committee adopted by consensus, positive opinions for type II variation applications concerning quality-related changes for:
- Bravecto
- Cytopoint (grouped)
- Meloxidyl and Zeleris (subject to a work-sharing procedure)
- Mhyosphere PCV ID (grouped)
- Neocolipor (grouped)
The Committee adopted by consensus, positive opinions for type IB variation applications concerning quality-related changes for:
- Forceris (subject to a work-sharing procedure)
- Simparica, Felisecto Plus, Simparica Trio, MiPet Easecto and Stronghold Plus (grouped, subject to a work-sharing procedure)
- Vaxxitek HVT+IBD (subject to a work-sharing procedure)
Maximum residue limits
The Committee adopted by consensus a positive opinion recommending the extension of maximum residue limits for toltrazuril to poultry eggs. Toltrazuril is currently included in Table 1 (allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 with MRLs established for poultry tissues and all mammalian food producing species.
Scientific advice
The Committee adopted two separate scientific advice reports further to requests for initial advice, of which one concerned an immunological product and one was in relation to a pharmaceutical product. The respective target species were horses and cattle.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following three requests for classification relating to three veterinary medicinal products as intended for a limited market according to Article 4(29), and for eligibility for authorisation according to Article 23 (applications for limited market) under Regulation (EU) 2019/6, the CVMP classified:
- A product (ATCvet classification: Alimentary tract and metabolism) for dogs as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: Genito urinary system, gynaecological) for pigs (sows) as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: Immunologicals) for rabbits as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Pharmacovigilance
The Committee reviewed the PSURs for Bovela, CircoMax Myco, Coliprotec F4/F18, Nasym, Neptra, NexGard Combo, Porcilis Porcoli Diluvac Forte, Prevexxion RN+HVT+IBD, Profender, Reconcile and VarroMed, and concluded that no further action was required.
The Committee reviewed the PSURs for Fevaxyn Pentofel and Vectra 3D, and concluded that changes to their respective product information were required.
Concept papers, guidelines and SOPs
Efficacy
The Committee adopted a revised guideline on the summary of product characteristics (SPC) for antiparasitic veterinary medicinal products (EMA/CVMP/EWP/170208/2005-Rev.1) following the close of the public consultation. This guideline has been developed to provide SPC guidance mainly in relation to antiparasitic resistance. The comments received during the consultation procedure have been taken into account for the revision of the guideline.
The revision aims to provide clear harmonised text, with the purpose to promote a prudent and rational use of antiparasitic products. The guideline will replace the CVMP guideline on the summary of product characteristics for anthelmintics (EMEA/CVMP/EWP/170208/2005). The revision will come into effect on 1 July 2022.
International harmonisation
The Committee endorsed sign-off of the revised guideline VICH GL18 (R2) on impurities: residual solvents in new veterinary medicinal products, active substances and excipients, at step 4, for release for a 6-month period of public consultation following the sign-off by the VICH Steering Committee.
Organisational matters
The Committee adopted the revised procedural advice on appointment and responsibilities of the CVMP rapporteur, co-rapporteur in accordance with Article 140 (6) of Regulation (EU) 2019/6 and peer reviewer (EMA/CVMP/468877/2009 - Rev.3).
The Committee adopted the CVMP work plan for 2022 (EMA/CVMP/476954/2021), which highlights the priority areas for the Committee the coming year. The CVMP work plan for 2022 will be published on the Agency’s website.
The Committee appointed Dr. K. Baptiste and Dr. R. Carapeto as co-opted members to complement its expertise in antimicrobial/antimicrobial resistance and in environmental risk assessment, respectively, for a 3-year mandate.
Legislation
The Committee adopted a “Question and answer document” on the requirements for pre-clinical studies submitted in support of a marketing authorisation application for a veterinary medicinal product (EMA/CVMP/565615/2021), clarifying that compliance with GLP is only required for pre-clinical safety studies. The document will be published on the Agency’s website.
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”.