Subsection 2: Vigilance relating to health products

Articles in this section · 6

R1413-61-1R1413-61-2R1413-61-3R1413-61-4R1413-61-5R1413-61-6

Article R1413-61-4

French Public Health CodeIn force
Ask for lawyer reviewed or certified translation

Updated 4 Nov 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 out the necessary investigations;

2° Alerting the Director General of the Agence nationale de sécurité du médicament et des produits de santé in the event of serious adverse reactions or a threat to public health;

3° Coordinating and leading networks of healthcare professionals and, where appropriate, local vigilance correspondents within the region;

4° Providing expertise and support to regional health agencies, local vigilance correspondents and healthcare professionals wherever and however they practise, to improve the quality and safety of healthcare, without prejudice to the missions of the Agence nationale de sécurité du médicament et des produits de santé relating to the safety of healthcare products;

5° Provide expertise, by carrying out studies and work requested of them by the Minister for Health or the Director General of the National Agency for the Safety of Medicines and Health Products, in particular for the assessment of information resulting from the alerts mentioned in 1°, the alerts mentioned in 2° and the risks relating to health products and other products, substances or plants with psychoactive effects or for the development of knowledge on vigilance methods.

II.An order from the Minister for Health specifies for each centre or coordinator mentioned in I:

1° Its missions and the procedures for implementing them at the request of regional health agencies and the Agence nationale de sécurité du médicament et des produits de santé;

2° The procedures for appointing centre managers and coordinators;

3° The conditions for funding these missions.

Mariela Petrova

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Mariela Petrova

Mariela Petrova

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