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Showing 8811–8820 of 24302 articles for “Art. IV”
…ct and supervise the performance of clinical trials are called investigators. Depending on their activity, investigators and investigators have the qualifications and experience mentioned in article R…
…tors within the meaning of Article R. 5141-3 with the following information: 1° The title and objective of the trial requested ; 2° Identification of the medicinal product to be tested: a) Its name or…
…information: 1° The identity of the sponsor ; 2° The framework of the trial: a) The title and objective of the trial ; b) The site or sites of the trial; c) The identity of the investigator(s), their…
…investigators conducting the clinical trials with the following information: 1° The title and objective of the trial requested; 2° For the medicinal product to be tested : a) Its name or code name ; b…
Without prejudice to the information required by the legislative and regulatory provisions relating to poisonous substances, the labelling of the immediate packaging and the outer packaging of a veter…
…means any material whatever its origin, which may be : - human, such as human blood and products derived from human blood; - animal, such as micro-organisms, whole animals, parts of organs, animal sec…
Any substantial amendment to the trial must be the subject of a prior additional declaration by the sponsor sent by registered post with acknowledgement of receipt to the Director General of the Agenc…
The experimenters, investigators, experts and persons called upon to collaborate in the trials are bound by professional secrecy under the conditions and penalties laid down inarticle 226-13 of the Fr…
Medicinal products subject to clinical trials, on the one hand, and any reference medicinal products and placebos, on the other, are prepared in accordance with good manufacturing practice, defined in…
As stated in article R. 234-5 of the French Rural and Maritime Fishing Code, which reads as follows: "When a person who keeps animals belonging to one of the species whose flesh or products are intend…
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