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 availability of medicines with or without a medical prescription has implications on patient safety, accessibility of medicines to patients and responsible management of health care expenditure.
The decision on prescription status and related supply conditions is a core competency of national health authorities. The conditions of the supply of medicines vary considerably in Council of Europe member states, due to the fact that the provisions are differently interpreted and implemented by the member states, and that important additional classification criteria are not harmonised.
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) reviews the classification practice at the national level and issues recommendations on the classification of medicines and their supply conditions to health authorities of the Council of Europe member states parties to the Ph. Eur. Convention.
In the absence of harmonised legislation, the CD-P-PH/PHO has given priority to:
- setting standards for classifying medicines,
- revising the appendices of Committee of Ministers Resolution CM/Res(2018)1 on the classification of medicines as regards their supply (superseding Resolution ResAP(2007)1 on the classification of medicines as regards their supply),
- maintaining a database, MELCLASS, hosted by the EDQM, which contains the recommendations that the CD-P-PH/PHO issues to health authorities of the Council of Europe member states parties to the Ph. Eur. Convention, as well as national information about the classification status and supply conditions of medicines in these member states.
- Revisions of the appendices of Resolution CM/Res(2018)1 on the classification of medicines as regards their supply (available in MELCLASS database)
- Evidence-based classification reviews:
More information about programme results: