What legislation and guidance is relevant to the good manufacturing practice (GMP) of medicinal products?

Two directives laying down principles and guidelines of good manufacturing practice (GMP) for medicinal products were adopted by the Commission. Directive 2003/94/EC applies to medicinal products for human use and Directive 91/412/EEC for veterinary use.

Commentary on good manufacturing practice in accordance with UK and EU pharmaceutical regulation can be found at commentary: Good manufacturing practice: Halsbury's Laws of England. In particular, you may find the manufacturing of products section helpful which states that ‘The Good Manufacturing Practice Directive (Commission Directive (EC) 2003/94) lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. The principles and guidelines of good manufacturing practice for veterinary medicinal products are set out in a further directive’ (Commission Directive (EC) 1991/412 (OJ