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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) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Ouvrir ce répertoire et afficher son contenuANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Afficher le documentBACK COVER
 

ANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

WHA45.29 The Forty-fifth World Health Assembly,

Taking note of previous resolutions on WHO's Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce, and particularly resolution WHA41.16, which refers to the export, import and smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical operations;

Having reviewed the report on the implementation of WHO's revised drug strategy, and in particular the proposed guidelines on the implementation of the Certification Scheme;

Aware of the need for prospective importing countries to obtain explicit assurances regarding the quality of products not registered in the country of provenance;

Believing that adoption of the proposed guidelines will contribute to deterrence of the export, import and smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations;

Recognizing that a comprehensive system of quality assurance including the WHO Certification Scheme must be founded on a reliable national system of licensing, independent analysis of the finished product and independent inspection to verify that all manufacturing operations are carried out in conformity with accepted norms, referred to as "good manufacturing practices";.

1. ENDORSES the guidelines for implementation of the WHO Certification Scheme, which will be evaluated and revised, as necessary, in consultation with the Committee on Drug Policies of the Executive Board;

2. URGES Member States to implement these guidelines, and to issue certificates within five years in a form to be agreed in the light of experience gained in preliminary field testing.

May 1992

 

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