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Showing 1391–1400 of 64428 articles for “Art. 758-3 and 758-4”
…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…
…on 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 health or the envir…
…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…
…ted to present his observations. Rejection decisions must state the reasons on which they are based and indicate the appeal procedures and time limits applicable.
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…
…e mentioned in a of 1° of article L. 6111-2 may be authorised, in application of articles L. 6122-1 and L. 6122-2, to carry out care activities relating to obstetrics, neonatology and neonatal resusci…
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