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Part One: General health protection

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Article D1413-56 of the French Public Health Code

November 5, 2023

The Minister for Health and the Director General of the National Public Health Agency must be informed without delay of any change in the conditions under which the national reference centre carries out its activities as set out in the specifications. If a national reference centre wishes to cease carrying out its missions, it must inform the Minister for Health and the Director General of the National Public Health Agency…

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Article D1413-57 of the French Public Health Code

November 5, 2023

All the tasks provided for in article D. 1413-46 are funded by an annual grant paid by the Agence nationale de santé publique, within the limits of the appropriations entered in its budget. The payment of this grant is subject to the submission of the report and the financial use account required to evaluate the annual amount of this grant, mentioned in 3° of article D. 1413-47. If necessary, these…

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Article D1413-58 of the French Public Health Code

November 5, 2023

I.-A website, developed and implemented by the consortium mentioned in article L. 1111-24, is made available to the public, healthcare professionals and professionals in the health and medico-social sectors to facilitate, promote and collect the declaration or reporting of undesirable health events appearing on a list drawn up by the Minister for Health. This website enables declarations or reports to be transmitted to the authorities and establishments responsible for processing…

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Article R1413-58-1 of the French Public Health Code

November 5, 2023

I. – An information system called “LABOé-SI” is hereby created, implemented under the responsibility of the Directorate-General for Health, the purpose of which is to contribute to epidemiological surveillance and health monitoring. This processing is implemented as part of a mission of public interest in accordance with the provisions of e of 1. of Article 6 of Regulation (EU) 2016/679 of 27 April 2016 and for the reasons of public…

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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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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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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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