Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 March 2022
Under Regulation (EU) 2019/6 the Committee adopted by consensus a positive opinion for an application for a variation requiring assessment concerning quality-related changes for Coliprotec F4/F18.
Under Regulation (EC) No 726/2004 the Committee adopted by consensus a positive opinion for a type II variation application for Advocate concerning the addition of a new therapeutic indication for the treatment of the lungworm Troglostrongylus brevior (adults) in cats.
The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:
- BTVPUR (grouped)
- Inflacam, Rheumocam (grouped, worksharing procedure)
- Porcilis ColiClos
- ProteqFlu-Te (grouped)
The Committee adopted three scientific advice reports further to requests for initial advice concerning two pharmaceutical products and one biological product, all indicated for dogs.
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 Atlantic salmon as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: Alimentary tract and metabolism) for horses as intended for a limited market but not 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 eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Under Regulation (EC) No 726/2004
The Committee reviewed the PSURs for Clevor, Cytopoint, Forceris, Leucogen & Nobivac LeuFel, Procox, and Veraflox and concluded that no further action was required.
The Committee reviewed the PSUR for Mhyosphere PCV ID and concluded that changes to its product information were required.
Concept papers, guidelines and SOPs
The Committee adopted a reflection paper on the interpretation of Article 72 of Regulation (EU) 2019/6 (EMA/CVMP/ERA/245311/2021), following the close of the public consultation. The comments received during the consultation procedure were taken into account. This reflection paper has been developed to aid the procedure for harmonisation of the summary of product characteristics (SPC) aiming to align the SPCs of nationally authorised veterinary medicinal products.
The Committee adopted a number of revised guidelines; the residues guidelines on determination of withdrawal periods for edible tissues (EMA/CVMP/SWP/735325/2012), determination of withdrawal periods for milk (EMA/CVMP/SWP/735418/2012), and injection site residues (EMA/CVMP/SWP/185470/2004). The comments received during the public consultation period for the respective guidelines were taken into account. These guidelines have been revised to align with the new definition for withdrawal periods provided in Regulation (EU) 2019/6 and will come into effect on 1 August 2022.
The Committee adopted the guideline on safety and residue data requirements for the establishment of Maximum Residue Limits (MRL) in minor species (EMA/CVMP/345236/2020) following the close of the public consultation. This guideline has been developed to clarify the data requirements for MRL applications for minor species. The comments received during the public consultation were taken into account for the revision of the guideline.
The Committee adopted a revised questions and answers on describing adverse events in the product information (SPC, labelling & packaging leaflet) (EMA/CVMP/150343/2016-Rev1). The Committee adopted the Veterinary Signal Assessment Report to be used by marketing authorisation holders to notify detected signals in the Union Pharmacovigilance database.
Regulation (EU) 2019/6
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”.