The establishment or authorised body must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé a copy of any instrument appointing the responsible person referred to in Article R. 4211-37 and the interim responsible person or persons.
When the responsible person or the acting responsible person is temporarily or permanently replaced, the authorised establishment or body immediately informs the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the name and date of commencement of duties of the designated responsible person.