Periodic Safety Update Report (PSUR) submissions shall be submitted directly to EMA as of June 13, 2016

Wednesday, June 01, 2016

As of June 13, it is mandatory for Market Authorizing Holders (MAH) in Sweden to submit PSUR directly to the PSUR Repository database at the EMA.

It is essential that all MAHs, who have not previously used the eSubmission Gateway / Web Client, should register to use the submission tools as soon as possible.



Please note the news item’s date of publishing. The Swedish Medical Products Agency does not update news.


Related information


Contact us

Karl Mikael Kälkner
Expert at the Swedish Medical Products Agency
Tel: +46 18 17 46 00

Johan Aulin
Section Manager, Regulatory administration
Tel: +46 17 42 08

Hanna Norek
Regulatory Manager and National contact point for PSUR Repository
Tel: +46 18 17 42 68


Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | | Contact information