Subsection 1: Application for early access authorisation

I.-The application for authorisation to obtain the early access provided for in Article L. 5121-12 is sent by electronic means, by the holder of the exploitation rights or his authorised representative, simultaneously to the Haute Autorité de Santé and to the Ministers for Health and Social Security and, where the application concerns a medicinal product mentioned in 1° of II of the aforementioned Article, to the Agence nationale de sécurité…

When the application for early access authorisation concerns a medicinal product composed, in whole or in part, of genetically modified organisms, the holder of the exploitation rights, or his authorised representative, sends the Agence nationale de sécurité du médicament et des produits de santé an application for authorisation to market the genetically modified organism underArticle L. 533-5 of the Environment Code. The provisions of article R. 533-49 of the same…