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Showing 8091–8100 of 17962 articles for “Art. 5 avr. 2011”
…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…
For public health reasons, the Agence nationale de sécurité du médicament et des produits de santé may require a company to submit samples of each batch of the bulk product and the finished product fo…
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…
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