(1997; 248 pages) [French]
World Health Assembly resolution WHA50.3: Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
The Fiftieth 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 resolutions WHA45.29 and WHA49.14;
Having reviewed the revised guidelines on implementation of the Certification Scheme which are the result of field trials in a number of WHO Member States and discussions during the sixth and seventh biennial International Conferences of Drug Regulatory Authorities;1
1 WHO Technical Report Series, No. 863, 1996, Annex 10.
Believing that the adoption of the revised guidelines will provide an important instrument in support of drug registration in the importing country by ensuring access to transparent information on the regulatory status of the pharmaceutical product in the exporting country and the true origin of products to be imported,
1. ENDORSES the guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce and model certification forms annexed to the guidelines;
2. URGES Member States:
(1) to implement these guidelines, to request WHO-type certificates in the form contained in the guidelines and to issue the certificates in the form proposed, as from 1 January 1998;
(2) to inform the Director-General of their intent to apply the Scheme and of any significant reservations they intend to express relating to their participation as provided for in article 2.1 of the guidelines.