Article R5121-41-5-2
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…
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Showing 4391–4400 of 6365 articles for “Art. 25 March 1998”
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…
…n the case of an urban community or a metropolis, under the conditions laid down in article L. 5211-25-1, with the consent of the deliberative body of the establishment. In the absence of an agreement…
…f III of Article L. 214-24. II. - Portfolio management companies are authorised by the Autorité des marchés financiers. In order to grant authorisation to a portfolio management company, the Autorité…
…stance agreement with France to combat tax fraud and evasion, benefit from a tax reduction equal to 25% of the amount of expenditure they actually incur in respect of both dependency care and accommod…
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