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Section 4: Health monitoring and safety

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Article R1413-59 of the French Public Health Code

November 5, 2023

The Director General of the Regional Health Agency shall organise, in conjunction with the persons and structures referred to in Article R. 1413-62 and the regional response units referred to in Article L. 1413-2, the collection and transmission to the Agency, and the shared processing : 1° Data relating to cases of disease reported under the conditions set out in articles R. 3113-2 and R. 3113-3 ; 2° Reports of…

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Article R1413-60 of the French Public Health Code

November 5, 2023

An agreement between the Director General of the Regional Health Agency and the Director General of the Nuclear Safety Authority referred to inArticle L. 592-1 of the Environmental Code, or his representative in the region, specifies how these institutions will work together in the field of radiation protection, in particular for the management of significant events likely to have an impact on human health.

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Article R1413-61 of the French Public Health Code

November 5, 2023

The Director General of the Regional Health Agency holds a regional health security meeting to ensure the exchange of information on current health events, to coordinate the processing of signals and to organise their management by ensuring, where appropriate, the implementation of corrective or preventive measures. In addition to the departments of the Regional Health Agency, this meeting brings together: 1° Representatives of the National Public Health Agency referred to…

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Article R1413-61-2 of the French Public Health Code

November 5, 2023

Vigilance missions relating to health products are carried out at national level by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), which oversees and coordinates these vigilance missions under the conditions set out in Article R. 5311-2.

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Article R1413-61-3 of the French Public Health Code

November 5, 2023

Vigilance missions relating to health products are carried out at regional level, by the regional pharmacovigilance centres, the centres for evaluation and information on pharmacodependence and addictovigilance, the regional haemovigilance and transfusion safety coordinators, and the regional materialovigilance and reactovigilance coordinators mentioned respectively in articles R. 5121-158, R. 5132-104, R. 1221-32 and R. 5212-7, and coordinated within the regional vigilance and support networks mentioned in article R. 1413-62. The centres…

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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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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396

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Linkedin

is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396

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