These guidelines provide an overview of the key considerations of the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, when issuing recommendations on the classification of supply of an active substance used in a medicinal product for a specific therapeutic purpose.
They may serve as guidance to marketing authorisation holders (MAHs), national competent authorities
(NCAs) or other interested parties in determining whether a medicinal product may be considered suitable
for prescription or non-prescription status.