Subsection 1: General provisions

Learning programmes are designed to improve patient care and the correct use of medicines. They are designed to encourage and monitor the appropriation of technical procedures carried out by patients themselves. They may be set up at the request of the Agence nationale de sécurité du médicament et des produits de santé or the European Commission, in particular as part of the risk management plans provided for either in 3°…

The learning programme is made up of elements intended for the patient, the healthcare professional, the doctor or pharmacist in charge of the programme, the treating doctor and the prescribing doctor where applicable. These elements may take the form of documents, materials or actions.

The learning programmes are designed to be consistent with the public health initiatives carried out by the health authorities, health insurance organisations and health establishments, where these exist. They are designed and implemented in accordance with the recommendations made by the competent authorities, in particular those of the Agence nationale de sécurité du médicament et des produits de santé and the Haute Autorité de santé.

Information on learning programmes must be dissociated from any promotional communication relating to the medicinal product covered by the programme and may not be the subject of any direct communication to the public.