The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published “Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)”, introducing the new approach to assessing medicines with a view to their classification, adopted by the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO).
These guidelines are intended to help national competent authorities (NCAs), marketing authorisation holders (MAHs) and other interested parties establish whether a medicinal product should be available with or without a prescription, a decision that depends on several factors. The characteristics of the active substance and pharmaceutical form, the therapeutic indications and the safety profile are considered, as well as the extent to which healthcare professionals’ expertise is needed to diagnose and treat the condition for which the medicinal product is to be used. The nature and degree of any potential risk of misuse or incorrect use are also considered. The CD-P-PH/PHO issues a recommendation for a non-prescription status or exemptions to a prescription-only status if the benefits clearly outweigh the risks, as demonstrated by in-depth Evidence-Based Classification Reviews (EBR), to be published on the dedicated “Database and publications” page on the EDQM website.
Currently chaired by Ms Sandra Monteiro from Infarmed, Portugal’s National Authority of Medicines and Health Products, who was also the Rapporteur for this new document, the CD-P-PH/PHO works to ensure that medicines are classified appropriately across Europe, helping determine whether they should be available as prescription-only or non-prescription drugs. Its mission is to support safe and effective access to medicines by guiding national authorities, promoting harmonisation across countries and protecting public health. This benefits European citizens by enhancing patient safety, harmonising regulatory practices and promoting informed healthcare decisions.
Download “Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)” from FreePub, the EDQM’s free publications platform.
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