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Showing 8011–8020 of 17962 articles for “Art. 5 avr. 2011”
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…
…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 sufficient data for the evalu…
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…
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