French Public Health Code
In forceThe marketing authorisation is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
The authorisation includes the national number identifying the presentation of the medicinal product provided for in Article R. 5121-4.
It indicates, where applicable, the classification of the medicinal product in the following categories:
1° Medicinal product subject to prescription by virtue of its inclusion on one of the lists defined in article L. 5132-6 ;
2° Medicinal product subject to special prescription due to its classification as a narcotic or the application of the provisions of articles R. 5132-23 or R. 5132-39 ;
3° A medicinal product subject to restricted prescription pursuant to the provisions of article R. 5121-77.
For a medicinal product classified in one of the categories of medicinal products mentioned in 1°, 2°, 3° or 4° of article R. 5121-77, it includes, where applicable, the words " Article R. 5121-96 of the Public Health Code" and designates the authorised users. For a medicinal product classified in the category of medicinal products for which prescription is reserved for certain specialist doctors, it indicates the speciality or specialities required to be able to prescribe it.
Where applicable, it indicates that the medicinal product may only be dispensed to healthcare professionals authorised to prescribe and administer them by virtue of article R. 5121-80.
Where applicable, it sets out the restrictions or prohibitions on advertising to the general public provided for in the first paragraph of article L. 5122-6.
It indicates the frequency of transmission of the periodic safety update report mentioned in article R. 5121-168.
The authorisation is accompanied by the summary of product characteristics mentioned in article R. 5121-21, the wording of the package leaflet and the wording of the labelling, as approved by the Director General of the Agency.
