Subsection 8: Operation and wholesale distribution of veterinary medicinal products.

Pharmaceutical establishments carrying out one or more of the operations making up the operation must have a documentation system comprising the procedures and records covering the operations they carry out and keep them for at least five years after the batch has been released or at least one year after the expiry date of the batches concerned. The operator shall keep the certificate of release or any document attesting to…

Any veterinary pharmaceutical establishment of a company mentioned in Article R. 5142-1 engaged in wholesale, free transfer or wholesale distribution shall keep, for each incoming and outgoing transaction, at least the following information: 1° The date of the transaction ; 2° The name of the veterinary medicinal product ; 3° The batch number and expiry date; 4° The quantity received or supplied; 5° The name and address of the supplier…

Any wholesale distributor, where he is not the marketing authorisation holder, who imports a veterinary medicinal product from another Member State shall inform the marketing authorisation holder and notify the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail of his intention to proceed with this import. The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and the holder of a marketing authorisation…

A company mentioned in 5°, 7° and 9° of article R. 5142-1 declares to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail the territory in which each of its establishments carries out its wholesale distribution activity. This declaration is made when the establishment opens; it is amended whenever the distribution territory initially declared changes. In the declared distribution territory, each veterinary…

A veterinary pharmaceutical establishment mentioned in article R. 5142-1 engaged in the wholesale, free transfer or wholesale distribution of veterinary medicinal products must have an emergency plan which guarantees the effective implementation of any withdrawal of batches of these medicinal products organised by the operator. This obligation applies under the same conditions to establishments engaged in the wholesale, free transfer or wholesale distribution of veterinary medicinal products undergoing clinical trials…

The depositories defined in 4° of article R. 5142-1 carry out their activities under the conditions set out in a written contract which, in accordance with the good practices provided for in article L. 5142-3 applicable to these activities, sets out the respective obligations of the depository and the operator on whose behalf it is acting. They may only distribute batches of veterinary medicinal products which have been released by…

Persons providing information by canvassing or prospecting for veterinary medicinal products, including medicated feedingstuffs, must meet one of the following qualification requirements: 1° Hold one of the diplomas, titles or certificates at least equal to level III registered in the national register of professional qualifications and appearing on a list drawn up by order of the ministers responsible for agriculture, health and higher education; 2° Hold one of the diplomas,…