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GMP MANUAL
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Question of the Week

Do you know examples for criteria that can be considered in the risk assessment for counterfeit medicines?

Criteria for risk assessment for counterfeit medicines

Economic considerations:
- price-turnover factor as an impetus for counterfeiters
- impact on manufacturers if counterfeits occur
- incentives for consumers to circumvent the usual distribution chain

Properties of the medicinal product
- route of administration of the medicinal product
- possible consequences of using a counterfeit
- probability of discovery during use
- degree of complexity of production

Other indicators:
- internal historical data on the product / comparable products
- external data on comparable products- distribution routes

[GMP MANUAL, Chapter 19.I.4]

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