New rules on importing APIs into the EU

Published: 19-Oct-2012
Ingredients Regulatory

From 2 January 2013, all imported active substances must have been manufactured to GMP standards


The European Commission has published an information leaflet regarding the newly reformed rules for importing active ingredients for medicinal products for human use into the EU.

As of 2 January next year, all imported active substances must have been manufactured in compliance with standards of good manufacturing practices (GMP) at least equivalent to the GMP of the EU. The manufacturing standards in the EU for active substances are those of the ‘International Conference for Harmonisation’ – ICH Q7.

As of 2 July 2013, this compliance must be confirmed in writing by the competent authority of the exporting country.

The EU has compiled a template for the written confirmation, which must be attached to the active substance being imported into the European Union, and this is contained in the information leaflet.

This document must also confirm that the plant where the active substance was manufactured is subject to control and enforcement of good manufacturing practices at least equivalent to that of the EU.

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