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Showing 8141–8150 of 18288 articles for “Art. 5 nov. 2014”
…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.
…ament et 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, c…
…s produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application for authorisation may only be rejected after the applicant has been invited…
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