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Showing 211–220 of 43820 articles for “Art. L112-2”
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…
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 (…
Pursuant to Articles 58,66 and 70 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the proje…
Any promoter whose civil liability is not covered by the insurance provided for in article L. 1126-8 shall be punished by one year's imprisonment and a fine of 15,000 euros.
When the National Agency for the Safety of Medicines and Health Products, the High Authority for Health, the Minister for Health or the European Medicines Agency refers a non-interventional research p…
The sponsor may ask the person undergoing research to give informed consent at the time when he or she is required to agree to his or her data being used in subsequent research exclusively for scienti…
Articles L. 1121-4 and L. 1121-15 do not apply to non-interventional research involving cosmetic or food products where such research is included in a list established by order of the Minister for Hea…
A concession contract for works and services is a works concession if its main purpose is to carry out works.
The purpose of a service concession contract is to manage a service. It may involve awarding a concession to manage a public service. The concessionaire may be responsible for building a facility or a…
Legal entities declared criminally liable, under the conditions set out in article 121-2 of the French Penal Code, for the offence defined in article L. 1128-3 shall incur, in addition to the fine set…
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