Update to Guidance document "Information on PSUR / PBRER submission"

Effective 1 April 2022, Swissmedic updated the Guidance document, allowing a transition period of 30 days.

The following points have been expanded on or clarified in section 5.2:

  • PSURs are generally submitted once a year as a 12-month report. It is possible to modify the submission cycle (e.g. submission every 6 months, submission every 2 years).
  • In future, modification of the reporting period will be via notification with brief supporting information (not an application as previously) by the marketing authorization holder to: This email address is being protected from spambots. You need JavaScript enabled to view it.
  • As a general rule, only one PSUR/PBRER document will be accepted per application.

Clarifications in section 5.4 regarding submission of RMP Updates have also been expanded on.

This guidance document enters into force on 1 April 2022 with a transitional period of 30 days.

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