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Showing 1381–1390 of 64426 articles for “Art. 477 al. 3 and al. 4”
…tes to regional health policy through its opinions. These colleges include representatives of local and regional authorities, users and associations working in the areas for which the regional health…
I. - The articles L. 2313-1 to L. 2313-2 are applicable to the communes of French Polynesia subject to the adaptations provided for in II.II. - For the application of Article L. 2313-1:1° 8° is delete…
The costs of measures to validate acquired experience include the procedural and support costs determined by regulation.
…u médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and deadlines, automatically vary, suspend, for a period not exceeding one year, or withdraw a marke…
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…
…sation 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 application for renewal is…
…en examining the application for marketing authorisation, submit samples either of the bulk product and the finished product, or of one of them only. In the interests of public health, the Agence nati…
When, on the occasion of the implementation of Article 20(4) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, urgent action is essential to protect human…
…e 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 market on the grounds mention…
…des produits de santé.The application must include the information specified in Article R. 5121-21 and must be accompanied by a dossier comprising :1° A copy of the marketing authorisation, certified…
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