Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023

CVMP opinions on veterinary medicinal products

Under Regulation (EU) 2019/6

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

Suvaxyn Circo+MH RTU
Galliprant
Bovela
Advocate
Nobivac Myxo-RHD Plus

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Purevax RC to align the product information with version 9.0 of the QRD template.

Scientific advice

The Committee adopted four scientific advice reports further to requests for initial advice concerning two pharmaceutical products and two biological products. The respective target species were swine (one product), dogs (one product) and cattle (two products).

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

Following three requests, the CVMP classified:

A product (ATCvet classification: immunologicals) for captive squirrel monkeys as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
A product (ATCvet classification: nervous system) for horses 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 horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers, guidelines and SOPs

Efficacy

The Committee adopted a new reflection paper on resistance in ectoparasites (EMA/CVMP/EWP/310225/2014). The comments received during the consultation procedure have been taken into account for the revision of the reflection paper. The reflection paper aims to give an overview of the known resistance of ectoparasites to active substances used in veterinary medicinal products with a special focus on Europe, and to provide a review of the current knowledge on resistance mechanisms, detection methods and possible control strategies.

Novel Therapies & Technologies

The Committee adopted a draft revised guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy (EMA/CVMP/NTWP/32862/2022) for a 4-month period of public consultation. This guideline has been developed to address the regulatory, technical and scientific basis applicable to the quality, safety and efficacy of phage therapy veterinary medicinal products where a variable composition of the final product is expected.

Safety

The Committee adopted a questions and answers document on the assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products (EMA/CVMP/SWP/32272/2022).

Regulation (EU) 2019/6

The Committee adopted the guideline on the application of Article 34 of Regulation (EU) 2019/6 (classification of veterinary medicinal products - prescription status) (EMA/CVMP/273040/2022). The comments received during the consultation procedure have been taken into account for the revision of the guideline. This guideline has been developed to elaborate on the scientific criteria within the various provisions of Article 34 of Regulation (EU) 2019/6 and to provide assessors and stakeholders with clear guidance for its consistent and predictable application.

The Committee adopted the procedural advice for vaccine platform technology master file (vPTMF) certification (EMA/CVMP/184591/2022). The comments received during the consultation procedure have been taken into account for the revision of the procedural advice.

Working parties

The Committee elected J. Mount as vice-chair of the Pharmacovigilance Working Party for a 3-year mandate.

The Committee adopted the work plans for 2023 for the CVMP Working Parties on Immunologicals (EMA/CVMP/IWP/820589/2022) and Safety (EMA/CVMP/SWP/618508/2022).

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”.