Article R5131-14
…petent 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 in…
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Showing 6911–6920 of 39773 articles for “Art. R. 145-5”
…petent 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 in…
…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…
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…
For the purposes of this section, : "Misuse" means use which does not comply with the intended purpose of the product, its normal or reasonably foreseeable use or its instructions for use, or with the…
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…
The responsible person as determined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products and distributors of cos…
Health professionals, in application 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 seri…
…h veterinarians, pharmacists and members of the other health professions mentioned in 4° of article R. 5141-93 are subject are defined, on a proposal from the Director General of the Agence nationale…
…referred to in article L. 6141-4 and the regional pharmacovigilance centres referred to in article R. 5121-167 shall transmit, without delay, to the Agence nationale de sécurité sanitaire, de l'alime…
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