(1997; 248 pages) [French]
3.1 General considerations
Although countries vary in their resources and priorities, advantage accrues from harmonizing documentary requirements to the fullest possible extent, since this simplifies registration procedures and reduces costs.
The most important starting-point for imported products is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.1 This gives basic information on composition, an assurance that the product is manufactured in accordance with good manufacturing practices in premises subject to inspection, and information on the regulatory status of the product in the country of export. A certificate, issued in compliance with the model format recommended by WHO, should be required whenever application is made to license an imported product.
1WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-first Report. Geneva, World Health Organization, 1990 (WHO Technical Report Series, No. 790), Annex 5.