Article R5131-11
Professional users and consumers, in accordance with the second and third paragraphs of II of Article L. 5131-5, may report to the Agence nationale de sécurité du médicament et des produits de santé a…
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Showing 7341–7350 of 19551 articles for “Art. CE 28-5-2010 n° 330567”
Professional users and consumers, in accordance with the second and third paragraphs of II of Article L. 5131-5, may report to the Agence nationale de sécurité du médicament et des produits de santé a…
The declarations provided for in Article L. 5131-5 shall be made in accordance with the procedures and standard form laid down by order of the Minister for Health on a proposal from the Director Gener…
…ay use the information referred to in Articles R. 5131-9 to 11 for the purposes of market surveillance, market analysis, evaluation and consumer information under Articles 25, 26 and 27 of the Regulat…
The vigilance exercised over cosmetic products by the Agence nationale de sécurité du médicament et des produits de santé includes : 1° Receiving and recording serious adverse reaction reports sent by…
Cosmetic products are subject to vigilance designed to monitor all undesirable effects and misuse resulting from their use. This vigilance is applied to all these products once they have been placed o…
The national cosmetovigilance system comprises : 1° The National Agency for the Safety of Medicines and Health Products ; 2° The Directorate-General for Consumer Affairs, Competition and Fraud Control…
…n health attributable to the normal or reasonably foreseeable use of a cosmetic product, in accordance with Article 2(1) o of the same Regulation. "Serious undesirable effect" means an undesirable eff…
The Direction Générale de la Consommation, de la Concurrence et de la Répression des Fraudes communicates to the Agence Nationale de Sécurité du Médicament et des Produits de Santé the declarations of…
…f Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products and distributors of cosmetic products as defined in Article 2(1)(e) of the…
…lication of the first paragraph of II of Article L. 5131-5: 1° Must report without delay to the Agence nationale de sécurité du médicament et des produits de santé any serious adverse reactions of whi…
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