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Showing 8051–8060 of 18288 articles for “Art. 5 nov. 2014”
By way of derogation from 2° of Article R. 5121-25, for the medicinal products mentioned in this article, the dossier attached to the marketing authorisation application is compiled under the followin…
…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 sufficient data for the evalu…
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…
By way of derogation from 2° of Article R. 5121-25, for the medicinal products mentioned in this Article, the dossier attached to the marketing authorisation application is compiled under the followin…
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…
…older of a marketing authorisation for a medicinal product granted under 1°, 2° or 3° of article R. 5121-28, prior to the marketing of the medicinal product or speciality concerned, of the fact that f…
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.
…rticle 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° The form, name and purpose of the company and the ad…
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