Subsection 6: Publicising and monitoring early access authorisations

Articles in this section · 2

R5121-73R5121-73-1

Article R5121-73

French Public Health CodeIn force
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Updated 2 Nov 2023

I.-The Haute Autorité de santé makes public, on its website, all decisions concerning authorisation, refusal, withdrawal, suspension, renewal and modification of early access, summaries of the summary reports mentioned in Article R. 5121-70-1 and any annexes thereto under the conditions mentioned in the present section, and information concerning the submission of the full application mentioned in Article R. 5121-68. The website of the Haute Autorité de santé provides access to the summary of product characteristics, the labelling and the package leaflet mentioned in Article R. 5121-69, published on the website of the Agence nationale de sécurité du médicament et des produits de santé.

II.-The Agence nationale de sécurité du médicament et des produits de santé makes public, on the Agency's website, for the medicinal products mentioned in 1° of II of Article L. 5121-12:

1° Therapeutic use and data collection protocols;

2° Summaries of the summary reports mentioned in Article R. 5121-70-1;

3° All opinions issued by the Agence nationale de sécurité du médicament et des produits de santé relating to early access in application of this section;

4° the latest version drawn up by the Agency of the summaries of product characteristics, package leaflets and labelling;

5° the reasoned decisions to suspend an early access authorisation when this occurs in the case mentioned in the last paragraph of Article L. 5121-12.

The information mentioned in 1°, 2° and 3° is made public as soon as the publication mentioned in I has been made or at the latest at the end of the three-month period mentioned in I of Article R. 5121-69, where applicable extended in accordance with the same I or suspended pursuant to IV of Article R. 5121-68 or Article R. 5121-69-1. The information mentioned in 4° is made public without delay.

III.-The ministers responsible for health and social security make public, on the website of the Ministry of Solidarity and Health, the list of medicinal products covered by an early access authorisation mentioned in article L. 5121-12 and the medicinal products for which this authorisation has ended, been suspended, withdrawn or modified.

IV -The Ministers responsible for Health and Social Security, together with the Haute Autorité de Santé and the Agence nationale de sécurité du médicament et des produits de santé, will draw up standard model forms, in particular those for applications for the early access authorisation referred to in article L. 5121-12, the application for renewal of the early access authorisation and the protocol for therapeutic use and data collection, as well as the summary report and its summaries. These models are made public by the Haute Autorité de Santé.

Mariela Petrova

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Any time a strategic decision changes how the company is owned, governed or contractually bound — incorporation, fundraising, M&A, restructuring, shareholder agreements, or major commercial contracts. Earlier engagement always costs less than later remediation.

A notary (notaire) is a public officer who authenticates specific deeds (mainly real-estate transfers and certain family-law acts). A corporate lawyer (avocat) advises on strategy, negotiates and drafts company documents, and represents you in disputes. The two roles complement rather than overlap.

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Mariela Petrova

Mariela Petrova

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15+ Years In Corporate Practice

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