Medicinal products within the meaning of this Act are medicinal products that are intended for administration to human beings. These comprise substances or preparations made from substances that:
1. are intended for use in or on the human body and are intended for use as remedies with properties for the curing, alleviating or preventing of human diseases or disease symptoms, or
2. can be used in or on the human body or can be administered to a human being, either:
a) to restore, correct or influence the physiological functions through a pharmacological, immunological or metabolic effect, or
b) to make a medical diagnosis. § 2 Abs. 1 AMG
Any substance or combination of substances
• presented as having properties for treating or preventing disease in human beings; or
• which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis [DIR 2001/83/EC Art 1(2)]. GVP Annex I - Definitions (Rev 5)