In discussions over the development of the falsified medicines directive (Directive 2011/62/EU) there has been wide-ranging debate around the safety provisions requirements of tamper evidence and unique pack identification but perhaps not so much publicity has been given to the provisions relating to increased control over the quality of active pharmaceutical ingredients (APIs).
In particular, there are significant new requirements in relation to importation of APIs from third countries. The Directive requires that imported material is accompanied by a certificate from the exporting third country confirming that standards of GMP at the plant are at least equivalent to those of EU GMP requirements for APIs, that the plant is subject to regular inspection and that findings of non-compliance are reported to the EU authorities.
Alternatively, an API may be imported from a third country without certification if it is imported from a list of countries verified by the EU as meeting requirements for GMP for APIs. Finally, and in exceptional circumstances, an API may be imported from a third country plant that has been subject to an inspection by an EU authority and found to be compliant.
With a deadline for the implementation of these provisions of 2 July 2013 there is concern at the lack of clarity as to how the mechanisms for implementation within that time frame will be put in place by the European Commission. There is particular concern in relation to major API exporting countries such as India and China. There will obviously be much activity over the coming months to seek a resolution to these problems.