The Mutual Recognition And Decentralised Procedures
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CMD(h) BEST PRACTICE GUIDE ON THE …
www.hma.euBPG on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures Rev.5, November 2008 Page 1/11 CMD(h) BEST PRACTICE GUIDE
Quick Response (QR) codes in the labelling and/or …
www.salute.gov.itQuick Response (QR) codes in the labelling and/or package leaflet of centrally authorised veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised
All About Regulatory Affairs - Granzer
www.granzer.biz9 Application to first member state Assessment report including SPC, PIL First Authorization: RMS 210 days Applicant request on mutual recognition of first
Public Assessment Report Decentralised Procedure …
www.mhra.gov.ukPublic Assessment Report Decentralised Procedure Melphalan 50 mg Powder and Solvent for Solution for Injection/Infusion (Melphalan hydrochloride)
Commission Regulation (EU) No 712/2012 of 3 …
ec.europa.euCOMMISSION REGULATION (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of
Packaging ‘blue-box’ requirements and additional ...
www.hma.euCMDv GUI-027 _ addition CP EMA/CMDv/391895/2012 Page 1 of 35 . CMDv-GUI-27 . EMA/CMDv/391895/2012 . Version 22/12/2014 . Packaging ‘blue-box’ requirements and additional information on
ICH and EU regulatory framework and the role of …
www.ich.orgAlberto Ganan Jimenez, PhD –Quality of Medicines, European Medicines Agency (EMA) An agency of the European Union ICH and EU regulatory framework and the role of the European Medicines Agency (EMA)
QRD Human Product Information Template
www.ema.europa.eu2 - English language version: immediately after adoption of the opinion. - All other language versions: at the latest 25 days after adoption of the opinion (i.e. at the
eCTD Guidance Document - Europa
esubmission.ema.europa.euTechnical eCTD Guidance v3.0 Page 4 of 60 List of Tables Table 1: Example of an initial MAA in the Centralised Procedure.....11
NOTICE TO ASMF HOLDERS FOR ELECTRONIC …
ansm.sante.frANSM – 11/2017 Page 1 sur 6 www.ansm.sante.fr NOTICE TO ASMF HOLDERS FOR ELECTRONIC SUBMISSION OF ASMF TO ANSM VIA CESP ..... 2
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