Internationally Harmonized Requirements for Batch Certification

The requirements for batch certificate are stated in the document of European Medicines Agency (EMA) EMA/INS/MRA/387218/2011 Rev 5, entered into force 1 June 2011. The obligations for EU countries follow from Directive 2001/83/EC Art. 51.2, Chapter 6.17 document EudraLex – The Rules Governing Medicinal Products in the European Union Volume 4 and EU Guidelines to Good Manufacturing Practice.

Source: https://health.ec.europa.eu/system/files/2016-11/mra_batch-certificate_05-2011_0.pdf 

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