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Showing 5591–5600 of 36882 articles for “Art. Décret 2015-587 du 29-5-2015”
…one month are kept for a period of five years and are made available to the supervisory authorities during this period.
…operator on whose behalf it is acting. They may only distribute batches of veterinary medicinal products which have been released by the pharmacist or veterinarian responsible for the company which m…
When medicated feedingstuffs are manufactured for the purposes of a clinical trial, they are manufactured in accordance with the sponsor's instructions. The person responsible referred to 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…
…e or systems or kits referred to in Section 10 of this Chapter must follow, at his choice, the procedure relating to the EC declaration of conformity, full quality assurance system, or the procedure r…
Within the framework of the EC declaration of conformity procedure, product quality assurance, for class II a medical devices or class I medical devices, the provisions laid down in Article R. 5211-49…
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture,…
Before examining the application for assessment, the approved body will ensure that the file includes in particular : - the general characteristics of the applicant, such as company name, name, addres…
When the acquisition, possession and supply of veterinary medicinal products by the groups provided for in the first paragraph of article L. 5143-6 are carried out under the supervision of a pharmacis…
…each region, regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
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