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Showing 1601–1610 of 37083 articles for “Art. R 418-7”
The trusted third party responsible for certifying the non-viable nature of the activity referred to in 3° of article L. 5424-25 may be, at the choice of the self-employed worker:-a chartered accounta…
The competent authority's assessment of the applicant's command of the French language results in a decision that may be appealed to the administrative court with territorial jurisdiction.
The register of hybrid groups shows the proprietary medicinal products included in each hybrid group. The hybrid groups are grouped by active substance designated by its common name preceded by the wo…
1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du méd…
The purpose of the compassionate prescribing framework referred to in Article L. 5121-12-1 is to ensure the safety of prescribing a medicinal product which does not comply with its marketing authorisa…
I. - If required for public health reasons, in the event of a breach of the obligation to monitor patients and collect information, or if the conditions set out in Article L. 5121-12-1 are no longer m…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse authorisation for compassionate access if the conditions laid down in I, II and V of Articl…
Any measures taken by the holder of the exploitation rights to disseminate any information relating to the compassionate access authorisation from which it benefits to the healthcare professionals con…
Any measures taken by the marketing authorisation holder or the company operating the marketing authorisation to disseminate the compassionate prescribing framework or any information relating to this…
I.-When a medicinal product, which is the subject of a compassionate access authorisation, obtains a marketing authorisation, the Director General of the Agence nationale de sécurité du médicament et…
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