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 discussion3
Part 7 - Steps before Prequalification
Part 8 - Steps following marketing authorisation3
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.
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.
Additional product information "Blue Lady Package Design" - according to the supplier this information has been developed in collaboration with major International Family Planning Organisations for international family projects in developing countries and it is used/included in the pack when the product is distributed in developing countries. It should be noted that this information has neither been prequalified nor approved by the reference stringent regulatory authority (Germany).