Subsection 6: Publicising and monitoring early access authorisations

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…

Any measures taken by the holder of the early access authorisation issued for a medicinal product covered by 1° of II of Article L. 5121-12 to disseminate the authorisation, or any information relating to this authorisation, to the healthcare professionals concerned, must not constitute advertising within the meaning of Article L. 5122-1. These measures are subject to the prior opinion of the Agence nationale de sécurité du médicament et des…