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Showing 6771–6780 of 43956 articles for “Art. L. 145-5”
In the context of a performance study involving an intervention not justified by the usual management of the participant and entailing risks and constraints that are not minimal, failure by the sponso…
…by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article 60 of Regulation (EU) 2017/7…
…this case, the foreseeable risk and the constraints involved in the performance study must be minimal.
The provisions of Section 3 of Chapter III of Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (…
Before a performance study is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this inform…
I.-Natural persons guilty of the offence referred to in article L. 1126-20 shall also be liable to the following penalties: 1° Disqualification from civic, civil and family rights, in accordance with…
…aving the necessary competence to examine the project, under the conditions provided for in Article L. 1123-14 or Article L. 1123-16. It may only request one opinion per performance study project. In…
For each study of performance, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulatio…
…nd, in the case of performance studies mentioned in the second to fifth paragraphs of II of Article L. 1126-1, the authorisation of the competent authority; 2° Under conditions contrary to the provisi…
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