An NSF International Company USA added to EC list of approved exporting countries
Monday the 24th June 2013
On Friday 21 June the European Commission announced that the USA had been added to the list of countries who are exempt from the need to issue Good Manufacturing Practice Certificates for APIs from that country (the so-called ‘White List’). This means that Switzerland, Australia, Japan and the USA are now on this list.
The USA has approximately 15% of the API sites exporting to the EU so this is by far the most significant addition to the list of approved countries; especially as the FDA said that, for legal reasons, they would not be able provide the API GMP certification required by the Falsified Medicines Directive.
