Book I: Pharmaceutical products

Prescribers may make the dispensing of certain medicines conditional on the performance and results of medical tests, in particular biological or diagnostic tests, by means of a prescription known as a conditional dispensing prescription.

In the absence of the authorisation or compassionate prescribing framework mentioned in article L. 5121-12-1 for the indication in question, a medicinal product may only be prescribed in a manner that does not comply with its marketing authorisation if there is no appropriate medicinal product alternative with a marketing authorisation or early access authorisation and provided that the prescriber considers it essential, in the light of proven medical knowledge, to…

I.-To meet specific defence needs, the Minister for Defence may authorise the armed forces health service to use a proprietary medicinal product outside the conditions of prescription and supply laid down in its marketing authorisation, after obtaining the opinion of the Director General of the National Agency for the Safety of Medicines and Health Products. II.-To meet specific defence needs, the Minister for the Interior may authorise these structures to…

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…

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.

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…