Article R5121-27
…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…
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Showing 7961–7970 of 17987 articles for “Art. 5 avr. 1978”
…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…
The processing authorised by article R. 333-5 may concern categories of personal data relating to:1° the identity of the person subject to the prohibition provided for in the first paragraph of articl…
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