Document details
| 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.