Book I: Pharmaceutical products

In the companies referred to in article L. 5142-1, other than those which manufacture, import or distribute medicated feedingstuffs excluding any other veterinary medicinal product and which opt for the derogation provided for in the last paragraph of this article, the pharmacist or veterinary surgeon in charge is : 1° In public limited companies other than those referred to in articles L. 225-57 to L. 225-93 of the Commercial Code,…

The company sends the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail a copy of any document appointing the pharmacist or veterinarian in charge and the interim pharmacist(s) or veterinarian(s) in charge as defined in articles R. 5142-26 and R. 5142-27 and setting out their responsibilities. The company also sends a copy, as appropriate, to the competent central council of the national…

With a view to applying the rules laid down in the interests of public health, the pharmacist or veterinary surgeon in charge shall carry out the following duties insofar as they correspond to the activities of the company in which he works: 1° He/she organises and supervises all the pharmaceutical operations of the company, and in particular the supply, manufacture, advertising, information, pharmacovigilance, release, monitoring and withdrawal of batches, distribution,…

When the pharmacist or veterinary surgeon responsible for an establishment engaged in the manufacture, import or use of veterinary medicinal products, other than those subject to clinical trials, becomes aware, after a batch of veterinary medicinal products has been marketed, of an incident or accident which has occurred during the manufacture or distribution of that batch and which is likely to involve a risk to public health, it shall immediately…

If the competent body terminates the appointment of a pharmacist or veterinary surgeon as pharmacist or veterinary surgeon in charge, or refuses to renew the appointment when it expires, the pharmacist or veterinary surgeon may refer the matter to the central council of the competent section of the national order of pharmacists or the regional council of the order of veterinary surgeons, as appropriate. After hearing the views of both…