Subsection 2: Provisions relating to the import of products from Member States of the European Union or parties to the European Economic Area not authorised in their country of origin

I. – The application for authorisation provided for in the second paragraph of I of Article L. 1245-5 for products from Member States of the European Union or parties to the Agreement on the European Economic Area that do not have the authorisation provided for in Article 6(2) of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human…

I. – The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within three months of the date on which the application is deemed to be complete. II. – He may request any additional information he considers necessary, by any means capable of providing a definite date for this request. In this case, the time limit stipulated…