The
Committee of Ministers of the Council of Europe adopted a revised Resolution on
the classification of medicines as regards their supply. It calls on the States
Parties to the Convention on the Elaboration of a European Pharmacopoeia (Ph.
Eur. Convention) to regularly provide information on their national
classifications of medicines for inclusion in the Melclass database and follow
the recommendations to classify active substances on the basis of the supply
conditions of the medicines that contain them, as listed in the database. The
new Resolution CM/Res(2018)1, which supersedes the previous Resolution
ResAP(2007)1 from 2007, will continue to play a key role in providing 800
million citizens across Europe with safe access to medicines and to support
national authorities in ensuring the appropriate and responsible use of
medicines.
The
classification of medicines has implications in terms of patients’ safety,
accessibility to medicines and healthcare expenditure. It also determines the
level of control over the supply of a medicine and has a direct impact on
patients’ access to treatments. The objective of the revised Resolution is to
support the development of uniform and safe supply conditions for medicines for
human use across Europe and to harmonise legislation at national level.
The
information provided by national authorities is included in the Melclass
database, which is hosted by the EDQM and coordinated by its Committee of
Experts on the Classification of Medicines as Regards their Supply
(CD-P-PH/PHO). The database also contains the recommendations on the
classification of medicines that the Committee issues to health authorities in
Member States with a view to harmonise requirements for the supply of medicines
across Europe.
The
revision of the Resolution was carried out by the CD-P-PH/PHO with the
oversight of the European Committee on Pharmaceuticals and Pharmaceutical Care
(CD-P-PH). The new Resolution CM/Res(2018)1 on the classification of medicines
as regards their supply was adopted at the 1313th meeting of the Committee of
Ministers of the Council of Europe.
Posted by Dr. Tim Sandle
