Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products

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Download document Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products
Reference number EMA/CHMP/BWP/729106/2011
Status draft: consultation closed
First published 27/02/2012
Last updated 27/02/2012

Summary

In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product.