Submission of Periodic Safety Update Reports (PSURs)
The European Medicines Agency has published the list of European Union (EU) reference dates and frequency of submission of periodic safety update reports (PSURs) known as the 'EURD list'.
Due to legal provisions (Reg. (EC) 726/2004, Article 25a), the EMA is obliged to set up a database for periodic safety update reports (PSUR) and the associated expert opinions.
- All PSUR procedures must be submitted electronically (according to Reg. 726/2004, Article 107b paragraph 1 and Article 28(2)).
- Since September 1, 2015, the use of the xml file for PSUR submission is mandatory (all PSURs submitted to the EMA will be available through the "PSUR repository").
- The EMA has proposed a phased implementation rather than a rapid change to allow national authorities and industry to gain experience with the system.
The phases of implementation are ("go-live" since 26 January 2015):
- Pilot phase (26 January 2015 - 11 February 2016)
During the pilot phase, PSUSAs (PSUR Single Assessment) at the EMA and the national authorities were started to be processed via the repository parallel to the previous standard process.
- Switch-on phase (since 11 February 2016)
From this point on, purely national procedures can also be processed using the PSUR Repository.
- The use of the "PSUR Repository" will be mandatory for all PSUR submissions as of June 13, 2016. Companies then no longer have to submit PSURs to national authorities, but only via the PSUR repository.
- The PSUR Repository is a secure electronic submission point for marketing authorisation holders that simplifies PSUR submission for the pharmaceutical industry. It will serve as a database for PSURs, PSUR reports, comments and results.
The "switch-on" phase began in February 2016, and the circulation of reviews and comments, which used to be via email, will now be done exclusively through the repository.
All marketing authorisation holders are urged to submit their PSURs and supplements for nationally authorised products via the repository in addition to submitting them to the national authority in order to become familiar with the system. It should be noted that submission to the repository for centrally approved products is already mandatory.
The following points must be considered by the marketing authorisation holder:
- Check if there is a business process that needs to be adapted for the PSUR repository.
- Verify that access to available updates and instructions for using the PSUR repository and the eSubmissions Gateway/Web Client is provided in a timely manner prior to any scheduled submission via the repository.
- Check that all product information in the "Article 57 database" is correct before a planned submission.
- In addition to submission via the PSUR repository, the marketing authorisation holder for national products must bear in mind that submission to the national authorities must continue in parallel until the system becomes mandatory in order to allow a controlled process.
Marketing authorisation holders are requested to report any problem that occurs with the new system to the PSUR Repository mailbox: psurrepository @ema.europa .eu
The PSUR Repository website is available for detailed information.
took place on 30.05.2016 at Traisengasse 5 1200 Vienna.
The mandatory PSUR repository submission starts on 13 June 2016.
On this occasion the AGES Medizinmarktaufsicht informed about news regarding PSURs/PSUSAs and details of the submission during a short AGES meeting.
Answers to the questions raised by industry in the course of this discussion were published in FAQ 1.1.
The lectures can be read here: