Yоu аre required tо cоmpile the proposed Professionаl Informаtion for a new application for registration of a generic product. The product development was done in India, using the innovator product procured from the UK. The innovator product is no longer being marketed in South Africa under the original proprietary name, but as the company’s own generic product. There are several other generic products of the same active ingredient also registered, with the relevant PI and PIL available on the SAHPRA website in the PI repository. Explain how you will decide on the document to be used as the reference for your PI, with the justification that you will submit in your application to SAHPRA for the use of the selected reference.
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