Rx-360 Understanding the Threat of Illicit Medicines: An Overview of Counterfeit, Tampered, Unapproved and Diverted Pharmaceuticals

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The distribution and sales of illicit products such as counterfeit, unapproved and diverted medicines are a global concern for pharmaceutical patients, health care professionals, regulators and manufacturers. Counterfeit drugs are not equivalent to the genuine product in safety, efficacy and quality. At best, they are of unknown composition and may be ineffective, and at worst harmful to patients. Unapproved medicines are drug products that have not been approved by a country’s health authority for product quality and efficacy or patient safety. Diverted drug products may be genuine but may not have the properties that doctors/pharmacists expect (if they are imported products) and may be subject to mishandling and inappropriate storage conditions that may impact product quality. They typically contain packaging and information leaflets in foreign languages for foreign markets that are not approved by the local health authority and are considered misbranded. This document provides a general overview of the definitions, sources, and distribution of illicit medicines in the finished form. This document is meant to provide a basic understanding but does not seek to provide detailed guidance.

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