Tamás Paál describes the country’s new unique regulatory procedure for officially authorising off-label prescriptions.
In the European Union, off-label prescribing is not regulated by Community law. Having left the legal interpretation up to the competent authorities in individual member states, the European legislation governing medicinal products for human use (Directive 2001/83/EC as amended) states only that a “Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order…, for use by an individual patient under his direct personal responsibility”...
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