A national registration procedure was created by Ordinance No 2022-414 of 23 March 2022 adapting national provisions to European Union law and in particular Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products derogating from the marketing authorisation.
The ANMV, in partnership with its line ministries, the Directorate-General for Health, the Directorate-General for Agriculture and the Directorate-General for Competition, Consumer Affairs and Fraud Control, organised on 28 August 2023 a webinar for professionals to present the conditions laid down in Regulation (EU) 2019/6, the submission of applications and the registration procedure, as well as the various stages of implementation of these provisions.
These products intended for small pets meet the definition of a veterinary medicinal product either because they are presented as having preventive or curative properties in relation to animal diseases, or because they contain active substances that exert a pharmacological, immunological or metabolic action in the animal or are administered to restore, correct or modify physiological functions.
In addition to the restrictive condition on target species, these medicinal products should not be subject to a veterinary prescription, which excludes antimicrobial drugs, narcotics and psychotropic drugs as well as veterinary medicinal products whose administration requires veterinary diagnosis. Member States must also take management measures to prevent their unauthorised use on other species.
The placing on the market of these registered veterinary medicinal products is accompanied by requirements laid down in the Regulation:
- their manufacture is carried out in an establishment with a Good Manufacturing Practice Certificate (GMP);
- they are subject to veterinary pharmacovigilance: the holder of the registration shall establish a pharmacovigilance system under the responsibility of a qualified person and ensure the collection and reporting of adverse events;
- advertisements for these veterinary medicinal products are subject to prior authorisation and are valid for 2 years.
- they are identified in the Union product database.
The sale to the end user may be carried out outside the pharmaceutical circuit in accordance with the provisions of II of Article L. 5143-2 of the Public Health Code and in particular in garden shops, pet stores and large and medium-sized stores.
With regard to online sales, this possibility is open to all non-prescription veterinary medicinal products, which includes registered veterinary medicinal products for new pets. The rules for physical issuance apply for online issuance. The online sales sites are declared to Anses and include the common European logo for the online sale of veterinary medicinal products.
See the page dedicated to online sales
Filings of applications for registration will be expected by the holders to the ANMV by 1 April 2024 (predicted date). In the meantime, the ANMV invites the holders of these veterinary medicinal products to send it a listing of the products on the market that would be affected by these regulatory measures.
Link to the recording of the meeting (in French)
Link to te meeting slideshow (in French)