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Classification for the supply of medicinal products for human use
1) OBJECTIVE
To harmonize conditions for the supply of medicinal products sold over the counter or on prescription.
2) COMMUNITY MEASURES
Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use.
This Directive is repealed by the Community code relating to medicinal products for human use.
3) CONTENTS
The conditions for the supply of medicinal products for human use need to be harmonized to ensure the free movement of those products within the Community.
The Directive therefore lays down that, when a marketing authorization is granted, the competent authorities must specify the classification of the medicinal product into:
- a medicinal product subject to medical prescription;
- a medicinal product not subject to medical prescription.
The first category may be divided into subcategories:
- medicinal products on renewable or non-renewable medical prescription;
- medicinal products subject to special medical prescription;
- medicinal products on restricted medical prescription, reserved for use in certain specialized areas.
The Directive describes the conditions which place medicinal products in one or another category.
The competent authorities must draw up a list each year of the medicinal products subject on their territory to medical prescription. This list must be communicated each year to the Commission and the other Member States.
4) deadline for implementation of the legislation in the member states
01.01.1993
5) date of entry into force (if different from the above)
6) references
Official Journal L 113, 30.04.1992
7) follow-up work
8) commission implementing measures
Report - COM (97) 581 final - not yet published
Classification for the supply of medicinal products for human use: Commission report to the Council on the application of Directive 92/26/EEC.
According to this report, all Member States have transposed the Directive into their national law and use the classification system laid down in the Directive. This system comprises two main categories: medicinal products subject to medical prescription and medicinal products not subject to medical prescription. Optional subcategories may, however, vary from one Member State to another.
Last updated: 21.12.2007