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Showing 371–380 of 60182 articles for “Art. I · Art. L 227-9”
I.- By way of derogation from 1° and 4° of Article L. 4211-1, in the context of the research defined in Article L. 1121-1 , advanced therapy medicinal products mentioned in 17° of Article L. 5121-1 ma…
By way of derogation from 1° and 4° of Article L. 4211-1 and in the context of the research referred to in the first paragraph of Article L. 1121-1, the manufacture, import, export, distribution and u…
The holder of a marketing authorisation for a medicinal product shall immediately inform the Agence nationale de sécurité du médicament et des produits de santé, specifying the reasons, of any action…
In order to be able to continuously assess the benefit/risk balance of the medicinal product as defined in the first paragraph of Article L. 5121-9, the Agence nationale de sécurité du médicament et d…
The company or organisation exploiting a medicinal product or health product shall immediately notify the National Agency for the Safety of Medicines and Health Products of any prohibition or restrict…
Where a medicinal product is authorised in another Member State of the European Union or a State party to the Agreement on the European Economic Area, but is not the subject in France of either the ma…
As part of its remit, the risk committee shall examine whether the prices of the products and services referred to in books II and III offered to customers are compatible with the risk strategy of the…
In the performance of their duties, authorised agents may record infringements and breaches of Chapters I and III of Title I, and Chapters I, II, III, and IV of Title II of the loi n° 78-17 du 6 janvi…
A seller who has stipulated at the time of the sale that, in the absence of payment within the agreed term, the sale will be cancelled ipso jure, or who has obtained amicable cancellation from the pur…
Advertising of a medicinal product to members of the health professions authorised to prescribe or dispense medicinal products or to use them in the exercise of their profession is subject to prior au…
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