Article R5121-26
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…
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Showing 8861–8870 of 31009 articles for “Art. Cass. 3e civ. 31-5-2007 n° 06-12.907”
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…
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…
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…
When it is informed by the holder 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 c…
The information mentioned in article R. 6145-82 is made public on the establishment's website.
A university hospital centre which creates a subsidiary, takes control of a company within the meaning of article L. 233-3 of the Commercial Code or participates, directly or indirectly within the mea…
The budgetary and accounting year covers the period from 1st January to 31st December of the same year, except in the case of a new establishment coming into operation for the first time or a definiti…
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