Search results with tag "Worksharing"
Type II variation and worksharing assessment timetables
www.ema.europa.euThe choice of the assessment timetable for a type II variation or worksharing procedure depends on the nature of the change(s) applied for. Type II variation assessment timetables for non-ATMPs1 follow either a monthly or a weekly periodicity start. Monthly timetables start once a month and conclude during the week of the CHMP plenary meeting.
Timetable: Type II variation and worksharing application ...
www.ema.europa.euType II variation and worksharing application : monthly * assessment timetables: Initial submission assessment timetable: Responses to Request for Supplementary Information (RSI) assessment timetable * monthly timetables have an outcome during the week of the CHMP meeting 30-day after clockstop
CMDv/BPG/018 BEST PRACTICE GUIDE for Worksharing …
www.hma.eu3.1 Regulation 1234/2008 . of 24 November 2008 as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 . concerning the examination of …
Tarceva - European Medicines Agency
www.ema.europa.eu1 Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II va riation or extension application or a worksharing application).
Public Service Pension Reform: Revised ill-health and ...
circulars.gov.ie5 APPENDIX 1: EXAMPLES OF CALCULATIONS OF ILL-HEALTH ENTITLEMENTS EXAMPLE 1 : Age 56 Worksharing pattern 60%