(2000; 31 pages)
4.1 Assessment of new active substances not marketed as prescription medicines and designed specifically for use in self-medication
The material should comprise pharmaceutical, pharmacological (preclinical and general pharmacological characterization of the compound), toxicological, clinical pharmacological (clinical trials) and long-term therapeutic data (efficacy and safety) obtained in appropriate experimental animals and humans. It will then need to be submitted to the regulatory authority for review. The clinical trials must address the specific issue of the use of the medicinal product in a representative self-medication population. Sufficient clinical experience of the use of a new active substance must be gained before marketing authorization of the product for self-medication can be granted.