Importers in the EU will no longer have to obtain a written confirmation of compliance with EU GMP standards when importing active pharmaceutical ingredients (API) from Brazil and Israel. This is because Brazil and Israel were added to the list of countries considered to have GMP standards and controls equivalent to those of the EU[i].
According to EC Directive 2011/62/EU[ii], all active substances imported into the EU must be manufactured in compliance with standards which are at least equivalent to the EU GMP. As a result, since July of 2013, imports of API from non-EU countries (i.e., third countries) must be accompanied by a document providing written confirmation by the competent authority in the country of origin that the imported API was manufactured according to standards equivalent to the EU GMP.
The only exemption to rule requiring written confirmation of GMP compliance is API imported from third countries deemed to have manufacturing standards equivalent to those of the EU GMP. Until recently, only Australia, Japan, Switzerland and the United States were counted on this very short list of countries. As of July 1, 2015, Brazil and Israel were added to this list of countries so EU importers of API from Brazil and Israel have one less document to worry about.
Any questions regarding these changes may be directed to the trade compliance team.
Daniel J Bell
VP Regulatory Compliance & Technical Affairs 017 August, 2015