Document details
| Download document | Draft guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities |
|---|---|
| Reference number | EMA/CHMP/CVMP/SWP/169430/2012 |
| Status | draft: consultation open |
| First published | 08/01/2013 |
| Last updated | 08/01/2013 |
| Consultation start date | 08/01/2013 |
| Consultation end date | 30/06/2013 |
| Email address for submissions | swp-h@ema.europa.eu |
Summary
The scope of this guideline is to ensure the safety of human patients and target animals exposed to residual active substances via medicinal products as well as consumers potentially exposed to residual active substances in products derived from treated food-producing animals. This document should be read in conjunction with corresponding GMP guidance in Chapters 3 and 5 of the GMP Guide published for consultation by the European Commission and can be found at: http://ec.europa.eu/health/files/gmp/gmp_chapter3_en.doc http://ec.europa.eu/health/files/gmp/gmp_chapter5_en.doc