WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Close this folder10. Regulatory issues
Close this folder10.1 WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the document10.1.1 Finished pharmaceutical products
View the document10.1.2 Active pharmaceutical ingredients
View the document10.2 WHO model system for computer-assisted drug registration
View the document10.3 Model guidelines for the international provision of controlled medicines for emergency medical care
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover

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.


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