Title II: Medicinal products for human use

The following definitions apply 1° Magistral preparation means any medicinal product prepared in accordance with a medical prescription intended for a specific patient when there is no suitable or available proprietary medicinal product, including because it is not actually marketed, which has a marketing authorisation, one of the authorisations or a compassionate prescribing framework mentioned in articles L. 5121-9-1, L. 5121-12 and L. 5121-12-1 , a parallel import authorisation or…

The following definitions apply 1° “Investigational medicinal product” means a medicinal product which has been tested or used as a reference, including as a placebo, in a clinical trial; 2° “Authorised investigational medicinal product” means a medicinal product authorised in accordance with Regulation (EC) No 726/2004, or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes made to the labelling of the medicinal product, which is…

The prescription of a proprietary medicinal product shall mention its active ingredients, designated by their international non-proprietary name recommended by the World Health Organisation or, failing this, their pharmacopoeial name. In the absence of such names, the usual common name is given. It may also mention the fancy name of the medicinal product. By way of derogation from the first paragraph, the prescription for one of the medicinal products mentioned…

Any holder of a marketing authorisation for a medicinal product or any operator of such a medicinal product is required, within one year of the promulgation of Act 2011-2012 of 29 December 2011 on reinforcing the safety of medicinal products and health products, to make available to the public on its website the designation of the active ingredients of this medicinal product according to their international non-proprietary name recommended by…

When it is drawn up at the request of a patient with a view to use in another Member State of the European Union, the prescription of one of the medicinal products mentioned in 6°, 14° and 15° of Article L. 5121-1, in Article L. 5121-3, and points a and d of paragraph 1 of Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council…

Products presented as suppressing the desire to smoke or reducing tobacco addiction are considered to be medicines.

Any medicinal product intended for magistral preparations in pharmacies and identified by a special name is subject to the provisions of this chapter and those of article L. 5124-6.

The preparation, import, export, wholesale distribution and brokering of medicinal products, as well as pharmacovigilance, must be carried out in accordance with good practice, the principles of which are defined by decision of the Agence nationale de sécurité du médicament et des produits de santé. For the gene therapy preparations and xenogenic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1, in addition to the activities mentioned…

For the preparations mentioned in 1°, 2° and 3° of Article L. 5121-1, only raw materials meeting the specifications of the pharmacopoeia may be used, unless no raw material meeting these specifications is available and suitable for the preparation in question.

Non-clinical trials intended to assess the properties and safety of medicinal products for human use must comply with good laboratory practice, the principles of which are laid down by decision of the Agence nationale de sécurité du médicament et des produits de santé. Good laboratory practice must guarantee the quality and integrity of test results. They concern the organisation of the laboratory and the conditions under which these tests are…