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
Open this folder and view contents10. Regulatory issues
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
Close this folderAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
Close this folder1. General remarks
View the document1.1 Introduction
View the document1.2 Requirements and goals of the training programmes for inspection and examination
View the document1.3 Prerequisites
Open this folder and view contents2. Training programme for inspection
Open this folder and view contents3. Training programme on examination
View the documentReferences
View the documentWorld Health Assembly resolutions
View the documentAppendix 1 The practical issues of organizing and implementing the programme
View the documentAppendix 2 Thin-layer chromatography and its application
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

1.3 Prerequisites

The primary prerequisite for any programme combating pharmaceutical counterfeiting is the existence of an established drug regulatory authority in the country, which complies with the "Guiding principles for small national drug regulatory authorities" (1). That implies the availability of at least the following:

• A legal framework. The legislation is also expected to cover criminal activity in relation to the manufacture, import, distribution, sale and dispensing of counterfeit pharmaceuticals. The act of counterfeiting should be an offence such that the inspector of drugs, the police and other investigating agencies are all able to take action. The law should also provide for deterrent punishments.

 

• A system requiring:

 

(a) licensing/authorization of manufacturers, importers, distributors, retailers, pharmacies;
(b) registration/marketing authorization of drugs;
(c) proper labelling.

 

• Adequate professional staff and resources within the drug regulatory authority.

 

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