基于风险评估建立暴露限度.pdf

20 November 2014 EMA/CHMP/ CVMP/ SWP/169430/2012 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities Draft Agreed by Safety Working Party December 2012 Adoption by CVMP for release for consultation November 2012 Adoption by CHMP for release for consultation 13 December 2012 End of consultation (deadline for comments) 30 June 2013 Adoption by CVMP 11 September 2014 Adopted by Safety Working Party October 2014 Adoption by CHMP 20 November 2014 Date for coming into effect 01 June 2015 Keywords Shared facilities, risk identification, exposure limits, toxicological data, residual active substances, PDE. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities Table of contents Executive summary 3 1. Introduction (background) 3 2. Scope 3 3.