Active substances may only be imported from third countries if they have been manufactured in accordance with standards of good practice at least equivalent to those laid down by the European Union, and if they are accompanied by documents defined by regulation attesting in particular to compliance with such standards.
Falsified raw material for pharmaceutical use means any active substance or any excipient, the pharmaceutical use of which is established, which is misrepresented as to its identity, including its packaging and labelling, its name or composition, its origin, including its manufacturer, its country of manufacture, or its history, including authorisations, declarations and documents relating to the distribution channels used.
This chapter covers micro-organisms and toxins the use of which could present a risk to public health, as well as products containing them. An order of the Minister for Health, made on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, shall establish the list of these micro-organisms and toxins. Where these micro-organisms and toxins are intended for veterinary use, the…
The production, manufacture, transport, import, export, possession, offer, transfer, acquisition and use of micro-organisms and toxins included on the list provided for in article L. 5139-1 and products containing them are subject to conditions and an authorisation system defined by decrees of the Conseil d’Etat. These decrees may, after consultation with the national academies of medicine and pharmacy, prohibit any operation relating to these micro-organisms, toxins and products containing them…
When they have the status of Community goods and are originating from or destined for other Member States of the European Union, micro-organisms and toxins included on the list provided for in article L. 5139-1 as well as products containing them must be presented to the customs service, together with the accompanying documents. The customs officers are responsible for endorsing the import or export authorisation provided for in this code,…
Tattooing products are defined as any colouring substance or preparation intended to create a mark on the superficial parts of the human body by breaking the skin, with the exception of products which are medical devices within the meaning of article L. 5211-1.
The opening and operation of any establishment manufacturing, packaging or importing tattoo products, even on an ancillary basis, as well as the extension of an establishment’s activity to include such operations, are subject to a declaration to the Agence nationale de sécurité du médicament et des produits de santé. This declaration is made by the person responsible for placing the tattoo products on the market, who is, depending on the…
Tattoo products must be manufactured in accordance with good manufacturing practice, the principles of which are defined by order of the ministers responsible for consumer affairs and health, issued on a proposal from the Agence nationale de sécurité du médicament et des produits de santé. Assessment of the safety for human health of these products is carried out in accordance with good laboratory practice, the principles of which are published…
Tattoo products placed on the market must not harm human health when applied under normal or reasonably foreseeable conditions of use, taking into account, in particular, the presentation of the product, the information on the label and any other information intended for consumers.
A tattooing product may only be placed on the market, whether free of charge or for a fee, if it meets the following conditions: 1° Its container and packaging must bear the name or company name and address of the person responsible for placing the product on the market, as well as any other information required by regulation; 2° The person responsible for placing the product on the market must…
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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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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