The classification of a medicine as prescription or non-prescription has a direct impact on patient safety, the accessibility of medicinal products and the management of healthcare expenditure.
Decisions on prescription status are made by national health authorities, and supply conditions vary widely across countries due to differing interpretations of classification criteria and the lack of harmonisation in important additional classification criteria. This lack of harmonisation means that patients in different countries may face very different conditions when trying to obtain the same medicine.
To address this, the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO) issues recommendations on the classification of medicines. In 2025, the committee introduced a new type of assessment, outlined in the Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status).
These guidelines are intended to assist stakeholders involved in determining whether a medicinal product is suitable for prescription or non-prescription status.
This webinar:
- introduces the new CD-P-PH/PHO assessment approach to issuing recommendations on the classification of medicines as prescription or non-prescription;
- explains the rationale behind the committee’s recommendations;
- walks the participants through the two-stage assessment;
- shows how the CD-P-PH/PHO classification guidelines can be used at national level, incorporating experience from Portugal;
- explains how medicines are reclassified, i.e. how their supply status is modified;
- describes the reclassification process in the United Kingdom, a Council of Europe member state;
- highlights the importance of harmonising the supply status of medicines.
Target audience
This webinar is of interest to health authorities and policy makers, the pharmaceutical industry, pharmacists, physicians and other prescribers, patients and academia (pharmacy, medicine, etc.).
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Duration : 1 hours, 18 minutes
Download the presentations
- Introduction to Council of Europe, EDQM and CD-P-PH/PHO - Daniela Mayerová
- Understanding the new CD-P-PH/PHO classification approach & experience from Portugal - Sandra Monteiro
- UK Reclassification - Process and Timetable - Ravina Barrett
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