Article R5132-42 of the French Public Health Code
The procedures for applying sections 1 to 3 of this chapter to the establishments mentioned in articles L. 5126-1 and L. 5126-11 shall be laid down, where appropriate, after obtaining the opinion of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health.