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Showing 8301–8310 of 18177 articles for “Art. 5 oct. 2017”
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…
…lication file. When the Director General of the Agency makes use of the option granted to him under 5° of Article R. 5121-34, these time limits are suspended until the additional information required…
…he marketing authorisation lapses is counted from : 1° the date of publication of Decree No. 2008-435 of 6 May 2008 for marketing authorisations issued up to that date, with the exception of those for…
…roprietary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may…
…ic methods. These modifications must first be authorised under the conditions set out in article R. 5121-41-1.
…he national number identifying the presentation of the medicinal product provided for in Article R. 5121-4. It indicates, where applicable, the classification of the medicinal product in the following…
…n a medicinal product has obtained an initial marketing authorisation in accordance with Article L. 5121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 12…
…n or restriction intended to ensure the safe and effective use of the medicinal product or product; 5° The existence of an adequate pharmacovigilance system; 6° The performance of post-authorisation e…
1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du méd…
…management system as conditions of the marketing authorisation, in accordance with 1° of Article R. 5121-36-1.
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