Article R5121-9-7
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…
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Showing 5411–5420 of 13866 articles for “Art. 25-7”
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…
Articles R. 5121-51 to R. 5121-51-4 are applicable to homeopathic medicinal products subject to the registration referred to in article L. 5121-13. This sub-section does not apply to homeopathic medic…
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…
The Agence nationale de sécurité du médicament et des produits de santé publishes on its website : 1° The initial compassionate prescribing framework, the protocol for therapeutic use and patient foll…
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…
On receipt of the opinion of the Agence nationale de sécurité du médicament et des produits de santé or on expiry of the period provided for in II of Article R. 5121-76-11, the Minister for Defence ma…
I.- Authorisation for compassionate access is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé for the duration of treatment of the patient in…
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…
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