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Showing 9651–9660 of 21091 articles for “Art. CA Paris 20-5-2009 n° 08-2432”
…icinal products mentioned in this article, the dossier attached to the marketing authorisation application is compiled under the following conditions: 1° Where the applicant demonstrates, by reference…
The dossiers provided in support of the application for authorisation of the medicinal products mentioned in articles R. 5121-25 and R. 5121-26 are considered to contain all the necessary and sufficie…
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…
…icinal products mentioned in this Article, the dossier attached to the marketing authorisation application is compiled under the following conditions: 1° Where the application concerns a generic medic…
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…
…he marketing of the medicinal product or speciality concerned, of the fact that for some of the indications, pharmaceutical forms or strengths of the reference medicinal product or speciality the inte…
For the application of 5° of article R. 5121-28, when reference is made to published literature recognised in the tradition of homeopathic medicine practised in France, experts justify, on the basis o…
The information mentioned in article R. 6145-82 is made public on the establishment's website.
…pates, directly or indirectly within the meaning of article L. 233-4 of the Commercial Code, in the capital of a company in application of article L. 6145-7, makes public the following information: 1°…
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