EMEA: API Export Written Communication

On 10 July 2012, the European Commission published the final 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.


The new template is now the fifth document which has been published under Part 3 of the EU GMP Guide. Part 1 contains GMP for Medicinal Products, Part 2 GMP for APIs and Part 3 contains additional requirements for Site Master Files, Quality Risk Management (ICH Q9), Quality Systems (ICH Q10) and the MRA Batch certificate.