Section 12: Notice

The marketing authorisation holder must comply with the good package leaflet practices established by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

The presence of an information leaflet for the user in the packaging of any medicinal product or product is compulsory, unless the information referred to in article R. 5121-149 appears directly on the outer packaging or the immediate packaging. It must be written in French, in terms that are easy for the user to understand and sufficiently legible, taking into account the results of consultation with groups of patients. It…

The package leaflet is drawn up in accordance with the summary of product characteristics. It includes a standard text, expressly inviting patients to report any suspected adverse reaction to their doctor, pharmacist or any other health professional or directly to the regional pharmacovigilance centre, and specifying the various reporting methods available to them. It also includes, in order, the following information: 1° For the identification of the medicinal product or…