Falsified medicinal product

Any medicinal product with a false representation of: (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used [DIR 2001/83/EC Art 1(33)].

This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights [DIR 2001/83/EC Art 1(33)].