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Showing 5231–5240 of 15144 articles for “Art. s. 413-6”
…isation is granted for a hybrid proprietary medicinal product of these proprietary medicinal products. For the purposes of application of these provisions, the Ministers responsible for health and soc…
…ticles R. 5121-69 and R. 5121-69-1, are applicable to decisions concerning the renewal of this access. The previous authorisation remains in force until the Haute Autorité de santé has taken a decisio…
When the application for early access authorisation concerns a medicinal product composed, in whole or in part, of genetically modified organisms, the holder of the exploitation rights, or his authori…
In the event of an additional request by the Haute Autorité de santé during the assessment of the application referred to in Article R. 5121-68, where applicable on a proposal from the Agence national…
I.-The maximum value of the period referred to in 1° of II of Article L. 5121-12 is set at two years from the date on which the authorisation referred to in this Article is granted. II.-The maximum va…
At the end of the procedures provided for in this sub-section, the marketing authorisation is issued or varied by the Director General of the Agence nationale de sécurité du médicament et des produits…
…horisation holder to subcontract, under a written contract, all or part of the monitoring of patients. For the implementation of the first paragraph of V of Article L. 5121-12-1 concerning healthcare…
…spensed it, the regional pharmacovigilance centres and, where appropriate, the poison control centres.
The pharmaceutical establishment of a company or organisation mentioned in Article R. 5124-2 engaged in wholesale, free transfer or wholesale distribution shall verify that the medicinal products rece…
For investigational medicinal products, the documents relating to each batch are kept by the pharmaceutical establishment which manufactures it, for at least five years after the end of the trial or t…
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