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WHO Guidance on Testing of Suspect Falsified Medicines

Based on Annex 5, WHO guidance 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 guidance deals specifically with products that are suspected to belong to the third category, i.e. falsified medical products.

Suspect falsified products can be detected using a range of approaches, including routine inspections performed by national or regional authorities and enforcement agencies, targeted risk-based surveys, investigation of complaints, follow-up of reports on any suspicious observations in the supply chain (for example, inconsistent documentation or unexpected stock levels), discrepancy during verification and investigation of unexpected adverse events reported to have occurred with a specific product.

It is important to evaluate any information on suspect falsified products reported by customs, medicines inspectorates and other authorities, procurement agencies, wholesalers and importers, pharmacies, health-care institutions, patients and other stakeholders.

An information collection form, which is to be completed by the inspector or enforcement officer, should be comprehensive and include, but not be limited to:

– the point of detection in the supply chain (manufacturer, wholesaler, pharmacy, hospital or patient);

– the quantity of suspect product found;

– a visual description of its packaging;

– product name as marketed (if any);

– name of active substance (if known);

– the dosage units;

– the batch number;

– photographs;

– any signs of irregularities;

– the supply history of the product including the name, address of parties involved, date of transfer, etc.;

– a description of the circumstances leading to its detection (for example, adverse effects and any other relevant information).

This guidance should accompany the sample from the time it is taken until it is delivered to the testing laboratory.

Read also: List of WHO Guidelines for Pharmaceutical Industry

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