Section 3: Addictovigilance

The following definitions apply 1° Drug dependence: a set of behavioural, cognitive and physiological phenomena of varying intensity, in which the use of one or more psychoactive substances becomes a high priority, the essential characteristics of which are the obsessive desire to obtain and take the substance or substances in question and the constant search for them; the state of dependence may result in the self-administration of these substances in…

The provisions of this section apply to substances or plants having a psychoactive effect, as well as to medicines or other products containing them, with the exception of ethyl alcohol and tobacco.

The Agence nationale de sécurité du médicament et des produits de santé is responsible for implementing addictovigilance. It defines the guidelines, leads and coordinates the actions of the various parties involved and ensures compliance with the monitoring procedures organised by this section.

Persons manufacturing or marketing the substances, plants, medicinal products and other products mentioned in article R. 5132-98 shall, at their request, provide the Director General of the Agence nationale de sécurité du médicament et des produits de santé with all information relating to drug dependence and abuse concerning their products, as well as information concerning their sale.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé provides all relevant information to the European Medicines Agency, as well as to the International Narcotics Control Board of the United Nations and to the World Health Organisation in application of the international conventions on narcotic drugs and psychotropic substances.

Any doctor, dental surgeon or midwife who becomes aware of a serious case of pharmacodependence, abuse or misuse of a substance, plant, medicinal product or other product mentioned in article R. 5132-98 must immediately report it to the centre for assessment and information on pharmacodependence in whose territory the case was discovered. Similarly, any pharmacist who becomes aware of a serious case of pharmacodependence, abuse or serious misuse or serious…

Any company or organisation exploiting a medicinal product or product mentioned in article R. 5132-98 must immediately report any serious case of pharmacodependence, abuse or misuse of this medicinal product or product of which it is aware to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

The drug dependence and addictovigilance assessment and information centres carry out their vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.

An order of the Minister for Health, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé and after consultation with the Commission nationale de l’informatique et des libertés, defines the operating procedures for the computer system, common to all drug dependence and addictovigilance assessment and information centres, designed to collect, record, evaluate and use data relating to cases…