Taking into consideration the complex and technical nature of the task this Committee of experts has been entrusted to:

● to revise the text of the Resolution on the classification of medicines which are obtainable on prescription as appropriate;

● to revise annually the classification of substances appended to the resolution;

● to constitute a privileged platform for concerned authorities to exchange information on classification practice and rationale.

The Committee of experts convened for the first time in 1972.

Since long the Council of Europe is concerned with the supply conditions of medicines for human use and the harmonisation of national legal provisions, from the perspective of patient safety and public health protection. The initial Recommendation AP (61) 2 was drawn up in 1961 to control a growing tendency of mis- and overuse of sedative and narcotic medicinal products by empowering the competent authorities to classify new medicinal products into prescription and non-prescription medicines by considering risks associated to the active substance as well as conditions of use.

Working concept

The Committee of experts on the legal classification of medicines as regards their supply is a subordinate body of the Committee of experts on pharmaceutical questions.

The terms of reference of the Committee of experts are part of the overall aim and are related to:

● providing to concerned authorities, the public and industry a reference on the recommended classification of medicines’ substances and conditions of use associated to the classification;

● fulfilling the role of an early signal post monitoring trends in national classification practice related to the safety and accessibility of medicines via the obtained information;

● ensuring a platform for an effective information exchange between competent authorities (national drug agencies) to facilitate their tasks, which rely on taking into account or even recognising European evidence and decisions.

The member states consider the Committee meetings a forum particularly suited for the exchange of classification information much beyond the annual publication of the updated appendices, which proves certainly useful for the review of Marketing authorisation holder’s requests for a changed classification status.

To this end the Committee of experts is in charge of issuing annually the revised appendices to Resolution AP (2000)1 as a part of its retrospective work on the basis of national reports.

In general the classification takes into consideration the national assessments of direct and indirect risks which may occur under normal treatment conditions and under medical surveillance as well as from foreseeable mis- or abuse.

Independent from routine information exchange, the Committee of experts elaborates reviews on the classification practice and underlying rationale for medicines of specific interest or concerns in a prospective manner and monitors safety and non-safety related withdrawals of medicines made of substances classified.

European industry branch association are not entitled to send representatives to the meetings of the Committee of experts. However, industry branch associations provide regularly information updates on non-prescription medicines for the meetings of the Committee of experts.

The European branch industry considers the annually revised appendices of Resolution AP (2000) 1 as a reference.

Since 2000 the Committee of experts has been constantly revising its working methods towards a rationalisation.

In 2002/2003 a database system was developed to store national data on the medicines’ classification and conditions of use and the appendices to Res AP (2000) 1 and is hosted by the Council of Europe. The existing information on the classification of medicines and associated conditions of use, compiled by the member states delegations has been transferred and the system is operational. Individual authorities may perform searches on available information.