Subsection 2: Authorisation procedure

Any changes relating to :

1° The name or administrative address of the establishment or organisation, or where applicable the authorised site;

2° The appointment of a new director of the establishment or authorised body or, in the case of the Etablissement Français du Sang, the appointment of a director of a blood transfusion establishment;

3° The implementation of new technical equipment, including new medico-technical software used for the traceability of products linked to activities;

4° Third parties and the agreements entered into with these third parties referred to in 1° of II of article R. 1243-4 , provided that this modification has no impact on the product;

5° the appointment of a new responsible person as defined in the first paragraph of article R. 1243-12;

6° The appointment of a new person responsible for activities as defined in the last paragraph of article R. 1243-12.

7° The closure of the establishment or organisation and the site;

8° To the process and the product which are not substantial modifications and appear, as such, on a list established by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, published on the website of the Agence nationale de sécurité du médicament et des produits de santé.

The declaration is made no later than one month following the implementation of the aforementioned changes.

It must be sent by the legal entity holding the authorisation to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by any means that provides a date certain of receipt.

This request must be accompanied by a letter explaining the purpose and possible impact of the changes on the authorised activities. The Director General of the Agence nationale de sécurité du médicament et des produits de santé may ask the establishment or organisation for any additional information concerning the declaration.

When the establishment or organisation obtains an element or product derived from the human body mentioned in Article R. 1243-1 from a Member State of the European Union or party to the Agreement on the European Economic Area whose process has been authorised under Article 6.2 of Directive 2004/23/EC, it declares this to the Agence nationale de sécurité du médicament et des produits de santé under the same conditions.