French Public Health Code
In forceI.-The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) is a public establishment under the supervision of the Minister for Health.
II-The Agency assesses the benefits and risks associated with the use of products intended for human health, products listed in Annex XVI of Regulation (EU) 2017/745 falling within its remit and products intended for cosmetic use. It monitors the risk associated with these products and carries out benefit-risk reassessments.
The Agency may request that clinical trials involving medicinal products be carried out in the form of active comparator and placebo-controlled trials. If the person producing or exploiting a medicinal product opposes trials against active comparators, they must justify this.
The Agency participates in the application of laws and regulations and, in the cases provided for by specific provisions, takes decisions relating to the evaluation, testing, manufacture, preparation, import, export, wholesale distribution, brokering, packaging, storage, exploitation, marketing, advertising, putting into service or use of the products mentioned in the first paragraph of this II, and in particular :
1° Medicinal products, including insecticides, acaricides and antiparasitics for human use, magistral, hospital and officinal preparations, narcotic substances, psychotropic or other poisonous substances, essential oils and medicinal plants, raw materials for pharmaceutical use ;
2° Contraceptives and contraceptive products;
3° Medical devices and their accessories;
3°a Non-medical products listed in Annex XVI to Regulation (EU) 2017/745;
4° In vitro diagnostic medical devices and their accessories;
5° Labile blood products;
6° Organs, tissues, cells and products of human or animal origin, including when removed during surgery;
7° Cellular products for therapeutic purposes;
8° Breast milk collected, qualified, prepared and preserved by lactariums;
9° (Repealed) ;
10° (Repealed) ;
11° Processes and equipment intended for the disinfection of premises and vehicles in the cases provided for in Article L. 3114-1 ;
12° (Repealed) ;
13° (Repealed) ;
14° (Repealed) ;
15° Cosmetic products ;
16° The micro-organisms and toxins mentioned in Article L. 5139-1 ;
17° Tattoo products;
18° Software that is not a medical device and that is used by medical biology laboratories for the management of medical biology examinations and during validation, interpretation, appropriate communication in application of 3° of Article L. 6211-2 and the archiving of results;
19° Non-strictly medical devices used in medical laboratories to carry out medical biology examinations;
20° (Repealed) ;
21° Stools collected by the establishments or organisations mentioned in Article L. 513-11-1 and intended for the manufacture of a medicinal product.
III - The Agency participates in the application of the legislative and regulatory provisions mentioned in Title II of Book I of Part One and, in the cases provided for by specific provisions, takes decisions relating to this research.
It ensures the implementation of vigilance systems relating to the products mentioned in II, with the exception of biovigilance and the vigilance system relating to medically assisted procreation, and draws up the pharmacopoeia.
It publishes a summary report of the assessment carried out for each new medicinal product under conditions determined by regulation, as well as the decisions to grant, suspend or withdraw the marketing authorisation referred to in articles L. 5121-8 and L. 5121-9. It organises regular information meetings with the approved associations of patients and users of the healthcare system referred to in article L. 1114-1 on health product safety issues, in particular on action taken to prevent and combat the falsification of medicinal products.
It controls advertising for all products, objects, devices and methods claiming a health purpose, as well as advertising for the products listed in Annex XVI of Regulation (EU) 2017/745 falling within its remit.
It shall take or request the competent authorities to take the necessary animal health measures when the health of the population is threatened, under the conditions provided for in this Code or by any other legislative or regulatory provision aimed at preserving human health.
It draws up an annual report on its activities, which is sent to the Government and Parliament. This report is made public. The report includes the annual assessment of the reassessment of the risk-benefit balance of medicinal products for human use mentioned in article L. 5121-8.
It organises public hearings on public health issues.
The Agency is also responsible for monitoring compliance with the provisions of authorisations issued pursuant to article L. 1161-5.
