Thursday, 21 January 2021 14.00 - 15.30 h
GMP News No. 549
Regulatory Affairs
News
25 April 2005 |
Summary of Changes in the Notice to Applicants |
We would like to inform you about the latest updates of the Notice to Applicants. Please find a summarisation of these latest updates with hyperlinks to the revised documents - listed in the order of the Volumes mentioned below: Notice to Applicants Volume 2A Chapter 7: General
Information (March 2005) Main changes:
Notice to Applicants Volume 2B: Presentation and content of the dossier Part 1: Summary of the dossier
Part 1A User Guide for the Application Form (March 2005) Main changes:
Summarisation of latest updates of some Notice to Applicants (listed in the order of the Volumes) cont'd: Notice to Applicants Volume 2C and 6C : Application Form
for renewal of a marketing authorisation (March 2005) Main changes:
Notice to Applicants Volume 2C: Guideline on the Packaging
Information of Human Medicinal Products authorised by the Community (March
2005) Main changes:
If you are interested in special Regulatory Affairs events, please allow us to recommend the following conferences or eduction courses:
|
|