The European Commission are proposing to extend the scope of Directive 2003/94/EC to cover active substances, including the manufacture of active substances. The intent is to bring cohesion of requirements for active substances and medicinal products. However, since all of the provisions for medicinal products would then also apply to active substances, there are significant implications, including requirements for document and records management.
A consultation process on the impact of this proposed change has now opened, with responses requested by 20 April 2012. Click HERE to download the concept paper.