French Public Health Code
In forceI.-Establishments or organisations that prepare or import investigational advanced therapy medicinal products prepared on an ad hoc basis ensure that all preparation operations are carried out in accordance with the information provided by the sponsor in the application for authorisation referred to in article L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé.
II.-The importing establishment or organisation ensures that the investigational advanced therapy medicinal products prepared on an ad hoc basis that it imports:
1° Have been subjected to standards of good manufacturing practice at least equivalent to those provided for in article L. 5121-5;
2° Have been manufactured by an authorised manufacturer or, where applicable, notified to the competent authorities of the State in which the manufacturer is located, and accepted by them for this purpose.
