Guidelines and Codes
Biostudy Reference Products
Added to web site: July 2006
As a result of feedback from Industry Stakeholders, Medsafe wishes to advise that in future the Evaluation Team will accept biostudies generated against the Australian reference product. This will come into effect from 7 July 2006. Please note that where the Australian reference product cannot be established as being marketed in NZ the generic medicine’s datasheet must include the following statement, or words of similar meaning: “This product may not be interchangeable with similar products on the New Zealand market”.