Periodic Safety Update Reports Periodic Safety Update Reports

1. 191Obligation on holder to submit periodic safety update reports: general requirements
2. 191AObligation on holder of a parallel import licence to submit periodic safety update reports
3. 192Obligation on holder to submit periodic safety update reports: derogation from general requirements
4. 193Harmonisation of PSUR frequency or date of submission
5. 194Responding to a single assessment of PSUR under Article 107e of the 2001 Directive
6. 195Obligation on licensing authority to assess PSURs ...