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Classification of Medicines as Regards their Supply

Background

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.

 

Work Programme

According to its Terms of Reference, the primary responsibilities of the Committee of Experts CD-P-PH/PHO are as follows:

  • review the national legal supply status of medicinal products for human use and issue recommendations on the classification of medicines and their supply conditions to health authorities of the Council of Europe member States which are parties to the Ph. Eur. Convention;
  • compile evidence-based classification reviews focusing on therapeutic classes of medicines authorised via decentralised, mutual recognition and national marketing authorisation procedures, relevant for public health but not harmonised in terms of classification status;
  • ensure that the Melclass database is up-to-date and enhance the database overall data quality and completeness (note: the Melclass database contains the CD-P-PH/PHO’s recommendations on the classification of medicines, and national information about the classification status and supply conditions of medicines in member States);
  • examine medication safety signals arising at national and European level as well as recommendations following signal assessments, and assess the need for a revision of the recommendations on the classification status of the medicines of interest.

In addition, the Committee of Experts CD-P-PH/PHO contributes to a joint initiative with the Committees of Experts CD-P-PH/CMED and CD-P-PH/PC that aims to revise Resolution ResAP(2007)2 on good practices for distributing medicines via mail order with a view to aligning it with the latest developments in the field (e.g. new EU regulation concerning online pharmacies, digitalisation of healthcare, e-prescribing).

 

Programme Results

More information about programme results:

Programme results for 2018-2019

Programme results for 2016-2017

Programme results for 2014-2015

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