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Showing 5961–5970 of 24279 articles for “Art. 815-4”
The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The appli…
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…
The committee 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…
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…
Manufacturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, di…
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…
When, for a period exceeding one month, an assistant pharmacist, recruited in application of articles R. 5124-38 or R. 5124-39, is absent or replaces the responsible or delegated pharmacist, he is rep…
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