Title III: Other regulated pharmaceutical products and substances

Tattoo products are rendered sterile using appropriate processes. They are supplied in a container which retains sterility until use. Multiple dose containers are authorised provided that the delivery of each dose does not compromise the sterility of the product remaining in the container, a dose being defined as the quantity of product used for a single person during a single session. The quality of the colouring substances complies with that…

The declaration provided for in Article L. 513-10-2 shall be sent by any means giving a date certain to the Agence nationale de sécurité du médicament et des produits de santé. It shall indicate 1° The name or corporate name, address and legal nature of the company to which the establishment belongs ; 2° The address of the establishment in France and the exact nature of the planned activity; 3°…

The person responsible for placing a tattoo product on the market, established in France, shall make the file provided for in the third paragraph of article L. 513-10-5 available to the supervisory authorities at the address given in 6° of article R. 513-10-5. This file includes : 1° The qualitative and quantitative formula of the product ; 2° The physico-chemical and microbiological specifications of the raw materials and the tattoo…