What are the expectations with regard to using data on file?

Claims, comparisons, etc. must be capable of substantiation and such substantiation must be provided as required by Clauses 6.2, 14.3 and 18.2.

When reviewing data on file, companies should be confident it is consistent with the summary of product characteristics. There is an expectation that the results are not dissimilar to those in the registration trials. Care needs to be taken to ensure the data on file meets all other requirements of the Code including Clauses 6, 14 and 18 as applicable.