Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022
Under Regulation (EU) 2019/6
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Lotilaner Elanco (lotilaner), from Elanco GmbH, a new antiparasitic product intended for use in dogs and cats.
The Committee adopted by consensus positive opinions for variations requiring assessment for Purevax RCPCh and Purevax RCPCh FeLV to align the product information with version 9.0 of the QRD template.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
Under Regulation (EC) No 1234/2008 the Committee adopted by consensus a positive opinion for a type II variation concerning quality-related changes for ProZinc.
Union referrals and related procedures
The Committee concluded the referral procedure for veterinary medicinal products containing toltrazuril to be administered orally to chickens. The matter was referred to the Committee by the Netherlands under Article 35 of Directive 2001/82/EC due to concerns relating to the appropriateness of the restriction periods between the administration and the start of the laying period. The Committee agreed that the restriction period before the onset of lay should be amended to ensure consumer safety. The Committee adopted by consensus an opinion concluding that the marketing authorisations of the concerned products should be varied in order to amend the product information accordingly.
Maximum residue limits
The Committee adopted the updated list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 – Rev.53.
The Committee adopted two scientific advice reports further to requests for initial advice, both concerning pharmaceutical products for dogs.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following four requests, the Committee classified:
- A product (ATCvet classification: Immunologicals) for sea bass as intended for a limited market but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: Immunologicals) for cattle, sheep and goats as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
The decisions on the requests for a product (ATCvet classification: Immunologicals) for turkeys and a product (ATCvet classification: Alimentary tract and metabolism) for dogs were deferred to the September 2022 CVMP meeting.
Under Regulation (EU) 2019/6
The Committee adopted regulatory recommendations including a Direct animal Healthcare Professional Communication (DaHPC) for Hiprabovis IBR Marker Live as outcome of signal detection activities.
Concept papers, guidelines and SOPs
The Committee adopted a concept paper on the revision of the guideline for veterinary medicinal products for zootechnical purposes (EMA/CVMP/EWP/222080/2022) for a 3-month period of public consultation. This concept paper highlights the changes which are considered necessary to the current guideline, based on regulatory experience, up-to-date scientific knowledge, and currently applicable legislation/terminology.
The Committee adopted a revision of the questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)) (EMA/CVMP/150343/2016-Rev.3), updating questions 4, 7, and 8 in relation to the frequency of adverse events.
Regulation (EU) 2019/6
The Committee adopted a draft guideline on the application of Article 34 of Regulation (EU) 2019/6 (classification of veterinary medicinal products - prescription status) (EMA/CVMP/273040/2022) for a 3-month period of public consultation. 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 appointed Dr Carina Bergman for a 3-year mandate, as a fifth CVMP co-opted member with the relevant scientific competence in toxicology and residues, following the election of the previous CVMP co-opted member (G. J. Schefferlie) as chair of CVMP in May 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'.