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Showing 9671–9680 of 29733 articles for “Art. CE 8-4-2022 n° 447694”
…hin a period set by the Agency, the results of which will be used to reassess the benefit/risk balance of the medicinal product as defined in the first paragraph of article L. 5121-9 ; 2° It must be p…
…dverse reactions and in the periodic safety update reports, as well as any authorised variations since the initial authorisation or the previous renewal. The content of the dossier is laid down by ord…
In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may prohibit the prescription and supply of a proprietary medicinal product and withdraw it from the mar…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application…
The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package le…
…ommittee responsible for proposing the list of approved products for public authorities, in accordance with the provisions of articles L. 5123-2 and L. 5123-3, is the Transparency Committee, the compo…
Pharmaceutical establishments operate in accordance with the good practices mentioned in article L. 5121-5 which are applicable to them. In particular, they have : 1° Premises fitted out, arranged and…
…acturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, distrib…
For the purposes of calculating the number of staff referred to in Articles R. 5124-38 and R. 5124-39, account is taken of persons engaged in the following operations: 1° Manufacturing and import oper…
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