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Showing 211220 of 1215 articles for Art. s. 1123

French Public Health CodeIn force
APPENDICES TO PART ONE

Article Annexe 11-2 (suite 1)

…replacement by a mobile prosthesis and by two-thirds in the case of replacement by a fixed prosthesis.In the event of complete loss of a tooth replaced by an implant-supported prosthesis: 0%.Pulpal mo…

AI translation · Updated 30 Oct 2023Open Article
French Public Health CodeIn force
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 L1125-1

…78 and 82 of this Regulation is the National Agency for the Safety of Medicines and Health Products. A scientific examination is required for the following clinical investigations:pursuant to articl…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Subsection 4: Notification procedure.

Article R1123-20

…nvolving the human person is filed by the sponsor on the information system mentioned in article R. 1123-20-1, which assigns it to a personal data protection committee under the conditions provided fo…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Section 10: Import and export

Article R5121-108

…ng the human person which has been the subject of an authorisation within the meaning of Article L. 1123-8 is subject, prior to its importation into the customs territory, to an import authorisation i…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 1: Vigilance.

Article R1123-55

…to the action of implementing the medical device, as well as the new facts mentioned in Article L. 1123-10, the relevant additional information is sent to the Agence nationale de sécurité du médicame…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

Article L1126-1

…Council of 5 April 2017 shall be the National Agency for the Safety of Medicines and Health Products. A scientific review is required, pursuant to point b of paragraph 7 of Article 66 of the aforemen…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter IV: Manufacturing and wholesale distribution.

Article L5124-13

…isations within the meaning of the previous paragraph. The authorisation provided for in article L. 1123-8 is equivalent to an import authorisation for any medicinal product required to carry out the…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Single chapter.

Article L1211-2

…ned, or if one of the advisory committees for the protection of individuals mentioned in article L. 1123-1, consulted by the person responsible for the research, does not consider this information to…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter I: General principles relating to research involving the human person

Article L1121-16-1

…uthorisation from the competent authority, in accordance with the procedures set out in articles L. 1123-7 and L. 1123-12, when they are not used under conditions giving entitlement to reimbursement,…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Section 1: Scope and definitions

Article R5124-3-1

…L. 1121-1 may exceptionally make investigational medicinal products available to other investigators. It is mentioned in the elements of the protocol provided for in article R. 1123-20 and is carried…

AI translation · Updated 2 Nov 2023Open Article
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