Section 4: National tattoo product vigilance system.

For the purposes of this section, : “Misuse”: use that does not comply with the intended purpose of the product, its usual use or its instructions for use, or with the special precautions for use mentioned in 7° of article R. 513-10-5; Adverse reaction”: a noxious and unintended response occurring under normal conditions of use of a tattooing product or resulting from misuse of such a product; “Serious adverse reaction”:…

Tattoo products are subject to vigilance designed to monitor undesirable effects occurring under normal conditions of use of the product or resulting from misuse. This vigilance is applied to all these products once they have been placed on the market.

The national vigilance system comprises : 1° The Agence nationale de sécurité du médicament et des produits de santé ; 2° The competent administrative authorities designated in accordance with the procedures set out inArticle L. 221-1-3 of the French Consumer Code; 3° Health professionals; 4° The person responsible for placing a tattoo product on the market; 5° Persons who carry out tattooing on a professional basis; 6° Consumers of tattoo…

The vigilance exercised over tattooing products includes : 1° The immediate reporting of the serious adverse reactions mentioned in article L. 513-10-8, including those resulting from misuse, and the collection of information concerning them, as well as the collection of information mentioned in article R. 513-10-12 ; 1° bis The reporting of other adverse reactions, including those resulting from misuse of the product; 2° The recording, evaluation and use of…

The Agence nationale de sécurité du médicament et des produits de santé shall be responsible for implementing the national tattoo product vigilance system. It defines the guidelines, leads and coordinates the actions of the various parties involved and ensures compliance with the provisions of this section. It receives information sent to it by healthcare professionals, by people who carry out tattoos on a professional basis, by people responsible for placing…

In the event of a serious adverse reaction likely to be due to a tattooing product, the persons responsible for placing a tattooing product on the market, the health professionals who have observed it or the persons carrying out tattoos in a professional capacity who have knowledge of it shall report it without delay to the Director General of the Agence nationale de sécurité du médicament et des produits de…

When the Director General of the Agence nationale de sécurité du médicament et des produits de santé makes a reasoned request, the person responsible for placing the product on the market shall send him the information referred to in Article L. 513-10-9 without delay, specifying for each product: 1° Its commercial name ; 2° The name or company name and address of the person responsible for placing a tattoo product…

Persons who have access to the information referred to in article R. 513-10-12 are bound by professional secrecy under the conditions set out inarticle 226-13 of the French Criminal Code.