9/10 February 2023
Since 2 July 2013, each API delivery from a non-EU country to the EU must be accompanied by a GMP compliance certificate ("Written Confirmation"). With this certificate the authority of the exporting country confirms that it has a control system to comply with GMP standards that is equivalent to the control system binding in the EU and that the exported batches of the API were manufactured according to these standards.
Article 111b of Directive 2001/83/EC allows an exemption, though: third countries can request a review of their systems for the monitoring and enforcement of GMP standards with the European Commission. If the review is positive the country is added on a "third countries list". This "third countries list" is part of an EU Commission Decision that is updated when further countries are added to the list. This decision usually becomes effective on the twentieth day following its publication in the official journal of the European Union.
The inclusion of Israel and Brazil in this list took place a few days ago with the release of the "COMMISSION IMPLEMENTING DECISION (EU) 2015 / 1057 of 1 July 2015 amending Implementing Decision 2012/715/EC of establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the included control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union".
More third countries - such as New Zealand and South Korea - have also asked for the exemption and are currently being reviewed, so that it can be expected that the list will be further extended in the near future.