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Showing 6481–6490 of 46939 articles for “Art. L 5314-4”
…vary the marketing authorisation must state the reasons on which it is based and indicate the appeal procedures and deadlines. Except in cases of urgency, the decision may only be taken after the mar…
Independently of decisions to suspend, modify or withdraw authorisations and as a precautionary measure, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'envi…
The procedures for submitting and examining applications for authorisation to open, for modification of initial authorisations and for transfer of authorisations to open, as provided for in articles R…
For the purposes of calculating the number of staff referred to in articles R. 5142-38 and R. 5142-39, account is taken of persons engaged in the following operations: 1° Manufacturing and import oper…
A veterinary pharmaceutical establishment which manufactures medicinal products mentioned in 1° of article R. 5142-1 has a documentation system comprising specifications, manufacturing formulae, proce…
When a pharmacist or assistant veterinarian recruited in application of article R. 5142-37 is absent or replaces the pharmacist or veterinarian in charge for a period of more than one month, he is rep…
The establishments referred to in article R. 5142-1 shall take all necessary measures to ensure that veterinary medicinal products are transported and delivered under conditions which guarantee their…
A manufacturer and importer of veterinary medicinal products mentioned in 1° and 2° of article R. 5142-1 has one or more quality control departments. This department or these departments are placed un…
As part of the EC declaration of conformity procedure, production quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the…
In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees…
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