Article R5121-28
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 7681–7690 of 39714 articles for “Art. R 134-5”
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…
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 provisions of articles R. 3311-1 to R. 3311-3, R. 3312-3 to R. 3312-11, R. 3313-7, R. 3321-3, R. 3335-1 and R. 3341-1 à R. 3341-2-1.
If, at the end of the period provided for in the last paragraph of Article R. 1142-63-30, the persons considered liable by the College or their insurers have not made an offer of compensation to the c…
When the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail considers that the variation, suspension or withdrawal of a marketing author…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or the applicant for marketing authorisation may refer the matter to the European…
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