Article R5141-44
The decision to suspend, revoke or 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 decisi…
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Showing 6071–6080 of 24797 articles for “Art. 4 mars 2021”
The decision to suspend, revoke or 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 decisi…
…en it appears : 1° Either, in particular following evaluation of the data mentioned in article R. 5141-90, that the medicinal product no longer satisfies the conditions mentioned in article L. 5141-6;…
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…
…de l'environnement et du travail and the inspectors and control officers mentioned in article L. 5146-1. The trials may not be the subject of any written or oral comment without the joint agreement o…
…initial authorisations and for transfer of authorisations to open, as provided for in articles R. 5142-5 to R. 5142-7, R. 5142-9, R. 5142-10, R. 5142-13 and R. 5142-14, as well as the content of the f…
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…
…pharmaceutical establishment which manufactures medicinal products mentioned in 1° of article R. 5142-1 has a documentation system comprising specifications, manufacturing formulae, procedures and st…
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…
…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 finished produc…
…armaceutical 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, arranged and m…
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