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Article R1123-54 of the French Public Health Code

November 6, 2023

For the research mentioned in 1° of Article L. 1121-1 involving the cell therapy preparations defined in Article L. 1243-1, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reactions occurring in France and outside national territory within the following time limits: 1° In the case of a serious unexpected adverse reaction resulting in death or life-threatening…

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Article R1123-55 of the French Public Health Code

November 6, 2023

For the research referred to in 1° of Article L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reaction and any serious adverse event that may be related to the procedure for using the medical device that occurs in France and outside national territory: 1° In…

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Article R1123-56 of the French Public Health Code

November 6, 2023

For the research mentioned in 1° of Article L. 1121-1 concerning cosmetic products or tattooing products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspicion of a serious adverse reaction occurring in France and outside national territory. The notification must be made without delay and at the latest within seven days of the day on which it came to the…

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Article R1123-57 of the French Public Health Code

November 6, 2023

For the research mentioned in 1° of Article L. 1121-1 involving the products mentioned in I of Article R. 1211-29 with the exception of cell therapy preparations, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any serious adverse reaction and any serious incident occurring in France and outside national territory in the research it is conducting, without delay from the day…

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Article R1123-58 of the French Public Health Code

November 6, 2023

For the research referred to in 1° of Article L. 1121-1 involving labile blood products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any adverse reaction occurring in a person undergoing such research and any serious incident occurring in France and outside national territory without delay from the day on which he becomes aware of them. Relevant additional information concerning the…

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Article R1123-59 of the French Public Health Code

November 6, 2023

The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the measures taken. The sponsor shall inform the Director General of the Regional Health Agency without delay of any new facts involving persons with no medical condition who voluntarily lend themselves to research and, where appropriate, of the…

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Article R1123-60 of the French Public Health Code

November 6, 2023

The form, content and procedures for reporting adverse reactions and new facts as defined in Article L. 1123-10 and, where applicable, the procedures for lifting the blind shall be laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) for research falling within its remit.

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Article R1123-61 of the French Public Health Code

November 6, 2023

Once a year for the duration of the research referred to in 1° of Article L. 1121-1 or on request, the sponsor must send the competent authority defined in Article L. 1123-12 and the relevant Data Protection Committee a safety report taking into account all available safety information. This report, the reporting procedures, form and content of which are specified by order of the Minister for Health, issued on a…

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Article R1123-62 of the French Public Health Code

November 6, 2023

Urgent safety measures taken in accordance with the fourth paragraph of Article L. 1123-10, consisting of stopping the research or taking immediate measures, are followed, depending on the case, either by a declaration concerning the end of the research or by an application for substantial modification. Applications for an opinion and, where applicable, for authorisation of substantial modifications are submitted, within fifteen days of the introduction of urgent safety measures,…

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Article R1123-63 of the French Public Health Code

November 6, 2023

If the competent authority defined in article L. 1123-12 considers that the sponsor, the investigator or any other person involved in the conduct of the research is no longer fulfilling its obligations, it shall send the sponsor or any person in charge of the research a formal notice prescribing the corrective measures to be taken, together with a deadline. The formal notice is forwarded without delay by the sponsor to…

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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396

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75001, Paris France
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Paris Bar Registration n° (Toque) C2396

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