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Chapter 1 - Pharmaceutical Quality System (into operation since 31 January 2013).Part I - Basic Requirements for Medicinal Products Commission Directive (EU) 2017/1572 (for linguistic versions, click here) of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials).Commission Delegated Regulation (EU) 2017/1569 (for linguistic versions, click here) of supplementing Regulation (EU) 536/2014 of the European Parliament and of the Council by specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials).Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.

Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.

Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.

Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.