PSUR repository mandatory in force as of June 13
Due to legal requirements (Reg. (EC) 726/2004, Article 25a), EMA is obliged to set up a database for periodic safety update reports (PSUR) and the associated 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 EMA will be available via the "PSUR repository").
- Instead of a quick change, EMA has proposed a phased implementation to allow national authorities and industry to gain experience with the system.
The phases of implementation are("Go-live" since January 26, 2015) are:
- Pilot phase (from January 26, 2015 - February 11, 2016).
During the pilot phase, PSUSAs (PSUR Single Assessment) were started to be processed at EMA and national authorities in parallel to the previous standard process via the repository.
- Switch-on phase (since February 11, 2016) From this point on, purely national procedures can now also be processed via the PSUR Repository.
- Use of the "PSUR Repository" will become mandatory for all PSUR submissions as of June 13, 2016. Companies will then no longer be required to submit PSURs to national authorities, but only through the PSUR Repository.
- The PSUR Repository provides a secure electronic submission point for marketing authorization holders that simplifies PSUR submission for the pharmaceutical industry. It will serve as a database for PSURs, opinions of PSURs, comments and results.
Summary
The "switch-on" phase started in February 2016, the circulation of opinions and comments, which used to be done by email, will now be carried out exclusively via the repository.
All marketing authorization holders are urged to submit their PSURs and supplements for nationally authorized products via the repository in addition to submission to the national authority to become familiar with the system. It should be noted that submission to the repository is already mandatory for centrally approved products.
The following points should be considered by the marketing authorization holder:
- Verify if there is a corporate process that needs to be adapted for the PSUR repository.
- Verify that access to available updates and guidance for use of the PSUR Repository and the "eSubmissions Gateway/Web Client" is provided in a timely manner prior to a planned submission through the Repository.
- Verify that all product details in the Article 57 database are correct prior to a planned submission.
- In addition to the submission via the PSUR repository, the marketing authorization holder for national products has to consider that the submission to the national authorities has to be continued in parallel until the system becomes mandatory to allow a controlled process.
Additional Information:
Regulatory holders are encouraged to report any problem encountered with the new system to the PSUR Repository mailbox: psurrepository@ema.europa.eu
For detailed information, the PSUR Repository website is available: http: //esubmission.ema.europa.eu/psur/psur_repository.html
