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Showing 7951–7960 of 17987 articles for “Art. 5 avr. 1978”
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…
…g, 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 the compl…
…ard. 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 without th…
Where an application for marketing authorisation in France is made for a medicinal product which has already been authorised or is the subject of an application for marketing authorisation currently b…
…f the risk-benefit balance of the medicinal product as defined in the first paragraph of Article L. 5121-9.
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…
When an application for authorisation concerns a generic medicinal product of a reference medicinal product which has not been authorised in France, the applicant must indicate the Member State of the…
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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