Article R4314-6
The use of an assumed identity is permitted when the market surveillance authority or the regulated agent has information enabling it to consider that its identification would be likely to hinder the…
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Showing 5221–5230 of 21542 articles for “Art. Cass. com. 24 March 2021”
The use of an assumed identity is permitted when the market surveillance authority or the regulated agent has information enabling it to consider that its identification would be likely to hinder the…
If, during an inspection, the Minister for Health finds that the compensation paid exceeds the net costs incurred in providing the service of general economic interest, he will require the party respo…
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 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…
…ed in article 10.2.4 of the World Anti-Doping Code in the version that came into force on 1 January 2021.II - When the breach of article L. 232-9 or 2° of article L. 232-10 involves a substance of abu…
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