Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:
- Comfortis (grouped variations)
- Purevax Rabies
- Purevax RCP FeLV, Purevax RCPCh, Purevax RCP and Purevax RCPCh FeLV (worksharing procedure)
- Versican Plus Pi/L4R and Versican Plus DHPPi/L4R (worksharing procedure)
- Versican Plus Pi/L4, Versican Plus Pi/L4R, Versican Plus L4, Versican Plus DHPPi/L4R and Versican Plus DHPPi/L4 (grouped variations, worksharing procedure).
Community referrals and related procedures
The Committee concluded the referral procedure for modified live porcine respiratory and reproductive syndrome (PRRS) virus vaccines. The matter was referred to the Committee by the European Commission under Article 35 of Directive 2001/82/EC due to concerns relating to animal health. The Committee considered that the risk of recombination of a modified live PRRS vaccine strain with other PRRS viruses is low and, additionally, identified risk mitigation measures to further decrease the risk of these events occurring in the future. The Committee adopted by consensus an opinion concluding that the benefit-risk balance of the concerned products remains positive and that the marketing authorisations should be varied in order to amend the product information to reflect the agreed risk mitigation measures.
The Committee adopted scientific advice reports for two pharmaceutical products further to a request for an initial advice and a request for a follow-up advice. The respective target species were dogs (one product), and sheep and goats (the other product).
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of a request for classification under the MUMS/limited market policy, the CVMP classified a product (ATCvet classification: Immunologicals) for turkeys as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as the market is not considered to be limited.
Following the Committee’s review of a request for reclassification under the MUMS/limited market policy, the CVMP also classified a product (ATCvet classification: Immunologicals) for cattle and goats as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is eligible for financial incentives as it is intended for use in a food producing species.
The Committee reviewed the PSURs for Galliprant, Kexxtone and Simparica Trio and concluded that changes to their product information were required.
The Committee also reviewed the PSURs for Baycox Iron, Evalon, Gumbohatch, Oncept IL-2, Palladia, SevoFlo, Suvaxyn Circo MH RTU and Zeleris and concluded that no further action or changes to their product information were required.
Concept papers, guidelines and SOPs
The Committee adopted a concept paper (EMA/CVMP/EWP/165592/2021) for the revision of the current CVMP guideline on the summary of product characteristics for anthelmintics (EMEA/CVMP/EWP/170208/2005) for a one month period of public consultation.
The Committee elected Jacqueline Poot as chair of the newly established CVMP Novel Therapies and Technologies Working Party for a 3-year mandate, and appointed a panel of members under the mandate, objectives and rules of procedure for said Working Party.
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'.
- Baycox Iron: EPAR
- Comfortis: EPAR
- Evalon: EPAR
- Galliprant: EPAR
- Gumbohatch: EPAR
- Kexxtone: EPAR
- Oncept IL-2: EPAR
- Palladia: EPAR
- Purevax Rabies: EPAR
- Purevax RCP: EPAR
- Purevax RCP FeLV: EPAR
- Purevax RCPCh: EPAR
- Purevax RCPCh FeLV: EPAR
- SevoFlo: EPAR
- Simparica Trio: EPAR
- Suvaxyn Circo+MH RTU: EPAR
- Versican Plus DHPPi/L4: EPAR
- Versican Plus DHPPi/L4R: EPAR
- Versican Plus L4: EPAR
- Versican Plus Pi/L4: EPAR
- Versican Plus Pi/L4R: EPAR
- Zeleris: EPAR