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Showing 7631–7640 of 39773 articles for “Art. R. 145-5”
Classification in the category of medicinal products for which prescription is reserved for certain specialist doctors has the following effects: 1° The prescription or initial prescription of the med…
A medicinal product may only be classified as a prescription-only medicine if the restrictions on prescribing are justified by the constraints involved in implementing the treatment, having regard to…
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…
…o training, unless the Chamber is informed that an expert opinion ordered in application of article R. 4221-15-4 is being carried out or has been carried out in the year preceding the registration of…
…e been heard. The decision shall state that the hearing was public unless the provisions of article R. 4234-25 were applied. In the latter case, it is stated that the hearing took place or continued w…
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…
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