Subsection 6: Medicinal products requiring special monitoring during treatment.

Classification as a medicinal product requiring special monitoring during treatment can only be made if the restrictions on prescribing the medicinal product are justified by the seriousness of the undesirable effects that its use may cause.

The classification of a medicinal product in the category of medicinal products requiring special monitoring during treatment has the effect of making its prescription subject to periodic examinations which the patient must undergo.

The marketing authorisation, the early access authorisation pursuant to 1° of II of article L. 5121-12 or the compassionate access authorisation pursuant to II of article L. 5121-12-1 or the compassionate prescription framework pursuant to III of article L. 5121-12-1 or the import authorisation for the medicinal product classified in the category of medicinal products requiring special monitoring during treatment indicates the nature and frequency of the examinations which the…