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 Medical Products Agency does not update news.