Chapter I: General provisions.

I.- By way of derogation from 1° and 4° of Article L. 4211-1, in the context of the research defined in Article L. 1121-1 , advanced therapy medicinal products mentioned in 17° of Article L. 5121-1 may be prepared, stored, distributed, transferred, imported and exported by establishments or organisations, including health establishments, authorised by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for…

By way of derogation from 1° and 4° of Article L. 4211-1 and in the context of the research referred to in the first paragraph of Article L. 1121-1, the manufacture, import, export, distribution and use of advanced therapy medicinal products defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive…

The person responsible for the activities referred to in Articles L. 4211-8 and L. 4211-9 must be a pharmacist, a doctor or a person authorised to practise as a doctor or pharmacist, or a person with appropriate scientific training. These persons must have specific qualifications and work experience in the fields of activity relating to gene therapy preparations and xenogenic cell therapy preparations, as well as skills acquired in these…

The provisions of articles L. 4211-8, L. 4211-9 and L. 4211-10 apply to army hospitals. A decree of the Conseil d’Etat determines the adaptations that may be made, with regard to these hospitals, to the authorisation procedures applicable to health establishments.