Written Confirmation: Japan on the List of "Third Countries"

Recommendation

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training
Contents of the regulatory information in the ASMF and CEP

As of 2 July 2013 each consignment of APIs to Europe must be accompanied by a written confirmation. Acoording to Article 111b of Directive 2001/83/EG, this requirement doesn´t apply to countries which - following prior verification - have been taken on a list of the European Commission.

According to an implementing decision published on 4 June 2013 in the Official Journal of the European Union, Japan has been put on the list of "Third Countries". The countries listed on it - so far Australia, Japan and Switzerland - have been recognised by the EU Commission as having an equivalent regulatory framework "applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union".

Japan is - beside the USA, India and China - a significant exporting country of APIs to the EU. Among the four countries mentioned, the USA is the only country which applied to be taken on the "Third Countries list". The application is currently being examined.