The Council of Europe has been long concerned with the supply conditions for medicines for human use and the harmonisation of national legislation in this field.
The classification status of medicines authorised in Europe remains a competency of the member states. The classification status of medicines has implications on patient safety, the accessibility of medicines and management of health care expenditure. There is a growing trend towards classifying medicines as over-the-counter (OTC) medicines.
In continuing with the programme of activities carried out under the aegis of the former Partial Agreement in the Social and Public Health field, the Committee of Experts on the classification of medicines as regards their supply (CD-P-PH/PHO) was entrusted with reviewing classification practice at the national level.
In the absence of harmonised legislation, the CD-P-PH/PHO has given priority to:
setting standards for classifying medicines;
revising annually the appendices of Committee of Ministers' Resolution ResAP (2007)1 on the classification of medicines as regards their supply; and
maintaining the database, MELCLASS, hosted by the EDQM.
Revisions of the appendices of Resolution ResAP(2007)1 on the classification of medicines as regards their supply (available in Melclass database)
Evidence-based classification reviews:
- Report classification/justification of antibiotics and chemotherapeutics for dermatological use, Racecadotril
More information about programme results: