GMP: Extension of Directive 2003/94/EC to GMP for APIs - EC Commission publishes Concept Paper for Comment

The EU Commission published a concept paper to extend Directive 2003/94/EC to GMP for APIs. This had already been announced in Directive 2011/62/EU on the prevention of the entry of falsified medicinal products into the legal supply chain published on 1st July 2011. According to this Directive, the Commission is obliged to adopt the principles of good manufacturing practice for APIs by means of a delegated act by 2013.