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Showing 6091–6100 of 24279 articles for “Art. 815-4”
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…
Each batch of veterinary medicinal products benefiting from a marketing authorisation referred to in article L. 5141-5 or a registration referred to in article L. 5141-9 is subject to control of the f…
Veterinary pharmaceutical establishments operate in accordance with the good practices mentioned in article L. 5142-3 which are applicable to them. In particular, they have : 1° Premises fitted out, a…
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…
Manufacturers of veterinary medicinal products mentioned in 1° of article R. 5142-1 must justify, at all times, that all the products they use, manufacture and deliver comply with the characteristics…
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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