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Showing 54515460 of 14512 articles for Art. CE 25-7-1986 n° 41921

French Public Health CodeIn force
Subsection 6: Publication of compassionate access authorisations

Article R5121-74-11

…he holder of the exploitation rights to disseminate any information relating to the compassionate access authorisation from which it benefits to the healthcare professionals concerned must not constit…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 2: Investigation, authorisation, refusal, renewal

Article R5121-74-1

I.- When examining any request for authorisation for compassionate access, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has the prerogatives set out…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Section 7b: Compassionate prescribing frameworks

Article R5121-76-11

…scribing framework or any information relating to this framework to the healthcare professionals concerned must not constitute advertising within the meaning of Article L. 5122-1. These measures are s…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Section 7b: Compassionate prescribing frameworks

Article R5121-76-4

…l as, where applicable, the information transmitted in application of article R. 5121-76-2, the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safe…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 3: Protocol for therapeutic use and patient monitoring

Article R5121-74-5

I.-The granting of a compassionate access authorisation is subject to the establishment by the Agence nationale de sécurité du médicament et des produits de santé of a therapeutic use and patient moni…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 5: Suspension, withdrawal and termination of compassionate access authorisation

Article R5121-74-9

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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 5: Suspension, withdrawal and termination of compassionate access authorisation

Article R5121-74-8

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or withdraw a compassionate access authorisation if the conditions laid down in I, II and V…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Section 7b: Compassionate prescribing frameworks

Article R5121-76-2

Any practice of prescribing a medicinal product outside the scope of its marketing authorisation may be reported by electronic means to the Director General of the Agency, to enable him to assess the…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 2: Investigation, authorisation, refusal, renewal

Article R5121-74-4

I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurit…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Section 7b: Compassionate prescribing frameworks

Article R5121-76-6

I. - Except when the Agence nationale de sécurité du médicament et des produits de santé makes use of the derogation mentioned in V of article L. 5121-12-1, the compassionate prescription framework is…

AI translation · Updated 2 Nov 2023Open Article
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