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Portal Veterinary medicinal products
Technical changes relating to veterinary establishments
In accordance with Articles L.5142-2 and R. 5142-9 of the Public Health Code, any change of a technical nature to a veterinary pharmaceutical establishment must be the subject of a prior application to Anses (e.g.: The manufacture of a new pharmaceutical form or category of veterinary medicinal products, the extension or removal of premises in which pharmaceutical operations for manufacturing, import, distribution, storage, pursuit of a new activity are carried out, etc.).
Case of temporary absence of manufacture of veterinary medicinal products for mixed establishments (authorized by ANSM and ANMV) or restart of this activity
ANMV Doctrine for mixed manufacturing establishments not producing veterinary medicinal products on a temporary basis
In order to optimise the use of human resources for inspection according to risk, the ANMV is modifying its approach concerning mixed pharmaceutical establishments (authorised by the ANSM and the ANMV) authorised for the manufacture of veterinary medicinal products, wishing to keep their opening authorisation issued by ANSES despite a temporary cessation of production due to the absence of a manufacturing contract with a third party.
It is intended that:
1/ ANMV considers this temporary stoppage of production (due to the absence of a manufacturing contract with an MA holder) as a substantial modification of the opening authorisation, to be notified to it as soon as possible;
2/ After evaluation and approval of this change, the absence of production in the veterinary field is mentioned in the decision authorising the opening. From then on, ANSES no longer inspects this mixed manufacturer until it has restarted its production of veterinary medicinal products and, in the meantime, ANSES does not issue any new GMP certificate. The mixed manufacturer continues to provide an annual update of the state of the establishment (also known as the Site Master File);
3/ Restart of production of veterinary medicinal products linked to a new contract with a third party (e.g.: MAH) is considered a new substantial variation and must be declared by the manufacturer to ANSES.
4/ The amendment is evaluated by ANMV and leads to an update of the decision authorising the opening (i.e. withdrawal of the mention concerning the absence of production). An inspection of the mixed manufacturer shall be scheduled as soon as possible after the notification of the restart of production of the veterinary medicinal product. An updated GMP certificate may be issued upon completion of the inspection.
Amendments to the opening authorisation (of a technical nature) must be the subject of applications in accordance with Article 92 of Regulation 2019/6 and Article R. 5142-9 of the Public Health Code.