ISHS Acta Horticulturae 503: II WOCMAP Congress Medicinal and Aromatic Plants, Part 4: Industrial Processing, Standards & Regulations, Quality, Marketing, Economics
STANDARDS FOR THE ASSESSMENT OF HERBAL MEDICINAL PRODUCTS IN EUROPE AND AROUND THE WORLD |
| Author: | H. Cranz |
| Keywords: | Marketing Authorisation, EEC Directives, Homeopathic Medicines, Herbal Medicinal Products, EMEA, ESCOP, WHO monographs |
| Abstract:
In the EU regulatory and legal rules are needed by a growing demand of and trade for traditional medicines. Since January 1993 progress has been made on classification, package information, advertising and wholesale distribution while the marketing authorisation process is developing. Since September 1992 Directive 92/73/EEG gives additional provisions for Homeopathic Medicines. A Simplified Procedure is foreseen while labels and packages should mention 12 prescribed items. Safety of Herbal Medicinal Products can be proved by clinical trials or by citing published bibliographical references. The European Medicines Evaluation Agency - EMEA - became operational in January 1995; published the first SPC-Summary of Product Characteristics. In 1996 the European Parliament expressed clear support for more and better use of alternative medicines. For a harmonizing system Monographs for widely used medicinal plants are essential. Besides ESCOP the WHO is preparing 60 monographs in coming years. | |
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