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Article R1413-61-4 of the French Public Health Code

November 5, 2023

I.-The tasks of the centres and coordinators mentioned in Article R. 1413-61-3 consist of : 1° Collecting and processing, each in their own field of competence and expertise, alerts relating to each of the vigilance procedures for health products, with a view to forwarding them to the Agence nationale de sécurité du médicament et des produits de santé (French Agency for the Safety of Medicines and Health Products) and carrying…

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Article R1413-61-6 of the French Public Health Code

November 5, 2023

I.-The Director General of the Regional Health Agency organises vigilance missions relating to health products at regional level. To this end: 1° After obtaining the opinion of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, he shall designate one or more health establishments to house the centres and coordinators referred to in Article R. 1413-61-3 ; 2° He shall organise the pooling…

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Article R1413-62 of the French Public Health Code

November 5, 2023

In application of article L. 1435-12, the Director General of the Regional Health Agency shall set up and run a regional vigilance and support network comprising the persons and representatives of the structures mentioned in articles R. 1221-32, R. 1340-4, R. 1413-75, R. 1413-83, R. 1413-86, R. 1413-90, R. 5121-158, R. 5132-104 and R. 5212-7. It associates with the network any other structure responsible for improving the quality and safety…

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Article R1413-63 of the French Public Health Code

November 5, 2023

In the absence of a person or structure forming the regional vigilance and support network in a region, the Director General of the regional health agency will contact the equivalent person or structure in the region that is the capital of the defence and security zone or, failing that, in another region, and will invite them to join the regional vigilance and support network in their area of responsibility. It…

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Article R1413-65 of the French Public Health Code

November 5, 2023

The territorial collectivity of Saint-Pierre and Miquelon has a territorial vigilance and support network for the organisation and territorial coverage of health vigilance. In addition to the departments of the territorial health administration, it is made up of the persons or representatives of the structures mentioned in articles R. 1221-32, R. 1340-4, R. 5132-112 and R. 5121-158 and any other structure responsible for improving the quality and safety of health…

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Article R1413-66-1 of the French Public Health Code

November 5, 2023

An undesirable event associated with the care provided during investigations, treatments, cosmetic medical procedures or preventive actions is an event that is unexpected with regard to the patient’s state of health and pathology, and which has potentially harmful consequences.

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Article R1413-67 of the French Public Health Code

November 5, 2023

A serious undesirable event associated with care provided during investigations, treatments, cosmetic medical procedures or preventive actions is an unexpected event with regard to the person’s state of health and pathology, the consequences of which are death, life-threatening conditions or the probable occurrence of a permanent functional impairment, including a congenital anomaly or malformation.

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is a Registered Trademark of
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75001, Paris France
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is a Registered Trademark of
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75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396

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