General Info on Licensing System
CMDv GUI-22 Format and number of copies for new marketing authorisation applications – updated with AT, RO, UK data and footnotes in March 2017
CMDv GUI-23 Format and number of copies in post-authorisation procedures – updated with footnotes in March 2017
CMDv GUI-25 Payment terms & addresses for national fees
Update April 2017 EL, NO, SE
Addresses for delivery and other contact points
Update April 2017 DE-BVL, EL, PL, SE, SK, UK
Guidance for Packaging ‘blue-box’ requirements and additional information on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures
clean version updated with DK, FI, FR, NO, RO, SE, UK data in May 2017
Guidance for Packaging ‘blue-box’ requirements and additional information on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures
track changes version updated with DK, FI, FR, NO, RO, SE, UK data in May 2017
CMDv GUI-31 Guidance for Marketing Authorisation Transfer – National Requirements – Update AT data February 2016
Member States' additional national requirements for submissions – updated with document number in March 2017
CMDv overview of Member States` requirements during national phase - updated with document number in March 2017