Transcription of M4E(R2) - Common technical document for the registration ...
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M4E(R2) - Common technical document for the registration ...
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. 15 July 2016 EMA/CPMP/ICH/2887/1999 Committee for Human Medicinal Products M4E(R2) - Common technical document for the registration of pharmaceuticals for human use Efficacy Step 5 Transmission to CHMP August 2015 Adopted by CHMP for release for consultation 24 September 2015 Start of public consultation 7 October 2015 End of consultation (deadline for comments) 31 December 2015 Final adoption by CHMP 21 July 2016 Date for coming into effect 31 January 2017
M4E Questions & Answers posted on the web site M4E Q&As Approval by the Steering Committee of the newly added questions. 10 June 2004 M4E Q&As (R4) Current Step 2 version of the M4E(R2) M4E(R2) Approval by the Steering Committee under Step 2b and release for public consultation. Only the guideline for Sections 2.5.1 and 2.5.6 has been revised.
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