Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022
CVMP opinions on veterinary medicinal products
Under Regulation (EU) 2019/6
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Neoleish, from CZ Veterinaria S.A., a new vaccine for the active immunisation of Leishmania-negative dogs from 6 months of age to reduce the risk to develop an active infection and/or clinical disease after contact with Leishmania infantum.
- Rabitec – grouped procedure including update of the safety information in sections 3.5 special precautions for use, 3.7 use during pregnancy, lactation or lay, and section 3.9 administration routes and dosage of the SPC
- Versican Plus Pi/L4R
- Versican Plus DHPPi/L4R
- Aservo EquiHaler – grouped procedure including the update of the package leaflet following the outcome of the CVMP assessment of the 3rd PSUR
- Semintra - grouped procedure including merging the indications of Semintra 4 mg/ml and
10 mg/ml oral solution by re-arrangement of the already approved product information for both strengths, and other quality-related changes
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Lydaxx (2 procedures)
- Simparica Trio (2 procedures)
- Porcilis PCV M Hyo (subject to worksharing procedure)
- Simparica Trio
Maximum residue limits
The Committee agreed to include castor oil, hydrogenated (CAS No: 8001-78-3) as a new entry in the list of substances considered as not falling within the scope of Regulation (EC) No. 470/2009 under the heading of excipients and adopted an updated ‘out of scope’ list (Rev.56).
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following two requests, the CVMP classified:
- 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.
- A product (ATCvet classification: Antineoplastic and immunomodulating agents) for dogs as intended for a limited market and eligible for authorisation under Article 23 of
Regulation (EU) 2019/6.
Under Regulation (EU) 2019/6
The Committee adopted recommendations for changes to the summary of product characteristics for Solensia, Equilis Prequenza Te, Equilis Prequenza, Equilis Te, and Nobivac DP Plus as the outcome of signal detection activities.
Concept papers, guidelines and SOPs
The Committee agreed a revision of the incident management plan for medicines for veterinary use (EMA/711053/2010-Rev. 3) which was updated to reflect EMA organisational changes and legal references from Regulation (EU) 2019/6.
Regulation (EU) 2019/6
The Committee adopted a draft guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy (EMA/CVMP/NTWP/179287/2021) for a 3-month period of public consultation. This guideline has been developed to provide guidance on the requirements for developing and implementing a suitable potency assay or a combination of assays, which is linked to relevant biological properties of the cell-based product and further linked to the product’s clinical efficacy.
The Committee adopted a draft reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations (EMA/CVMP/64911/2021) for a 3-month period of public consultation. This reflection paper has been developed to provide an overview on the CVMP’s considerations to date on the development of scientific criteria to support the practical application of Article 40(5) of Regulation (EU) 2019/6.
The Committee adopted the mandate, objectives and rules of procedure for the European Sales and Use of Veterinary Antimicrobials Working Group (ESUVA WG – name to be confirmed), a new working group proposed to replace the voluntary ESVAC network.
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”.
- Apoquel: EPAR
- Aservo EquiHaler: EPAR
- Convenia: EPAR
- Equilis Prequenza: EPAR
- Equilis Prequenza Te: EPAR
- Librela: EPAR
- Lydaxx: EPAR
- Nobivac DP Plus: EPAR
- Onsior: EPAR
- Porcilis PCV M Hyo: EPAR
- ProteqFlu: EPAR
- ProteqFlu-Te: EPAR
- Rabitec: EPAR
- Rhiniseng: EPAR
- Semintra: EPAR
- Simparica Trio: EPAR
- Solensia: EPAR
- Versican Plus DHPPi/L4R: EPAR
- Versican Plus Pi/L4R: EPAR