On 20 July 2018, the Royal Decree of 27 June 2018, which implements Commission Directive 2017/1572 as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (GMP Directive), was published. The decree should have been implemented on 31 March 2018, when the GMP Directive entered into force.

While the GMP Directive has an almost identical structure to its predecessor, Directive 2003/94/EC, it no longer contains any provisions on the manufacturing of medicines for research, which will be included in separate EU legislation to enhance readability.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, August 2018 Issue (Thomson Reuters).