Article R5121-73
…d data collection protocols; 2° Summaries of the summary reports mentioned in Article R. 5121-70-1; 3° All opinions issued by the Agence nationale de sécurité du médicament et des produits de santé re…
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Showing 13841–13850 of 39711 articles for “Art. al. 3”
…d data collection protocols; 2° Summaries of the summary reports mentioned in Article R. 5121-70-1; 3° All opinions issued by the Agence nationale de sécurité du médicament et des produits de santé re…
For the application of 1° of Article R. 5121-26, where reference is made to published scientific literature, experts must justify the use of this bibliographical documentation and demonstrate that it…
…pean Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal pr…
…e use of the medicinal product or product; 2° The performance of post-authorisation safety studies; 3° Compliance with specific obligations regarding the recording or reporting of suspected adverse re…
…ion in general or specialised toxicology attested by a diploma and sufficient practical experience; 3° For the expert pharmacologist: a general or specialised qualification attested by a diploma and s…
…duct subject to prescription by virtue of its inclusion on one of the lists defined in article L. 5132-6 ; 2° Medicinal product subject to special prescription due to its classification as a narcotic…
Any measures taken by the holder of the early access authorisation issued for a medicinal product covered by 1° of II of Article L. 5121-12 to disseminate the authorisation, or any information relatin…
After the marketing authorisation has been granted, the authorisation holder must, with regard to the manufacturing and control methods, take account of scientific and technical progress and introduce…
…the 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 fo…
…e 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 has been provided. The…
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