IHS Chemical Week

EnviroTech :: Regulatory :: Regulatory: Legal

Switzerland first country listed under new rules, that can export APIs to EU without 'written confirmation'

4:22 AM MST | November 23, 2012 | Deepti Ramesh

The European Commission says that Switzerland has on 22 November been listed as the first non European Union (EU) country with active pharmaceutical ingredient (API) manufacturing standards equivalent to those of the EU.  The EU has reformed the rules for importing into the EU APIs for medicinal products for human use. As of 2 January 2013, all imported APIs must have been manufactured in compliance with good manufacturing practice (GMP) standards equivalent to the GMP of the EU. Being listed by the European Commission or issuing a 'written confirmation' are...

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