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.