The Contribution of the European Scientific Cooperative on Phytotherapy and World Health Organization Monographs
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Drug Information J o u m l . Vol. 33. pp. 17-22, 1995’
Copyright 0 1999 Drug Information Association Inc.
Printed in the USA. All rights resewed.
THE CONTRIBUTION OF THE EUROPEAN SCIENTIFIC COOPERATIVE ON PHYTOTHERAPY AND WORLD HEALTH ORGANIZATION MONOGRAPHS BARBARA STEINHOW, PHD German Medicines Manufacturers’ Association, Bonn, Germany
This paper presents an overview of the new European marketing authorization system and its impact on herbal medicinal products. The bibliographic application option and assessment criteria for herbal medicinal products are explained. The role of the European Scientific Cooperation on Phytotherapy and the World Health Organization and the contribution of their monographs on herbal medicinal products in the marketing authorization process are covered. Key Words: Europe; Herbal medicinal products; European Scientific Cooperative on Phytotherapy; World Health Organization
INTRODUCTION: THE NEW EUROPEAN MARKETING AUTHORIZATION SYSTEM
cific arbitration procedure. In accordance with the new legislation, this decision is binding and may have-in the case of a negative result-a negative “rebound effect” on THE EUROPEAN DECENTRALIZED pro- the first registration in a Member State. That cedure for marketing authorization repre- means that under this decentralized applicasents a system of mutual recognition of mar- tion system the first registration might be lost keting authorization decisions and provides, unless the applicant does not withdraw its as a general rule, that the assessment of one application for recognition of the dossier. national authority should be sufficient for This situation is rather dangerous for herbal subsequent registration in other Member medicinal products because of different asStates. In the optimum case, the approval sessment criteria and different traditions. In granted by the First Member State is adopted fact, until February 1998, only two applicaby the Concerned Member States. If differ- tions were successful, namely, two products ences in evaluation occur between national containing Ispaghula husk (Plantago ovata). Within the marketing authorization proauthorities, a decision will be made by a specedure, the so-called “Summary of Product Characteristics (SPC)” approach by the first Presented at the DIA loth EuroMeeting, March 30authority is one of the basic elements. It repApril 1, 1998, Nice, France. resents the main characteristics of the prodReprint address: Dr. Barbara Stcinhoff, German Medicines Manufacturers’ Association, Ubierbstrasse uct, for example, active ingredient, indication, dosage, contraindications, side effects, 71-73. D-53173 Bonn, Germany. E-mail: steinhoffa bah-bonn.de shelf life, and so forth. 17 Downloaded from dij.sagepub.com at KAI NAN UNIV on April 25, 2015
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Barbara Steinhoff
THE OPTION OF BIBLIOGRAPHIC APPLICATIONS In most cases, herbal medicinal products have well-known active ingredients for which a lot of experience exists in several countries; thus, performance of new clinical and pharmacologicdtoxicological studies d
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