Article R5121-107-15
…data available to him, that, given its characteristics, the medicinal product is now covered by the marketing authorisation system or the registration system for homeopathic medicinal products, he sha…
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Showing 5951–5960 of 13025 articles for “Art. Euronext Harmonised Market Rules — derivatives”
…data available to him, that, given its characteristics, the medicinal product is now covered by the marketing authorisation system or the registration system for homeopathic medicinal products, he sha…
…in Article 107g(1) of Directive 2001/83/EC of the European Parliament and of the Council, that the marketing authorisation should be varied, the marketing authorisation holder shall submit to the Dir…
…rinary medicinal product, which has already been authorised or is the subject of an application for marketing authorisation under examination in another Member State of the European Union, is the subj…
Inclusion on the list defined in article L. 1121-15 of clinical trials prior to the granting of marketing authorisation is compulsory.
…ing an industrial process, as well as any generator, kit or precursor which is not the subject of a marketing authorisation issued by the European Union pursuant to Regulation (EC) No 726/2004 of the…
…rresponding reference proprietary medicinal product. This decision is notified to the holder of the marketing authorisation issued for these medicinal products. The Director General of the Agency will…
The marketing authorisation is renewable on application by the holder to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail no later…
…order to ensure the equality of holders of investment certificates or voting right certificates and market transparency, the General Regulations of the Autorité des marchés financiers determine : 1° T…
…ient computers, shall ensure: 1° From the date of placing the first unit of a model on the national market, the availability of the following spare parts for that model: a) Mass storage components (HD…
The application for marketing authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name and address of the f…
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