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Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
Open this folder and view contents3. General basis for regulatory assessment
Open this folder and view contents4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
View the documentAnnex
View the documentAcknowledgements


The text of these guidelines was discussed
and reviewed in a consultation on 15 - 16
April 1999 in Geneva. The participants were:
Dr D. Bowen (Rockville, MD, USA), Mr G.
Kisuule (Kampala, Uganda), Dr H.
Ogasawara (Tokyo, Japan), Dr Ch.J.P.
Siregar (Bandung, Indonesia), Mrs G.A.
Williams (London, UK); Observers: Ms C.
Hall (IFPMA), Dr G. Lingam (IFPMA), Dr S.
Mann (WSMI), Dr J.A. Reinstein (WSMI);
Secretariat: Dr M. Couper, Dr J. Idänpään-
Heikkilä, Mr J. Yoshida (WHO, Geneva).


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