Section 10: Observatories for medicinal products, medical devices and therapeutic innovation

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R1413-90R1413-91

Article R1413-90

French Public Health CodeIn force
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Updated 4 Nov 2023

In each region, an observatory for medicinal products, medical devices and therapeutic innovation is responsible for the following:

1° Supporting the drafting of the contracts mentioned in article L. 162-30-2 of the Social Security Code and analysing the annual evaluation reports, relating to the contract for improving the quality and efficiency of care, in particular the proper use of medicines, products and services under the said contract. As part of this, the Observatory proposes and carries out any supporting action to improve results in relation to the objectives of the said contract;

2° Medico-economic expertise, as well as monitoring and analysing prescriptions, dispensing and use of medicines, products and services observed at regional level. Within this framework, the Observatory offers support to healthcare establishments, medico-social establishments and services and all healthcare professionals, regardless of where or how they practise, in order to improve the quality, safety and appropriateness of the use of medicines, products and services and contribute to the fight against iatrogenia. It provides healthcare structures and professionals with appropriate information, training and tools, without prejudice to the missions of the Agence nationale de sécurité du médicament et des produits de santé (National Agency for the Safety of Medicines and Health Products) referred to in Article L. 5311-1 and the missions of the regional pharmacovigilance centres referred to in Articles R. 5121-158 and R. 5121-159, with which it collaborates and organises regular exchanges on practices relating to the use of medicines, products and services, in particular those mentioned in Article L. 162-22-7 of the Social Security Code;

3° Participating in the work of the regional vigilance and support network, referred to in Article R. 1413-62, in its region, of which it is a member. At the request of the regional health agency, it contributes to the management of serious adverse events associated with healthcare, in support of the other member structures of the regional vigilance and support network, if defects in the use of medicines, products and services are at the root of these events or have contributed to them.

The Minister for Health may appoint one or more observatories to carry out studies and work in their respective areas of competence, after informing the Director(s) General of the Regional Health Agency(ies) concerned.

An inter-regional observatory may be set up for several regional health agencies in place of the regional observatories.

Mariela Petrova

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Mariela Petrova

Mariela Petrova

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Communications protected by professional secrecy — secret professionnel de l'avocat, Article 66-5 of the Law of 31 December 1971.

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