Article L1126-3
…t et des produits de santé. In the event of an unfavourable opinion from the committee, the sponsor may request that its proposed substantial amendment be submitted for a second examination to another…
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Showing 3781–3790 of 33006 articles for “Art. CJEU – C-48/16 – 17 May 2017”
…t et des produits de santé. In the event of an unfavourable opinion from the committee, the sponsor may request that its proposed substantial amendment be submitted for a second examination to another…
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.
Performance studies may only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the per…
No performance study may be carried out on a deceased person in a state of brain death without his or her consent expressed during his or her lifetime or through the testimony of his or her family. Ho…
…n the event of a refusal of validation provided for in paragraph 3 of Article 66 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Arti…
Failure to comply with Article 73(1) and Article 76(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on the communication of information intended to be made…
I.-The performance reviews of the devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 shall be governed by the provisions of the…
Any professional who markets maintenance and repair services for household electrical equipment, small IT and telecommunications equipment, screens and monitors shall include at least one offer, for c…
…cy care and accommodation. The annual amount of expenditure giving entitlement to the tax reduction may not exceed €10,000 per person accommodated.
The authorisation holder must ensure, in the context of exposure to ionising radiation, that staff and patients have access to the tools needed to optimise radiation protection. A dedicated echocardio…
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