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Article R5131-12 of the French Public Health Code

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 the parties mentioned in Articles R. 5131-9 to 11 and transmitting the information reported under the conditions set out in paragraphs 2 to 4 of Article 23 of Regulation (EC) No 1223/2009 of the European Parliament and of the…

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Article R5131-13 of the French Public Health Code

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 serious undesirable effects brought to its attention as part of its mission to monitor the cosmetics market.

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Article R5131-14 of the French Public Health Code

The competent authorities referred to in Article L. 5131-3 may 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 Regulation referred to in Article R. 5131-12.

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Article R5131-15 of the French Public Health Code

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 General of the National Agency for the Safety of Medicines and Health Products.

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