Marketing authorisation dossiers for medicines: variations submitted as part of a PSUR: some clarifications

The template for submission of PSUR's (Periodic Safety Update Reports) and ASR's (Annual Safety Reports) annexed to the Circular 476 for the attention of the marketing authorisation holders of medicines and concerning the electronic submission of PSUR's and ASR's for medicines for human use, has been modified to attract the attention of the dossier managers when submitting a variation as part of a PSUR.

In order to manage the variations of the MA dossiers of medicines for human use in the context of a PSUR more easily, managers of these variations require the MA holders to consider the following points:

- When a change is submitted in parallel with the PSUR, it should be clearly stated on the "template for the e-submission of PSUR's / ASR's” of Circular 476 (in French), which was modified, including a section "Variation Submitted".

- When it is expected to submit a variation at a date later than the date of the submission of the PSUR (e.g. following the conclusions of its evaluation), it must be mentioned clearly in the "cover letter".
From now on the updated version of the template should be used and ensure the "cover letter" is completed.

Last updated on 22/01/2013