2The third subparagraph of point 3.2.1.1 (b) of Part I of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive (EU) 2022/642 of the European Parliament and of the Council of 12 April 2022 (OJ 2022 L 118, p. 4) (‘Directive 2001/83’), states that a ‘biological medicinal product is a product, the active substance of which is a biological substance’.