French Public Health Code
In forceI.-For each of the indications for which an application for early access authorisation has been submitted as mentioned in article R. 5121-68, the Haute Autorité de santé will inform the applicant of its reasoned decision within three months of acknowledgement of receipt of the complete dossier.
II. - When it concerns a medicinal product mentioned in 1° of II of Article L. 5121-12, the authorisation decision is taken after receiving the assent of the Agence nationale de sécurité du médicament et des produits de santé, attesting to the strong presumption of efficacy and safety of the medicinal product in each indication considered. This opinion is accompanied by the summary of product characteristics, the labelling and the package leaflet, drawn up by the Agency on the basis of the drafts mentioned in article R. 5121-68.
If the Haute Autorité de santé's authorisation decision includes a restriction, with regard to the criteria referred to in I of article L. 5121-12 other than efficacy and safety, of the scope of the indications covered by the authorisation in relation to the indications mentioned in the Agency's assent, this decision is sent to the Agency without delay with a view to adapting the summary of product characteristics, labelling and package leaflet.
The summary of product characteristics, labelling and package leaflet drawn up by the Agency are sent to the applicant by the Haute Autorité de santé as part of the communication referred to in I.
In the event of an unfavourable opinion from the Agence nationale de sécurité du médicament et des produits de santé on the presumed efficacy and safety of the medicinal product, the Haute Autorité de santé will refuse authorisation for early access.
III. - When the number of applications is exceptionally high, the time limit mentioned in I is extended by one month. This information is communicated to the applicant.
IV. - For medicinal products authorised in application of 1° of II of Article L. 5121-12, the Agence nationale de sécurité du médicament et des produits de santé assigns to the medicinal product the national number identifying the presentation of the medicinal product referred to in Article R. 5121-4 under the conditions laid down in the order provided for in this Article.
V. - A.- If, at the end of the period referred to in I, the Haute Autorité de Santé remains silent on an application for authorisation for a medicinal product referred to in 1° of II of Article L. 5121-12, this will be deemed to constitute a decision of acceptance if the opinion of the Agence nationale de sécurité du médicament issued within the same period attests to the strong presumption of efficacy and safety of the medicinal product in each indication considered. In the absence of a favourable opinion from the Agence nationale de sécurité du médicament et des produits de santé, the application is deemed to have been rejected.
B.- If the Haute Autorité de santé does not respond within the same time limit to an application for authorisation for a medicinal product mentioned in 2° of II of Article L. 5121-12, this will be deemed to constitute a decision of acceptance.
