New legislation was introduced on 2 January 2013 as part of Directive 2011/62 EU. This legislation will impact on most aspects of the pharmaceutical supply chain. There are implications for MA, WDL and MIA holders as well their excipient and active suppliers. Consideration will be given later to packaging.

The most immediate impact is for excipient and API manufacturers and suppliers with additional requirements for the application of GMP/GDP.

The MHRA have updates and further detail on their web site. Are you familiar with the requirements and do you have an action plan?