(1995; 156 pages)
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.