Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 October 2024
News
Veterinary
Medicines
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Duotic (betamethasone acetate, terbinafine), from Dechra Regulatory B.V., a new product for the treatment of otitis externa associated with Malassezia pachydermatis in dogs.
The Committee adopted, by consensus, a positive opinion for a marketing authorisation application for Bravecto Triuno (fluralaner, moxidectin, pyrantel), from Intervet International B.V., a new product for the dogs with, or at risk from, mixed parasitic infestations by ticks or fleas, gastrointestinal nematodes, lungworm and/or heartworm.
The Committee adopted, by consensus, a positive opinion for a marketing authorisation for Vaxxon ND Clone from Vaxxinova International B.V., a new vaccine for the active immunisation of chickens from the age of day one to reduce mortality and clinical signs of disease caused by infection with Newcastle Disease virus.
The Committee adopted, by consensus, positive opinions for variations requiring assessment concerning quality-related changes for:
- Bovela
- Cortavance, Easotic (grouped)
- Enteroporc Coli AC (grouped)
- Poulvac Procerta HVT-IBD (grouped)
- Zycortal
The Committee adopted, by consensus, positive opinions for variations requiring assessment for:
- Bovilis Nasalgen-C – to indicate in the product information that Bovilis Nasalgen-C can be used during pregnancy.
- Eluracat (grouped) - to implement the outcome of the MAH’s signal management process and change a warning for use of the product in cats with hypersomatotropism (acromegaly) from the special precautions section of the product information to a contraindication and include the terms bradycardia and hypotension as new adverse events with a reporting frequency of very rare.
- Mometamax Ultra - to amend the instructions for use in the SPC and the package leaflet to indicate that the bottle must be shaken before each use.
Scientific advice
The Committee adopted a clarification of a previous scientific advice report further to a request from the developer of a veterinary medicinal product, concerning a biological product for cattle, pigs and sheep.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following two requests, the CVMP classified:
- A product (ATCvet classification: Respiratory system) for exotic animals as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 for the claimed indication.
- A product (ATCvet classification: Dermatologicals) for dogs as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Concept papers and guidelines
Efficacy
The Committee adopted a draft revised guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances (EMA/CVMP/EWP/755916/2016) for release for a 2nd period of public consultation (4-months). This guideline has been developed to provide guidance in relation to the documentation required to demonstrate the efficacy of veterinary medicinal products containing anticoccidial substances.
Quality
The Committee adopted a questions and answers document on Ph. Eur. general chapter 2.2.46 Chromatographic separation techniques.
The document above will be published on the Agency’s website after its adoption by the CHMP which is foreseen for their October meeting.
Legislation
The Committee adopted the following guidelines and overview of comments related to limited markets after close of public consultation:
- Guideline on quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets (EMA/CVMP/QWP/47285/2022) and overview of comments (EMA/CVMP/QWP/50888/2024),
- Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/SWP/32027/2022) and overview of comments (EMA/CVMP/SWP/46749/2024),
- Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/EWP/231668/2022) and overview of comments (EMA/CVMP/EWP/44280/2024),
- Guideline on safety and efficacy data requirements for applications for immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/IWP/224724/2022) and overview of comments (EMA/CVMP/IWP/53315/2024),
- Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets (EMA/CVMP/IWP/228730/2022) and overview of comments (EMA/CVMP/IWP/53990/2024).
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”.