Article L5121-10-3
The holder of an intellectual property right protecting the appearance and texture of the oral pharmaceutical forms of a reference medicinal product within the meaning of Article L. 5121-1 may not pro…
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Showing 2811–2820 of 46416 articles for “Art. CE 10-2-2017 n° 387960”
The holder of an intellectual property right protecting the appearance and texture of the oral pharmaceutical forms of a reference medicinal product within the meaning of Article L. 5121-1 may not pro…
…e marketed until ten years have elapsed following the initial marketing authorisation of the reference medicinal product. However, this period is extended to eleven years if, during the first eight ye…
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…
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 o…
…the market is required, in the event of serious doubt as to the harmlessness of one or more substances, to provide the Director General of the Agence nationale de sécurité du médicament et des produi…
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 produ…
…ct, whether free of charge or against payment, is subject to the transmission to the poison control centres mentioned in article L. 6141-4, designated by joint order of the ministers responsible for c…
The person responsible for placing the tattoo product on the market shall make available to the public, by appropriate means, including electronic means, information relating to the composition and ad…
…r placing a tattoo product on the market is obliged to participate in the national system of vigilance exercised over tattoo products by declaring, without delay, to the Agence nationale de sécurité d…
The regional or inter-regional health plan and decisions to authorise activities or heavy equipment may be appealed to the Minister for Health, who will rule within a maximum of six months, after obta…
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