Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - Patient information leaflet, as approved by the reference authority1,2
Part 4 - Summary of product characteristics, as approved by the reference authority1,2
Part 5 - Labelling, as approved by the reference authority1,2
Part 6 - Scientific discussion3
Part 7 - Steps before Prequalification
Part 8 - Steps following marketing authorisation3
For this type of product WHO recommends different or additional uses: Clinical and preclinical information on these uses are available for the health care provider and for the patient . Moreover, 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 the WHOPAR part 1. If not, the documents are included, if necessary, as certified English translation.
2 Information on the WHO-recommended uses for medicines with these APIs may be included as supplemental information (see link in the above paragraph).
3 These parts are 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 part 1.