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Showing 7951–7960 of 17844 articles for “Art. 815-5”
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 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…
The applicant is responsible for the accuracy and truthfulness of the documents and data supplied to the Agency when the application for marketing authorisation is submitted and during its examination…
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…
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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