Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - Patient information leaflet, as approved by the reference authority1
Part 4 - Summary of product characteristics, as approved by the reference authority1
Part 5 - Labelling, as approved by the reference authority1
Part 6 - Scientific discussion2
Part 7 - Steps before Prequalification
Part 8 - Steps following marketing authorisation2
The medicine may be authorised for additional or different uses by national medicines regulatory authorities.
1 If the SRA approved PIL, SmPC and/or labelling, or equivalents thereof, are available in English on the reference SRA website, a link is included in WHOPAR part 1. If not, the documents are included, if necessary, as certified English translation.
2 This part is not available for all products prequalified via the abridged route. If a public assessment report is available and contains this information, a weblink is included in WHOPAR part 1.