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
Fermer ce répertoire7. SUMMARY ANALYSIS
Afficher le document7.1 Importing countries
Afficher le document7.2 Exporting countries
Afficher le document7.3 The WHO Certification Scheme
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
 

7.1 Importing countries

Analysis of data collected from the survey of 15 importing countries clearly shows that only two countries used the WHO Certification Scheme in drug registration in the format recommended by WHO. Eight countries requested national certificates, while the remaining five countries did not request any certificate since they do not have a system of drug registration.

Procurement data collected also revealed that, with the exception of one country, the rest requested different types of certificates during procurement. The certificates requested and their percentages were: WHO type certificates 27%; Certificate of Analysis 20%; Free Sale and Batch Certificate 27%; Free Sale Certificate 6%; GMP Certificate and Certificate of Quality Control 6%; and Registration Certificate 6%.

Confusion concerning the nature of a batch certificate (WHO-type) and of its difference from an analytical batch certificate issued by a manufacturer exists among the people working in drug registration and procurement. Analytical batch certificates issued by manufacturers are not usually linked to the certificate of a pharmaceutical product as recommended by WHO.

When questioned why they were not requesting the WHO-type certificates, most countries responded that they knew little about the Certification Scheme, its advantages and differences from the other certificates. Some said that the non mandatory nature of the Scheme did not encourage them to use it.

In general the majority of importing countries surveyed request certificates from exporting countries during registration and procurement. This indicates that there is high potential for the Scheme to be used by most of the importing countries, provided adequate information and promotional activities are undertaken.

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