Saturday, 4 August 2018

Harmonisation in the classification of medicines


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.

See: EDQM

Posted by Dr. Tim Sandle

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