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Showing 2471–2480 of 42843 articles for “Art. R 314-4”
For any medicinal product authorised on the French market, each of its presentations and, where applicable, each common dispensing unit, is allocated a national identification number. This number is a…
The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
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…
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…
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