Industry news

Switzerland approved for API imports by EU

Switzerland has been listed as the first third country with standards in the manufacture of active pharmaceutical ingredients equivalent to those of the EU. After a successful assessment, the European Commission concluded that the regulatory framework applicable to active substances exported to the Union from Switzerland, the respective controls and the enforcement activities are equivalent to those of the Union. This means in practice that Switzerland will not have to issue a ‘written confirmation’ for each consignment of active substance for medicinal product for human use imported into the EU as of 2 July 2013.

Being listed by the European Commission or the issuing of a ‘written confirmation’ by a regulatory authority of the exporting country are two possible options introduced by the Falsified Medicines Directive to ascertain the quality of imported active substances.

Australia, Brazil, Israel and Singapore are the only other countries to have applied for listing yet. I would anticipate that Australia will be the next country to be listed as, like Switzerland, they adopt most EU GMP into their national standards and already have an active MRA with the EU.

So with one country on the Commission’s list and 30 countries in the EU/EEA, that only leaves around 165 other countries in the world who will need to set up a system for complying with EU GMP and issuing ‘written confirmation’ by 2 July 2013.