ISHS Acta Horticulturae 503: II WOCMAP Congress Medicinal and Aromatic Plants, Part 4: Industrial Processing, Standards & Regulations, Quality, Marketing, Economics
ESCOP MONOGRAPHS - A SCIENTIFIC BASIS FOR HERBAL MEDICINAL PRODUCTS IN EUROPE UNDER SPECIFIC ASPECTS OF THE REGULATORY SITUATION |
| Author: | B. Steinhoff |
| Keywords: | EEC Directives, SPC, ESCOP, Monographs |
| Abstract:
Following Directives 65/65/EEC and 75/318/EEC pharmaceutical products require pre-marketing approval. Requirements for quality, safety and efficacy are given in Directives91/507/EEC and 75/319/EEC. A system of mutual recognition of marketing authorization, the "decentralized procedure" has started taking into account the "Summary of Product Characteristics(SPC)" of the first member state authority. For well-known active ingredients a "bibliographic procedure" can be applied. Since 1990 ESCOP, the European Scientific Cooperative on Phytotherapy is establishing criteria for the assessment of medicinal herbal products by publishing 50 monographs including a Summary of Product Characteristics(SPC). In future there will be cooperation with the EMEA in London. | |
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