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Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) View the PDF document
Table of Contents
View the documentACKNOWLEDGMENTS
View the documentPREFACE
View the documentEXECUTIVE SUMMARY
Open this folder and view contents1. INTRODUCTION
View the document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
View the document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Open this folder and view contents4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Open this folder and view contents5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
View the document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Open this folder and view contents7. SUMMARY ANALYSIS
View the document8. CONCLUSIONS
View the documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
View the documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
View the documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
View the documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
View the documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
View the documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the documentANNEX 4 (b): Certificate of a Pharmaceutical Product
View the documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
View the documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
View the documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
View the documentANNEX 6: List of Participants in the Study
View the documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
View the documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
View the documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Open this folder and view contentsANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
View the documentBACK COVER
 

ACKNOWLEDGMENTS

This report is a result of the collective efforts of Member States, government institutions, international organizations, nongovernmental organizations and individual professionals, whose contribution to the study is greatly appreciated.

The Action Programme on Essential Drugs (DAP) and the Division of Drug Management and Policies (DMP) carried out the study jointly with the financial assistance of the Office of Health, US Agency for International Development (USAID).

The study was initiated by Dr F.S. Antezana, Assistant Director-General (ADG) of the World Health Organization in 1992. At the time of commencement, he was the Director of DAP.

The methodology for the study was planned and developed with the suggestions, guidance and full participation of:

Dr F.S. Antezana, ADG, WHO
Ms Lois Ann Beaver, United States Food and Drug Administration, USA
Mr Anthony F. Boni, USAID, USA
Mrs Maire Casey-Stapleton, UK
Mrs Margaretha Helling-Borda, Director, DAP, WHO
Mr Steinar Holand, DAP, WHO
Dr J. Idänpään-Heikkilä, Associate Director, DMP, WHO
Dr D. Magrath, Chief, Biologicals, DMP, WHO
Dr A. Mechkovski, Chief, Quality Assurance, DMP, WHO
Mr James Rankin, Management Sciences for Health, USA
Mr Edwin Rivera-Martinez, United States Food and Drug Administration, USA
Ms Agathe Wehrli, Chief, Regulatory Support, DMP, WHO
Dr Witold Wieniawski, Polish Pharmacopoeia Commission, Poland.

The Ministries of Health of: Benin, Cameroon, Central African Republic, Ecuador, Fiji, France, India, Jamaica, Kenya, Malawi, Malaysia, Myanmar, Papua New Guinea, Sri Lanka, Tanzania, Tunisia, Yemen; the International Dispensary Association (IDA), the Netherlands, and the United Nations Children's Fund, Supply Division, Denmark, willingly participated in the study.

Participants in the field visits were:

International team members:

Dr Marcelo Vernengo, Argentina; Mr Pascal Coffi Hessou, Benin; Mr Anacet Baza, Burundi;
Mr E. Kkolos, Cyprus; Mr Eshetu Wondemagegnehu, Ethiopia; Mr Patric Becu, France;
Dr Prem Gupta, India; Yeap Boon Chye, Malaysia, Dr Witold Wieniawski, Poland;
Ms Amy Lim and Mr Yip Lung Wong, Singapore; Mr E. Rivera-Martinez, USA;
Mr Aidan Chidarikire, Zimbabwe.

National team members:

Mr Eugène K. Déguénon and Mr Adolphe Topanou, Benin; Mr Ngueleze and Mr Ndo Jean Rollin Bertrand, Cameroon; Mr Jacob Ngaba and Mr David Kilayo, Central African Republic; Dr Elvira Marchan and Dr Federico Santos, Ecuador; Mr Murray Patterson, Fiji; Ms Grace Allen and Mrs Henry, Jamaica; Dr K. Baya and Dr E. Kamania, Kenya; Dr Hadida Bte Hashim, Malaysia; Mr P.S.P. Tembo and Mr W.C. Chalira, Malawi; Mr U. Myint Thein and Dr Maw Thein, Myanmar; Mr D.Gwillim and Mrs D. Tuka, Papua New Guinea; Dr S. Tennakoon and Mr Hsk Sirisena, Sri Lanka; Mr J.S. Muhume and Mr L.R. Mhangwa, Tanzania; Dr Iddir Kameleddine and Dr Jaleleddine Hila, Tunisia; Dr Mohamed Said Shaibani and Dr Hussein Al-Kataa, Yemen.

Analysis of the data and writing of the first draft report were done by Dr E. Somers, Dr Witold Wieniawski and Mr Eshetu Wondemagegnehu.

Comments received from countries, organizations and individuals were incorporated into the draft report by Mr Eshetu Wondemagegnehu who also finalised the report.

Mrs M. Helling-Borda and Mr Eshetu Wondemagegnehu were responsible for coordination of the study.

The study would have not been successfully completed without the cooperation and assistance of the drug regulatory authorities of both the importing and exporting countries and the WHO Regional Offices and the WHO Representative Offices of the countries involved in the assessment.

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