The declaration provided for in article L. 5131-2 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised to bind the company to which the establishment belongs by any means giving it a date certain. It includes the following information: 1° The name or corporate name and address of the company to which the establishment belongs, as well as the…
The Agence nationale de sécurité du médicament et des produits de santé may, for the purposes of exporting cosmetic products to States which are neither members of the European Union nor parties to the Agreement on the European Economic Area, issue any establishment carrying out one of the activities mentioned in Article L. 5131-2 with a certificate stating that it complies with the good manufacturing practices mentioned in Article 8…
I. – The container and packaging of cosmetic products made available on the market shall bear the information referred to in paragraphs 1 to 3 of Article 19 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products in indelible, easily legible and visible lettering. II. – Any cosmetic product presented non-pre-packaged, packaged at the point of sale at the…
The responsible person shall ensure that the information referred to in Article 21 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products is easily accessible to the public by appropriate means. It shall send this information by any means giving a date certain, within three weeks of receipt of the request.
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 on the market.
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 special precautions for use referred to in point d of paragraph 1 of Article 19 of Regulation (EC) No 1223/2009 of 30 November 2009. “Adverse reaction” means a reaction which is harmful to human health…
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; 3° 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 on cosmetic products and distributors of cosmetic products as defined in Article 2(1)(e) of the…
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 cosmetic products as defined in Article 2(1)(e) of the same Regulation : 1° Must report without delay to the Agence nationale de sécurité du médicament et des produits de santé the serious adverse reactions mentioned in Article 23 of…
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 serious adverse reactions of which they are aware ; 2° May report to the aforementioned agency any other adverse reactions of which they are aware and any reactions likely to result from misuse of the product.
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 any undesirable effects and any effects likely to result from misuse.
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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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