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Showing 6641–6650 of 68891 articles for “Art. s. L 312-12 and R 312-2”
French Public Health CodeIn force
Section 4: Conditions for recognising the evidential value of documents containing personal health data created or reproduced in digital form and for destroying documents stored in a form other than digital
Article L1111-26
A digital copy of a document referred to in article L. 1111-25, which meets the conditions of reliability set out in the second paragraph of article 1379 of the Civil Code, has the same evidential val…
Section 4: Conditions for recognising the evidential value of documents containing personal health data created or reproduced in digital form and for destroying documents stored in a form other than digital
Article L1111-27
A document referred to in article L. 1111-25 of this code created in digital form has the same evidential value as a paper document when it has been drawn up and stored under the conditions set out in…
Section 4: Conditions for recognising the evidential value of documents containing personal health data created or reproduced in digital form and for destroying documents stored in a form other than digital
Article L1111-29
At the request of the persons directly concerned by these documents, the professionals, services, establishments and bodies referred to in article L. 1111-25 may create a document containing personal…
Chapter V: Specific provisions applicable to clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Article L1125-29
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 (…
Chapter V: Specific provisions applicable to clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Article L1125-24
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.
Chapter V: Specific provisions applicable to clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Article L1125-27
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…
Chapter V: Specific provisions applicable to clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Article L1125-25
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulti…
Chapter V: Specific provisions applicable to clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Article L1125-26
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
Chapter V: Specific provisions applicable to clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Article L1125-20
The competent authority may, at any time, request additional information on the clinical investigation from the sponsor. Where the competent authority considers that the requirements set out in Regula…
Chapter V: Specific provisions applicable to clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Article L1125-28
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
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Mariela Petrova
Avocate au Barreau de Paris
Toque #C2396
15+ Years In French Corporate Practice
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