(1995; 156 pages)
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.