Article R5121-33
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…
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Showing 9151–9160 of 31040 articles for “Art. Cass. com. 22-5-2012”
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…
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.
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 articles mentioned in the left-hand column of the following table shall apply in New Caledonia, in the wording indicated in the right-hand column of the same table: Articles applicable In their wo…
The articles listed in the left-hand column of the table below shall apply in French Polynesia in the wording indicated in the right-hand column of the same table: Applicable articles In the wording r…
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