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Showing 8831–8840 of 19551 articles for “Art. CE 28-5-2010 n° 330567”
Where the application for marketing authorisation concerns a generator, it shall also include: 1° A general description of the system and a detailed description of the components of the system likely…
The application for marketing authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name and address of the f…
…1 must be accompanied by a dossier containing the following information and documents, updated as necessary, presented in accordance with the order referred to in Article R. 5121-11: 1° Chemical, phar…
When an application for authorisation concerns a generic medicinal product of a reference medicinal product which has not been authorised in France, the applicant must indicate the Member State of the…
…lication is compiled under the following conditions: 1° Where the applicant demonstrates, by reference to appropriate bibliographical documentation, that the application relates to a medicinal product…
…icinal products mentioned in articles R. 5121-25 and R. 5121-26 are considered to contain all the necessary and sufficient data for the evaluation of these medicinal products within the meaning of art…
The experts referred to in Article L. 5121-20 shall have the following qualifications and experience, as set out in a summary of the curriculum vitae attached to the marketing authorisation applicatio…
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…
For the application of the provisions of 1° of Article R. 5121-28, the Director General of the Agence française de sécurité sanitaire des produits de santé may exempt the applicant for a marketing aut…
…°, 2° or 3° of article R. 5121-28, prior to the marketing of the medicinal product or speciality concerned, of the fact that for some of the indications, pharmaceutical forms or strengths of the refer…
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