Written Confirmation: Australia gets on the List of "Third Countries"

Recommendation

4/5 February 2020
Prague, Czech Republic

Handling of Foreign Particles in APIs and Excipients

Starting from 2 July 2013, all APIs manufactured outside the EU have to be accompanied by a written confirmation issued by the monitoring authority in the exporting country confirming the GMP compliant manufacture of the APIs. This requirement doesn't apply to countries whose supervision and inspection systems have been recognised as equivalent to the EU standards. The countries which want to get such recognition have to submit a request to the EU Commission. After positive approval from the commission, the country in question gets on a list of "Third Countries" with comparable supervision systems to those existing in the EU.

Currently, only Switzerland is on that list (see our GMP News on the status report from the EU published on 17 April 2013). On 25 April 2013, the EU Commission announced its decision to put Australia on the list of "Third Countries".

Australia applied on 18 September 2012. Although there has existed an MR agreement since 1998, half a year was needed to give to the application a positive conclusion. Now the question is whether further countries (like Brazil and the USA) who have also applied to get on the list will get a positive response by 2 July 2013.

For further information please see the "Commission implementing decision in the Official Journal of the European Union".