Falsified Medicinal Product

A Falsified Medicinal Product pertains to any medicine characterized by a fraudulent representation in terms of (a) its identity, encompassing packaging, labeling, name, or ingredient composition, including excipients and their strengths; (b) its origin, involving manufacturer, country of manufacturing, country of origin, or marketing authorization holder; or (c) its historical information, involving records and documents concerning distribution channels employed.

It’s important to note that this definition excludes unintended quality defects and does not prejudice violations of intellectual property rights. Falsified medicinal products are intentionally deceptive, with the intention to mislead by either misrepresenting their identity, composition, or source. These medicines often mimic genuine products in appearance but might contain components of inferior or hazardous quality or incorrect dosages, posing significant risks to patients’ well-being.