Section 1a: Declaration of the manufacture, import and distribution of excipients

The declaration provided for in Article L. 5138-1 is sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised to bind the company to which the establishment belongs, by any means enabling receipt to be acknowledged. It includes the following information: 1° The name or corporate name and address of the company to which the establishment belongs and the address of the…

The descriptive file provided for in Article L. 5138-1 and accompanying the declaration shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of acknowledging receipt. It includes the following information 1° Administrative information relating to the establishment where the activity of manufacturing, importing or distributing excipients is carried out, its internal organisation and, where applicable, its other activities and…