Biological medicinal product

A medicinal product, the active substance of which is a biological substance [DIR 2001/83/EC, Annex 1, Part I, Section 3.2.1.1(b)].

A biological substance is a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control [DIR 2001/83/EC, Annex 1, Part I, Section 3.2.1.1(b)].