Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 November 2023
News
Veterinary
Medicines
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Equioxx
- Onsior
- Simparica Trio, Felisecto Plus, MiPet Easecto, Simparica, Stronghold Plus (worksharing procedure)
- Vectormune ND, Newflend ND H9 (worksharing procedure)
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:
- Credelio Plus
- Eravac
- Eryseng
- Eryseng Parvo
- Evalon
- Evant
- Hiprabovis IBR Marker Live
- Meloxoral
- Mhyosphere PCV ID
- Nasym
- Nobivac Myxo-RHD Plus
- Nobivac LeuFel, Leucogen (worksharing procedure)
- Rhiniseng
- Startvac
- Suvaxyn Circo+MH RTU
- Suvaxyn Circo
- Ubac
- Vepured
Maximum residue limits
The Committee agreed to include Varroa destructor calmodulin gene-specific double-stranded interfering RNA EP15 (naked unmodified dsRNA) as a new entry in the list of chemical-unlike biological substances not requiring a full MRL evaluation in accordance with Commission Regulation (EU) 2018/782 and adopted a revised list of chemical-unlike biological substances not requiring an MRL evaluation (EMA/CVMP/572629/2019–Rev.2). This decision followed the Committee’s review of a request that had been submitted in accordance with the relevant CVMP guidance.
Scientific advice
The Committee adopted one scientific advice report further to a request for initial advice which concerned an immunological product. The respective target species was turkeys.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following two requests, the CVMP classified:
- A product (ATCvet classification: alimentary tract and metabolism) for cats as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: musculo-skeletal system) for horses as intended for a limited market but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Concept papers, guidelines and SOPs
Environmental Risk Assessment
The Committee adopted a revised reflection paper on the environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs (EMA/CVMP/ERA/31905/2021) following the close of the public consultation. The comments received during the consultation procedure have been taken into account for the revision of the reflection paper. This reflection paper has been developed to communicate the CVMP's view on the scientific discussion regarding the potential environmental impact(s) of ectoparasiticidal veterinary medicinal products used in cats and dogs.
Refinement of animal testing (3Rs)
Following adoption by the CHMP, the Committee adopted a concept paper on the revision of the guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches (EMA/452614/2023) for release for a 3-month period of public consultation. This concept paper has been developed to allow revision of the guideline to provide, amongst others, more specific guidance on regulatory acceptance criteria for developers of microphysiological systems for specific contexts of use.
Quality
The Committee adopted an addendum to the guideline on the use of near infrared spectroscopy (NIRS) for a 6-week period of public consultation. The addendum has been developed to define changes that would be considered within the scope of the NIRS procedure and therefore maintained under GMP only, and those changes that would be considered outside of the scope of the procedure and therefore subject to a variation application.
Procedural announcement
Procedure for checking proposed (invented) names for veterinary medicinal products
From 1 January 2024, the number of invented name requests submitted for each marketing authorisation application will be limited to two. EMA’s analysis indicates that this reduction from four to two proposed invented names per request does not significantly impact the probability of achieving accepted names.
With this change, the procedure for checking proposed (invented) names for veterinary medicinal products will be more efficient, whilst reducing the number of unused agreed names. Furthermore, this amendment aligns with the current approach in the ‘Guideline on the acceptability of names for human medicinal products processed through the centralised procedure’.
It is important to emphasise that this decision has no impact on already submitted invented name requests, or already accepted invented names.
Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) will be updated shortly, whilst the revision is still ongoing of the ‘Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure’ is concluded.
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".