WHO TRS (Technical Report Series) 1010, 2018 Annex 5


WHO TRS (Technical Report Series) 1010, 2018 Annex 5

WHO guidance on testing of “suspect” falsified medicines

1. Introduction:

1.1 “Suspect” medicines

“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.

1.2 Responsibility of regulatory authorities:

NRAs should establish rules and instruments that control the production, distribution and commercialization of medical products in order to ensure their quality through rigorous regulatory oversight, including postmarketing surveillance, in line with national legislation and regulations on pharmaceutical products. Rigorous regulatory oversight of medical products throughout their life cycle is necessary to recognize and remove unauthorized and/or falsified products and to protect the supply chain against infiltration of such products. 

Falsified medical products can originate from inside or outside the legal supply chain. It is important that NRAs secure the supply chain and raise awareness among health workers and patients of risks associated with medicines from illegal sources.

A legal definition of falsified medicines and specific legal provisions to penalize acts related to falsification of medicines will empower NRAs to take actions against this problem. In implementing and enforcing legal provisions on falsified medicines, NRAs should collaborate with customs, police, legislature, industry experts, judiciary, prosecutors and enforcement agencies at the national and international level as appropriate.

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Table of Contents

1. Introduction 

1.1 “Suspect” medicines 

1.2 Responsibility of regulatory authorities 

1.3 The role of the World Health Organization 

2. Scope 

3. Glossary 

4. Detection of suspect falsified products 

4.1 Entry points for detection 

4.2 Detection methods 

4.3 Selection of analytical techniques 

5. Sampling and documentation 

5.1 Sampling 

5.2 Documentation of information on suspect falsified medical products 

5.3 Chain of custody considerations 

6. Regulatory actions upon detection of suspect falsified medical products 

6.1 Risk assessment 

6.2 Questions to be answered by analytical testing 

6.3 Communication 

7. Confirmatory analytical testing 

7.1 Laboratory capacity 

7.2 Standard operating procedure 

7.3 Testing plan and test procedures 

7.4 Interpretation and reporting of results 

8 Reporting and regulatory action on confirmed falsified medical products 

9. Archiving of samples and reports 


Appendix 1 Examples of analytical techniques that may be used for package identification, screening and testing of suspect falsified medical products 

Appendix 2 Example of an information collection form

Appendix 3 Example of the content of a standard operating procedure for testing suspect falsified tablets 

Appendix 4 Examples of flowcharts for testing of suspect falsified medicines

WHO TRS (Technical Report Series) 1010, 2018 Annex 5:

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