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Showing 4601–4610 of 6566 articles for “Art. 31 March 2009”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé or the applicant for marketing authorisation may refer the matter to the European Medicines Agency with…
When a change in the classification mentioned in 1° of Article R. 5121-36 is authorised, on the basis of preclinical and clinical studies considered to be significant during the scientific evaluation…
When it is informed by the holder of a marketing authorisation for a medicinal product granted under 1°, 2° or 3° of article R. 5121-28, prior to the marketing of the medicinal product or speciality c…
Amendments to the terms of the registration decision and the registration dossier are submitted and examined under the conditions laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/…
The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescri…
The provisions of the second paragraph of article R. 5122-2 and those of articles R. 5122-2-1, R. 5122-5, R. 5122-6, R. 5122-7, R. 5122-9 and R. 5122-13 to R. 5122-16 are applicable to advertising for…
The applicant for marketing authorisation is responsible for the accuracy and sincerity of the information and data provided to the Agence nationale de sécurité sanitaire de l'alimentation, de l'envir…
Any manufacturer, importer or distributor of reagents is liable to a fine of the fifth class: 1° Placing a reagent on the market, whether free of charge or against payment, without having registered i…
For the application of the regulatory provisions of Book III to Saint-Barthélemy:1° In article R. 2311-5 :a) 2° is deleted;b) In 6°, the words: "the other technical standards drawn up by the European…
…application of the regulatory provisions of Book III in Saint-Pierre-et-Miquelon:1°° In article R. 2311-5 :a) 2° is deleted;b) In 5°, the words: "other technical standards drawn up by European standar…
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