Danish Medicines Agency

Requirements for authorization of generic epilepsy medicine made stringent

Published in Law and Health Weekly, October 22nd, 2005

On June 1, 2005, it became possible to market copies of epilepsy medicine containing lamotrigine, when the patent of the original product Lamictal expired.

In this connection, the Danish Medicines Agency would like to draw doctors' and patients' attention to the introduction of increasingly stringent requirements for authorization of substitution and thereby pharmacies' possibility for automatic substitution. The more stringent requirements are intended to ensure that epilepsy patients can confidently change between different copies of their medicine.

Generic medicine is often authorized by means of demonstration of a so-called 'bioequivalence',...

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Source: Law and Health Weekly (2005-10-22)

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