Book I: Pharmaceutical products

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…

Any proprietary medicinal product or any other medicinal product manufactured industrially or by a method involving an industrial process, as well as any generator, kit or precursor which is not the subject of a marketing authorisation issued by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, laying down Community procedures for the authorisation and supervision of medicinal…

Once the authorisation provided for in Article L. 5121-8, the Agence nationale de sécurité du médicament et des produits de santé may, under conditions laid down by decree in the Conseil d’Etat, require the holder of the authorisation to carry out, within a period set by the Agency: 1° Post-authorisation safety studies if there are concerns about the safety risks presented by an authorised medicinal product; 2° Post-authorisation efficacy studies…

Inclusion on the list defined in article L. 1121-15 of clinical trials prior to the granting of marketing authorisation is compulsory.

The authorisation provided for in article L. 5121-8 is refused if it appears that the assessment of the positive therapeutic effects of the medicinal product or product with regard to the risks to patient health or public health associated with its quality, safety or efficacy is not considered to be favourable, or that it does not have the qualitative and quantitative composition declared, or that the therapeutic effect announced is…

Where a medicinal product is authorised in another Member State of the European Union or a State party to the Agreement on the European Economic Area, but is not the subject in France of either the marketing authorisation provided for in Article L. 5121-8 or an application under examination for such authorisation, the Agence nationale de sécurité du médicament et des produits de santé may, on justified public health grounds,…