Title I: General provisions relating to medicinal products

I.- Medicinal product for human use means any substance or combination of substances presented as having properties for treating or preventing disease in human beings, as well as any substance or combination of substances which may be used in human beings or which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological…

A pharmaceutical speciality is any medicine prepared in advance, packaged in a particular container and identified by a special name.

Falsified medicinal product means any medicinal product, as defined in Article L. 5111-1, involving a misrepresentation of: 1° Its identity, including its packaging and labelling, its name or its composition with regard to any of its constituents, including excipients, and the dosage of these constituents; 2° Its source, including its manufacturer, country of manufacture, country of origin or marketing authorisation holder; 3° Or its history, including authorisations, registrations and documents…

Medicinal products or classes of medicinal products of major therapeutic interest are defined as medicinal products or classes of medicinal products for which an interruption of treatment is likely to jeopardise the patient’s vital prognosis in the short or medium term, or represents a significant loss of opportunity for patients in view of the seriousness or progressive potential of the disease.