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Showing 7291–7300 of 24518 articles for “Art. CA Reims – 4 Oct. 2010”
I.-The early access authorisation may 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 h…
…121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing auth…
…request of the Minister for Health, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and ti…
…referred to in article R. 5121-76-3 and the scientific knowledge available, as well as, where applicable, the information transmitted in application of article R. 5121-76-2, the Agence nationale de s…
…of this authorisation addressed to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. This request is accompanied by any clinical data of which the presc…
…city, identify and provide proof of unlawful handling of the medicinal product. This replacement is carried out without opening the immediate packaging as defined in 3° of article R. 5121-1 and in com…
The pharmacovigilance carried out on individually prepared advanced therapy medicinal products includes monitoring to ensure traceability between the various stages, from the removal of tissues, cells…
When the companies and organisations mentioned in article R. 5124-2 become aware of the falsification or suspected falsification of medicinal products which they manufacture, operate or distribute, wh…
The dispensing pharmacist may inform the operator, in particular via the emergency call centres or any equivalent system mentioned in article R. 5124-49-1, of supply shortages of the medicinal product…
An order by the Minister for Vocational Training specifies the data mentioned in article R. 6113-17-1 and the procedures for transmitting it to the personal training account information system.
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