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Showing 10781–10790 of 36632 articles for “Art. al. 5”
…benefit balance of the medicinal product or product as defined in the first paragraph of Article L. 5121-9. It shall forward the results of all studies, in particular safety and efficacy studies, and…
…ghts, the Haute Autorité de santé may modify any early access authorisation mentioned in article L. 5121-12 or the therapeutic use and data collection protocol. Where applicable, this decision is take…
In order to obtain recognition, by at least one other Member State of the European Community or party to the Agreement on the European Economic Area, of a marketing authorisation granted by the Direct…
…ot exceeding one year, or withdraw a marketing authorisation on the grounds mentioned in Article L. 5121-9. However, where the authorisation is suspended, either as a precautionary measure pending the…
When an application for authorisation concerns a generic medicinal product of a reference medicinal product which has not been authorised in France, the applicant must indicate the Member State of the…
A generic medicinal product or a medicinal product belonging to a generic group without a reference medicinal product, whose marketing authorisation is withdrawn, is removed from the register of gener…
The State representative checks that the declaration of candidacy is in order, pursuant to articles D. 4443-23 and D. 4443-24. He checks that the candidates meet the conditions defined in article D. 4…
Subject to the provisions of articles L. 1123-6 to L. 1123-8 and L. 1123-13 and those adopted for their application, the investigators and persons called upon to collaborate in the trials are bound by…
The reference list of similar biological groups provided for in article L. 5121-10-2 is presented for each reference biological medicinal product for which the name, strength, pharmaceutical form and…
The members of the Disciplinary Chambers of the Order of Pharmacists in New Caledonia and French Polynesia are elected by a one-ballot majority multi-mandate system. Each elector votes for as many can…
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