Preliminary Assessment Report
- Guideline or reference source
- HMA website
- Definition
- The reference member state forwards the Preliminary Assessment Report (PrAR) (including comments on SPC, package leaflet and labelling) on the dossier to the concerned member state and the applicant within 70 days after the start of the procedure. This PrAR will include a comment on whether ‘user consultation’ of the package leaflet has been performed or is foreseen, or the justification for its absence is acceptable. The reference member state will have the main responsibility for the assessment of the package leaflet.
- Abbreviation for
- PrAR
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