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Showing 4951–4960 of 36396 articles for “Art. Décret n° 2015-1437 du 5 novembre 2015”
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…
…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.
Repeated offences under article R. 5441-1 are punishable in accordance with articles 132-11 and 132-15 of the French Penal Code.
Members of commissions, committees, working groups and other expert collegiate bodies, as well as external experts used by the Agency and appearing on a list drawn up by the Agency's Director General,…
Repeated offences under article R. 5442-1 are punishable in accordance with articles 132-11 and 132-15 of the French Penal Code.
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