Industry news

EU API Import Certification Template and Q&A;

On the 10th July 2012 the Commission release a “Template for the ‘written confirmation’ for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC”; i.e. a template for the declaration to be made by the competent authorities of non-EU countries exporting APIs. This template is published as part of EU GMP Part III.

At the same time the Commission published a Q&A document with the answers to 32 questions regarding the requirement for this written confirmation from the competent authority of the exporting third country. Amongst these questions and answers are the following clarifications:

• Each non-EU country can decide autonomously which body within that country issues the written confirmation. That non-EU country may decide to issue the written confirmation at central, regional or local level.
• The written confirmation is issued per manufacturing plant and the active substance(s) manufactured on this site.
• Each shipment must be accompanied by the appropriate certificate but this can be a copy of the original providing that it is still valid.

The Q&A document also gives the location of the list of countries who the Commission has approved and who will not require this certification. As of July 2012 the list shows that no countries are yet approved and just two countries, Israel and Switzerland, are in the process of being assessed.