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Showing 3021–3030 of 43105 articles for “Art. R. 211-4”
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…
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…
Before dispensing any medicinal product, the pharmacist shall affix his name and address and the name of the medicinal product to the container, box or pack containing it. The provisions of this artic…
…ispensing of a pharmacopoeial preparation, its composition is replaced by the production order number. The registration systems allow, at the request of any control authority, immediate printing of th…
The pharmacist shall ensure that the conditions of transport are compatible with the proper storage of the medicinal products, products or articles mentioned in article L. 4211-1. He shall also ensure…
For the purposes of the third paragraph of Article L. 5125-25, a sealed package is any opaque package bearing the name of a single patient and sealed in such a way that the recipient can ensure that i…
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