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Showing 31–40 of 43 articles for “Art. 1124”
An accelerated assessment procedure may be set up under conditions defined by order of the Minister for Health when the clinical trial of medicinal products takes place in the context of an emergency…
Applications for substantial amendments are subject to a simplified assessment procedure. These applications are examined by a select committee made up of two representatives from each of the colleges…
When the research concerns a medicinal product composed in whole or in part of genetically modified organisms, the provisions of articles R. 532-35 to R. 532-44 and R. 533-21 of the Environment Code a…
After submission of the application for clinical trial assessment defined in Article 5(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2004, a Data Protecti…
…the research mentioned in 1° or 2° of article L. 1121-1 or a clinical trial mentioned in article L. 1124-1 of the Public Health Code without having obtained the free, informed and, where applicable, w…
…Title II of Book I of Part One of this Code, including the clinical trials mentioned in article L. 1124-1, ensure that the provisions of article L. 513-11-4 are complied with. For the importation of…
…eir work;12° The authorisation of the competent authority provided for in articles L. 1123-8 and L. 1124-1;13° Where applicable, the batch/serial number or unique code, and where applicable the expiry…
…competent to give an opinion on the requests for opinions provided for by articles L. 1123-6 and L. 1124-1 as well as 2° and 3° of article R. 1123-21. The date of the draw confers a definite date on t…
…rson mentioned in 1° or 2° of Article L. 1121-1, including a clinical trial mentioned in Article L. 1124-1, in progress for commercial purposes in the indication concerned, it shall request an underta…
…of article L. 1121-1 for commercial purposes, including the clinical trial mentioned in article L. 1124-1, in progress, for the medicinal product concerned;6° The prescriber's undertaking that his ap…
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