- All > Quality and Safety: Medicines > Counterfeit Medicines
- All > Quality and Safety: Medicines > Quality Assurance
- All > Quality and Safety: Medicines > Regulatory Support
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > analysis of drug samples
- Keywords > counterfeit pharmaceutical products - inspection guidance
- Keywords > drug testing
- Keywords > pharmaceuticals - falsified, counterfeit
- Keywords > quality control - lot testing
- Keywords > quality control – specifications and tests
- Keywords > sampling and testing - medicines
- Keywords > sampling procedure - pharmaceuticals
- Keywords > testing - suspect falsified medicines
- Keywords > tests, methods, and general requirements
(2018; 42 pages)
“Suspect” medicines can be divided into three main categories of products as follows:
(a) substandard medicines
Also called “out of specification”, these are authorized medicines that fail to meet either their quality standards or their specifications, or both.
(b) unregistered/unlicensed medicines
Medicines that have not undergone evaluation and/or approval by the national regulatory authority (NRA) for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation.
These medicines may or may not have obtained the relevant authorization from the NRA of their geographical origin.
(c) falsified medicines
Medicines that deliberately/fraudulently misrepresent their identity, composition or source.
Any consideration related to intellectual property rights does not fall within this definition.
Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration, reproduction of an authorized medicine or the manufacture of a medicine that is not an authorized product.
This document deals specifically with products that are suspected to belong to the third category, i.e. “falsified” medical products.
This is document provides technical guidance on laboratory testing of samples of suspect deliberately falsified medical products detected on the markets of WHO Member States and related aspects of sampling and reporting. This guidance should be read in conjunction with the guidelines on sampling and market surveillance.