French Business Law - French Legislation

Article L5121-13 of the French Public Health Code

November 7, 2023

Homeopathic medicinal products which satisfy all the conditions listed below are not subject to the marketing authorisation provided for in Article L. 5121-8: 1° Oral or external administration ; 2° No specific therapeutic indication on the labelling or in any information relating to the medicinal product; 3° Degree of dilution guaranteeing the safety of the medicinal product; in particular, the medicinal product may contain neither more than one part per…

Article L5121-14 of the French Public Health Code

November 7, 2023

The registration provided for in Article L. 5121-13 may cover a series of homeopathic medicinal products obtained from the same homeopathic stock or stocks. The application for registration must be accompanied by documents demonstrating the quality and homogeneity of the batches manufactured for these homeopathic medicinal products.

Article L5121-14-1 of the French Public Health Code

November 7, 2023

Traditional herbal medicinal products that meet the following criteria are not subject to marketing authorisation: 1° They are designed to be used without the intervention of a doctor for the purposes of diagnosis, prescription or monitoring of treatment; 2° They are exclusively intended to be administered according to a specified dose and dosage; 3° They are administered orally, externally or by inhalation; 4° The period of traditional use has elapsed;…

Article L5121-14-2 of the French Public Health Code

November 7, 2023

I. – Without prejudice to decisions to vary, suspend or withdraw marketing authorisations, the Agence nationale de sécurité du médicament et des produits de santé may, in the interests of public health, prohibit the prescription and supply of a proprietary medicinal product and withdraw it from the market under conditions laid down by decree in the Conseil d’Etat, and in particular for one of the following reasons: 1° The proprietary…

Article L5121-14-3 of the French Public Health Code

November 7, 2023

The company which exploits a proprietary medicinal product contributes to its proper use by ensuring in particular that the product is prescribed in compliance with its marketing authorisation referred to in Article L. 5121-8 and, where applicable, its authorisations or compassionate prescription frameworks mentioned in articles L. 5121-12 and L. 5121-12-1, its registration mentioned in articles L. 5121-13 or L. 5121-14-1, its authorisation mentioned in article L. 5121-9-1 or its…

Article L5121-18 of the French Public Health Code

November 7, 2023

Persons liable for the contribution provided for in I of Article L. 245-6 of the Social Security Code and persons liable for value added tax pursuant to Article 256 A of the General Tax Code who make the first sale in France of medical devices defined in Article L. 5211-1 of this Code and in vitro diagnostic medical devices defined in Article L. 5221-1 sociale send to the agency mentioned…

Article L5121-20 of the French Public Health Code

November 7, 2023

The procedures for applying this chapter are determined by decree in the Conseil d’Etat, and in particular : 1° The scientific criteria justifying, where appropriate, exemption from bioavailability studies for generic proprietary medicinal products as defined in 5° of Article L. 5121-1, the procedure for inclusion in the register of generic groups referred to in Article L. 5121-10, as well as the procedures for inclusion in an existing generic group…

Article L5121-21 of the French Public Health Code

November 7, 2023

I.-For the application of article L. 5121-1 : 1° Army hospitals are considered to be health establishments ; 2° The Armed Forces Central Pharmacy may be authorised to make the hospital preparations mentioned in the last three paragraphs of 2° of the same Article L. 5121-1. II – The provisions of this Title relating to gene therapy preparations and xenogenic cell therapy preparations referred to in 12° and 13° of…

Article L5121-22 of the French Public Health Code

November 7, 2023

The purpose of pharmacovigilance is to monitor, assess, prevent and manage the risk of adverse reactions resulting from the use of the medicinal products and products mentioned in article L. 5121-1.

Article L5121-24 of the French Public Health Code

November 7, 2023

Any company or organisation exploiting a medicinal product or a product mentioned in article L. 5121-1 is required to comply with its obligations in terms of pharmacovigilance and, in particular, to implement a pharmacovigilance system and to record, report and monitor any adverse reaction suspected of being due to a medicinal product or product mentioned in the same article L. 5121-1 of which it is aware and to set up…

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Legislative part

Article L5121-13 of the French Public Health Code

Article L5121-14 of the French Public Health Code

Article L5121-14-1 of the French Public Health Code

Article L5121-14-2 of the French Public Health Code

Article L5121-14-3 of the French Public Health Code

Article L5121-18 of the French Public Health Code

Article L5121-20 of the French Public Health Code

Article L5121-21 of the French Public Health Code

Article L5121-22 of the French Public Health Code

Article L5121-24 of the French Public Health Code

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