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Showing 10711–10720 of 36632 articles for “Art. al. 5”
…en established following a report from one of the organisations mentioned in 1° to 4° of article R. 5121-76-2, in a given therapeutic indication. The list of medicinal products covered by a compassion…
…the national number identifying the presentation of the medicinal product referred to in Article R. 5121-4. These particulars are notified by the Director General of the Agence nationale du médicament…
…sation is granted for a period of five years. It specifies the differences mentioned in articles R. 5121-117 to R. 5121-119 with the speciality that has obtained marketing authorisation in France. It…
Any medicinal product which does not have a marketing authorisation as referred to in Article L. 5121-8 or an early access authorisation as referred to in Article L. 5121-12 or a compassionate access…
Where, following the establishment of a new Community herbal monograph, the revision of an existing monograph or the revision of the list drawn up by the European Commission in application of Article…
Classification in the category of medicinal products for initial prescription in hospitals may only take place if the restrictions placed on the prescription of the medicinal product are justified by…
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.-A.-Early access authorisations granted under article L. 5121-12 are subject to compliance with a therapeutic use and data collection protocol defined by the Haute Autorité de santé. The protocol is…
At the end of the procedures provided for in this sub-section, the marketing authorisation is issued or varied by the Director General of the Agence nationale de sécurité du médicament et des produits…
The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package le…
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