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Article R513-10-11 of the French Public Health Code

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…

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Article R513-10-12 of the French Public Health Code

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…

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Article R513-10-14 of the French Public Health Code

The information made available to the public is : 1° The qualitative formula expressed in the form of the list of ingredients mentioned in 8° of article R. 513-10-5 ; 2° In addition, for the dangerous substances included in the composition of the tattoo product and mentioned in article L. 1342-2 of this code, the quantity expressed as a percentage, in the form of a concentration range or a maximum…

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Article R513-10-15 of the French Public Health Code

Any person wishing to obtain the information provided for in the previous article shall submit a request by post to the address mentioned in 6° of article R. 513-10-5 or by fax or electronically to the contact details mentioned in 9° of the same article, specifying in particular the name of the product, its brand and, where applicable, its colour. The manufacturer or the person responsible for placing the product…

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