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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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Article R5132-1 of the French Public Health Code

The provisions of this section apply to the medicinal products mentioned in Article L. 5111-1, where these medicinal products : 1° Are classified, by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, in lists I or II defined in article L. 5132-6, or as narcotic or psychotropic drugs ; 2° Or contain one or more substances or preparations classified, by…

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Article R5132-2 of the French Public Health Code

The following are not subject to the provisions of this section: 1° The medicinal products mentioned in article R. 5132-1 which are intended for human medicine and contain classified substances in very low doses or concentrations or are used for a very short treatment period. The forms or routes of administration of these medicinal products, their composition, their indication, the maximum doses or concentrations of substances they contain and, where…

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Article R5132-3 of the French Public Health Code

The prescription of medicinal products or products intended for human medicine mentioned in the present section is written, after examination of the patient, on a prescription and indicates legibly : 1° The surname and forenames, position and, where appropriate, the title or speciality of the prescriber as defined in article R. 5121-91, his identifier where available, his business address specifying “France”, his telephone number preceded by the international dialling code…

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Article R5132-3-1 of the French Public Health Code

Prescriptions drawn up at the request of a patient with a view to use in another Member State of the European Union include the information provided for in 1°, 3° and 7° of article R. 5132-3 and also indicate: 1° The common name of the medicinal product prescribed, in accordance with the provisions of article R. 5125-55, as well as the dosage of the medicinal product prescribed; 2° The brand…

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Article R5132-4 of the French Public Health Code

The order for professional use of medicinal products intended for human medicine mentioned in this section must indicate legibly : 1° The name, title, registration number, address and signature of the practitioner, as well as the date ; 2° The name and quantity of the medicinal product or product; 3° The words: “Professional use”. The prescriber must sign immediately below the last line of the prescription or render unusable the…

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Article R5132-5 of the French Public Health Code

Prescriptions and all orders for professional use of medicinal products or products intended for human medicine or medicinal products intended for veterinary medicine, classified as narcotics or subject to narcotics regulations, are written on a prescription that meets the technical specifications laid down, after obtaining the opinion of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for…

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