(1999; 168 pages) [Spanish]
10.1.1 Finished pharmaceutical products
The Committee was informed that the guidelines on the scheme relating to pharmaceutical dosage forms, as published in its thirty-fourth report (14), were endorsed in Resolution EB99.R21 at the 99th session of the Executive Board in January 1997, and transmitted to the 50th World Health Assembly for adoption.1 The resolution urges Member States to implement the guidelines. Thus, importing countries should request and exporting countries should issue WHO-type product certificates as from 1 January 1998. The Committee was also informed about discussions on the scheme during the eighth International Conference of Drug Regulatory Authorities held in Bahrain in 1996. The reports given at the conference demonstrated that the use of the scheme was steadily increasing and that some regulatory authorities, including the European Medicines Evaluation Agency, were already issuing WHO-type product certificates in the revised format as published in the thirty-fourth report (14).
1 Subsequently adopted as WHA50.3, May 1997.