• By ICR Secretariat
  • Posted Thursday, September 28, 2017

New EU GMP Legislation published


The European Commission has published new GMP legislation in the Official Journal of the EU. Directive 2017/1572 covers GMP for marketed products and delegated Regulation 2017/1569 covers GMP and inspections for investigational medicinal products (IMPs). As a consequence the current EU GMP Directive 2003/94/EC will be repealed.

Directive 2017/1572 on marketed product GMP has to be transposed into Member State’s national law by 31 March 2018 and together with IMP GMP Regulation2017/1569 will come into force on 1 April 2018. The current GMP Directive 2003/94 will be repealed on the same date.

The new Directive and Regulation can be found on the NSF Pharma App and Peter Gough will cover these and other changes in his Pharmaceutical Legislation update on 3 October; see http://www.nsf.org/training-education/training-entry/1864074-pharmaceutical-legislation-update for details.