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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) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoACKNOWLEDGMENTS
Ver el documentoPREFACE
Ver el documentoEXECUTIVE SUMMARY
Abrir esta carpeta y ver su contenido1. INTRODUCTION
Ver el documento2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Ver el documento3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Abrir esta carpeta y ver su contenido4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Abrir esta carpeta y ver su contenido5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Ver el documento6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Abrir esta carpeta y ver su contenido7. SUMMARY ANALYSIS
Ver el documento8. CONCLUSIONS
Ver el documentoANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Ver el documentoANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Ver el documentoANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Ver el documentoANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Ver el documentoANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Ver el documentoANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Ver el documentoANNEX 4 (b): Certificate of a Pharmaceutical Product
Ver el documentoANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Ver el documentoANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Ver el documentoANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Ver el documentoANNEX 6: List of Participants in the Study
Ver el documentoANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Ver el documentoANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Ver el documentoANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Abrir esta carpeta y ver su contenidoANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Ver el documentoBACK 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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