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Showing 7671–7680 of 39714 articles for “Art. R 134-5”
The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescri…
Articles R. 741-11 relating to the rectification of material errors, R. 741-12 relating to the fine for abusive recourse, R. 742-2, with the exception of the last paragraph, and R. 742-4 to R. 742-6 r…
The decisions of the disciplinary chamber imposing a temporary or permanent ban on practising pharmacy or the orders of its chairman shall specify the period of enforcement or the date on which the pe…
I.-The decision shall contain the names of the parties, an analysis of the submissions and pleadings and a reference to the legislative and regulatory provisions to which it applies. The decision shal…
Where the application for marketing authorisation concerns a generator, it shall also include: 1° A general description of the system and a detailed description of the components of the system likely…
The application for marketing authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name and address of the f…
The application provided for in Article R. 5121-21 must be accompanied by a dossier containing the following information and documents, updated as necessary, presented in accordance with the order ref…
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…
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