Section 1: Authorisation to manufacture, import and distribute active substances.

I. – The application for authorisation provided for in Article L. 5138-1 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by the legal representatives of the establishment by any means that enables receipt to be acknowledged, at least sixty days before the planned date of commencement of the activity. II. – It includes the following information : 1° Administrative information relating to…

The information mentioned in 1° to 3° of article R. 5138-1, with the exception of the name of the establishment’s legal representatives, is entered in the European Union database.