Transcription of Draft guideline on the sterilisation of the medicinal ...
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Draft guideline on the sterilisation of the medicinal ...
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2016 . Reproduction is authorised provided the source is acknowledged. 11 April 2016 1 EMA/CHMP/CVMP/QWP/BWP/850374/2015 2 Committee for medicinal Products for Human use (CHMP) 3 Committee for medicinal Products for Veterinary use (CVMP) 4 Quality Working Party (QWP) 5 Biologics Working Party (BWP) 6 guideline on the sterilisation of the medicinal product, 7 active substance, excipient and primary container 8 Draft 9 Draft agreed by QWP and BWP December 2015 Adopted by CHMP for release for consultation January 2016 Adopted by CVMP for release for consultation February 2016 Start of public consultation 13 April 2016 End of consultation (deadline for comments ) 13 October 2016 10 This guideline replaces Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98)
Adopted by CVMP for release for consultation ; February 2016 . Start of public consultation : 13 April 2016 . End of consultation (deadline for comments)
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