Subsection 2: Obligations of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products)

The Agence nationale de sécurité du médicament et des produits de santé is responsible for :

1° Assigning the code defined in a of 2° of Article R. 1245-31 to the establishments it authorises pursuant to Article L. 1243-2, the first and second paragraphs of II of Article L. 1245-5, the first paragraph of II of Article L. 1245-5-1, and Articles L. 4211-9-1, L. 4211-9-2, L. 5124-3 and L. 5124-9-1 ;

2° Ensuring the implementation, information and monitoring of the single European code, in particular by ensuring that the legal entities and natural persons mentioned respectively in Articles R. 1245-35 and R. 1245-36 allocate the single European code or the donation identification sequence in compliance with the provisions of the order and the decision on good practice mentioned in Article R. 1245-33;

3° Ensuring that traceability is put in place for the tissues and cells mentioned in the first paragraph of Article R. 1245-32 which are excluded from the application of the unique European code;

4° To update the European Union register of establishments authorised under Article L. 1243-2, the first and second paragraphs of II of Article L. 1245-5, the first paragraph of II of Article L. 1245-5-1, and Articles L. 4211-9-1, L. 4211-9-2, L. 5124-3 and L. 5124-9-1. This update is made within a maximum of ten working days of changes to authorisations, in particular when a new establishment is authorised, when the information mentioned in Annex VIII of Commission Directive 2015/565/EU of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of tissues and cells of human origin is modified, when the authorisation is withdrawn, suspended or in the event of cessation of activity within the meaning of Articles R. 1243-11, R. 1245-10, R. 4211-42 or R. 4211-57;

5° Alert the competent authorities of another Member State of the European Union when it discovers inaccurate information relating to that other Member State in the European Union register of establishments or when it observes a case of significant non-compliance with the provisions relating to the single European code concerning that other Member State;

6° Alert the European Commission and the other competent authorities when it considers that the register of tissue and cell products hosted by the European Commission needs updating.