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Showing 1641–1650 of 6855 articles for “Art. EU Regulation 2016/1103”
…h petrol or superethanol E85 and those that combine petrol with natural gas fuel or liquefied petroleum gas whose emissions are less than or equal to a value set by decree, which fall into one of the…
…ng him. The information shall be communicated in accordance with paragraphs 2 to 6 of Article 63 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017. Where the cl…
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…
I.-For the duration of the clinical investigation involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints whi…
…e Data Protection Committee. The Committee will issue a reasoned opinion within a time limit set by regulation. In the event that the Committee is at fault in the performance of its duties, the State…
…rd paragraph of article L. 1125-9 shall be punished by one year's imprisonment and a fine of 15,000 euros.
…categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.
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…
I.-Natural persons guilty of the offence referred to in article L. 1125-21 shall also be liable to the following penalties: 1° disqualification from civic, civil and family rights, in accordance with…
The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the…
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