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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
 

ANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly

WHO CERTIFICATION SCHEME ON THE QUALITY OF PHARMACEUTICAL PRODUCTS MOVING IN INTERNATIONAL COMMERCE

WHA41.18 The Forty-first World Health Assembly,

Taking note of previous resolutions on the question;

Having examined the Director-General's report on the rational use of drugs, and in particular the proposed amendments to the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce;

Noting the fact that, in any case of obvious doubt, any Member State may request the Organization for assistance in finding an independent collaborating centre to carry out batch tests for the purposes of quality control;

1. ADOPTS the revised text of the expanded WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce; 1


1 Document WHA41/1988/REC/1, p.53.

2. INVITES Member States which are not yet participating in the Scheme to do so;

3. RECOMMENDS to Member States that they implement as far as possible all the provisions of the expanded WHO Certification Scheme;

4. REQUESTS the Director-General to report, in his report on WHO's revised drug strategy to a future Health Assembly, on the progress accomplished in the implementation of the expanded WHO Certification Scheme.

May 1988

 

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