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EMA seeks feedback on non-EU API import confirmation letter

18-Apr-2012

The EMA is seeking industry comments on its draft template for written confirmation of API imports from outside Europe.

Publication of the draft follows adoption of the falsified medicines directive. The directive says firms should only import APIs (active pharmaceutical ingredients) from overseas after the regulator in the country of manufacture sends written confirmation that the plant meets European Union standards.

To help firms gain confirmation the European Medicines Agency (EMA) has posted a draft template showing what information is needed. Companies have until June 1 to comment on the template.

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