Industry news

EU leaflet on API imports

The EU has produced a leaflet to explain to outside countries the new legal requirements for certification when importing APIs into the EU, which become effective on 2 July 2013. Companies who currently purchase their APIs from outside of the EU can use this to communicate this requirement to their suppliers.

There is still great uncertainty as to whether the regulatory authorities in ‘third’ countries will be willing or able to provide the necessary certification and the potential impact that this will have on the supply of medicines in the EU.

India and China have indicated that they may together raise this matter with the World Trade Organisation (WTO) as it constitutes a technical barrier to trade. This move would indicate that they are both unlikely to be willing to co-operate with this new requirement to certify APIs (even if they could), so pharmaceutical companies are going to find themselves between a rock and a hard place. Given that a high percentage of the APIs used in European medicinal products come from India or China, this also has the potential to seriously threaten the availability of medicines in the EU.