Article R5121-9-2
…orresponding reference medicinal product, by means of a decision, which may include recommendations and warnings, and which he notifies to the holder of the marketing authorisation granted for this si…
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Showing 3291–3300 of 58313 articles for “Art. n° 09-069 and 9 September 2020”
…orresponding reference medicinal product, by means of a decision, which may include recommendations and warnings, and which he notifies to the holder of the marketing authorisation granted for this si…
…ter of hybrid groups indicates, for each medicinal product, its name, strength, pharmaceutical form and the name of the marketing authorisation holder and, if different from the marketing authorisatio…
…products. For the purposes of application of these provisions, the Ministers responsible for health and social security, at the request of an applicant, may refer a request to the Director of the Agen…
…de a medicinal product on the reference list of similar biological groups, to amend these decisions and to remove it from this list are published on the website of the Agence nationale de sécurité du…
…ationale de sécurité du médicament et des produits de santé by the ministers responsible for health and social security, on the order mentioned in the last paragraph of II of Article L. 5125-23, speci…
With a view to their inclusion in the register of hybrid groups mentioned in the last paragraph of Article L. 5121-10, hybrid medicinal products are identified by a decision of the Director General of…
…d for each reference biological medicinal product for which the name, strength, pharmaceutical form and common name of the active substance it contains are indicated. This list includes the medicinal…
…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 met, the…
…ployee in the live performance or recorded performance sectors must provide evidence of two hundred and eighty days' work or fees spread over the last two to five years and meet one of the following s…
The joint national information system of the cross-industry joint committees enables the data referred to in II of article R. 6323-34 that it holds to be transmitted to the information system for the…
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