Chapter I: General provisions.

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;…

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…

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…

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…

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…

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…