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Showing 5411–5420 of 36099 articles for “Art. s. 1304 to 1304-6 · Art. 1305 · Art. 2367 · Art. 1179”
…be renewed. Renewal is the subject of an application by the holder of this authorisation addressed to the Haute Autorité de santé, the ministers responsible for health and social security and, for ap…
…gence nationale de sécurité du médicament et des produits de santé an application for authorisation to market the genetically modified organism underArticle L. 533-5 of the Environment Code. The provi…
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…
…ioned in V of article L. 5121-12-1, the compassionate prescription framework is accompanied by a protocol for therapeutic use and patient follow-up. This protocol specifies in particular 1° The proced…
Where the therapeutic use and patient monitoring protocol so provides, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where appl…
…in accordance with the procedures set out in Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by layin…
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…
…ières de profession libérale de pharmaciens d'officine by merger or takeover, articles R. 5125-24-1 to R. 5125-24-5 are applicable.
Humanitarian wholesale distributors as defined in 8° of article R. 5124-2 are subject to compliance with good practice in the donation of medicinal products, set by order of the Minister for Health an…
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