What are the streams and targets for product applications?
There are a number of different streams for product applications, the choice of which is dictated by the type of application and the data and/or information provided. Your application will be allocated to the appropriate stream following consideration at the weekly Registration Branch Applications Sift. Within each of the ’Admin’, ‘No-Data’, ‘Data’, ‘Data-Plus’ and ‘Major Change’ streams, we consider applications for commercial and experimental approval, Specific Off-Label Approvals (SOLA)/extensions of use and adjuvant authorisation.
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