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…
The following are laid down by order of the Minister for Health, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° The list of substances that may not be used in tattooing products; 2° The list of substances that may not be used in tattooing products, unless they comply with the restrictions and conditions set out in this…
Without prejudice to the information required by other legislative or regulatory provisions, the container and packaging of each unit of tattooing product placed on the market free of charge or against payment must include the following information, written in such a way as to be legible, comprehensible and indelible: 1° The name of the product ; 2° The nominal content at the time of packaging, indicated by mass or volume;…
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…
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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