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New EU GMP directive

Belgium

The European Union (EU) has published its new directive for manufacturers of pharmaceutical products. This directive replaces the existing directive (Directive 2003/94/EC) on medicinal products for human use. The new EU Good Manufacturing Practice (GMP) directive, Commission Directive (EU) 2017/1572, came into effect on 31 March 2018. The new EU GMP Directive removes all aspects of the manufacturing of medicines for research which will make the Directive on finished products easier to read. The manufacturing of medicines for research will become subject to separate legislation, namely Regulation 2017/1569. The new EU GMP Directive has a similar structure as the existing one and many of the requirements remain the same.

This new EU GMP Directive was transposed into Belgian law via the Royal Decree of 27 June 2018, amending the RD of 14 December 2006.

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