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Changes to the Part III of the EU GMP Guide

Friday the 15th July 2011

The EMA has added “Internationally harmonised requirements for batch certification” to Part III of the EU GMP Guide (see attached). This describes the content and format of the Batch Certification required to be issued by the manufacturer in the exporting country. This is relevant to those countries that have mutual recognition agreements with the EU: Australia, Canada, Israel, Japan, New Zealand and Switzerland.

The short document identifies the 17 requirements and provides explanatory notes and a glossary

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