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Showing 211–220 of 14565 articles for “Art. L112-6”
No one may carry out any research mentioned in 1° of Article L. 1121-1 without authorisation from the competent authority issued within a period set by regulation.If the competent authority informs th…
If a person likely to assist in a research project mentioned in 1° or 2° of article L. 1121-1 falls into more than one of the categories mentioned in articles L. 1121-5 to L. 1121-8, those of these pr…
Clinical investigations may only be carried out in a place that has the human, material and technical resources appropriate to the clinical investigation and compatible with the safety requirements of…
Research may only be carried out in a place that has the human, material and technical resources appropriate to the research and compatible with the safety requirements of the persons undergoing the r…
The competent authority may, at any time, ask the sponsor for additional information about the research. If there is a risk to public health or if the sponsor fails to respond, or if the competent aut…
Any promoter whose civil liability is not covered by the insurance provided for in the third paragraph of article L. 1125-9 shall be punished by one year's imprisonment and a fine of 15,000 euros.
Where a clinical investigation is carried out at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to communicate…
Pregnant women, women in labour and breast-feeding mothers may only be asked to take part in the research mentioned in 1° or 2° of Article L. 1121-1 under the following conditions:-either the importan…
If the research is to be carried out in one or more public or private establishments, the sponsor must inform the director(s) of these establishments before the research is carried out.
The clinical investigation does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applica…
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