Transcription of Q12 Step 2b Technical and regulatory …
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Q12 Step 2b Technical and regulatory …
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, 2017. Reproduction is authorised provided the source is acknowledged. 14 December 2017 1 EMA/CHMP/ICH/804273/2017 2 Committee for Medicinal Products for Human Use 3 ICH guideline Q12 on Technical and regulatory 4 considerations for pharmaceutical product lifecycle 5 management 6 Step 2b 7 Transmission to CHMP 14 December 2017 Adoption by CHMP for release for consultation 14 December 2017 Start of consultation 18 December 2017 End of consultation (deadline for comments) 18 December 2018 8 9 Comments should be provided using this template.
ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
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