Revision 3 of GVP Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies

The revisions to GVP Module VIII are as follows:

1. In section VIII. Add.I.2., deletion of a paragraph describing the notification procedure from EMA to Member States of the public registration of a post-authorisation study requested by a competent authority conducted on theirterritory andfundedby a marketing authorisation holder (this notification procedure was previously performed on a monthly basis and has now been discontinued following the modification of the search function of the EU PAS Register allowing searches by country);
2. In section VIII. Add.I.3., amendment of the list of national competent authorities not requiring progress reports for non-interventional PASS imposed as an obligation, i.e. addition of Finland and Norway

Revision 3 of GVP Module VIII was effective on 24 June 2020.

Review the updated version of GVP Module VIII…