Messages in brief

News

Save the date

messages in brief |

BASG-Dialogue "Quality Day" on 29 May 2018 and 13 June 2018


During this event you will hear a lot about relevant documentation in
Module 3.…
Save the date Read more
News

Templates and User-Guide for creation of Accessible Package Leaflets

messages in brief |
As pubished an 29.06.2018 the Federal Office for Safety in Health Care (BASG), was obliged in an arbitration process according to § 14 of the Federal…
Templates and User-Guide for creation of Accessible Package Leaflets Read more
News

eCTD/VNeeS will also be mandatory for purely national lifecycle applications

messages in brief |
According to eSubmission-Roadmap purely national variation and renewal applications have to be submitted mandatorily in eCTD/VNeeS format after…
eCTD/VNeeS will also be mandatory for purely national lifecycle applications Read more
News

EMA EudraVigilance Umstellungsphase

messages in brief |
Following the EMA Management Board confirmation and announcement in May 2017 that the database has achieved full functionality, the new version of Eud…
EMA EudraVigilance Umstellungsphase Read more
News

eCTD/VNeeS will be mandatory for national applications

messages in brief |
In February 2017 an updated version of the eSubmission-Roadmap was published, setting implementation dates for mandatory use of eCTD/VNeeS format in…
eCTD/VNeeS will be mandatory for national applications Read more
Email

Further inquiry note