Article 1 of the Falsified Medicines Directive (FMD) requires all manufacturing authorisation holders to ensure that APIs meet the requirements of GMP. Member states likewise have a duty to ensure that all APIs manufactured on their territory meet GMP requirements.

Under Article 1(4) of the FMD a new Article 46b is inserted into Directive 2003/81. It is our understanding that the effect of this new Article is such that APIs may only be imported from a third country if one of the following conditions is met: