Articles
ESCOP MONOGRAPHS – A SCIENTIFIC BASIS FOR HERBAL MEDICINAL PRODUCTS IN EUROPE UNDER SPECIFIC ASPECTS OF THE REGULATORY SITUATION
Article number
503_9
Pages
71 – 74
Language
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.
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.
Authors
B. Steinhoff
Keywords
EEC Directives, SPC, ESCOP, Monographs
Online Articles (28)