GMP clearance - Extension application processing timeframes

Recently we have received a number of enquiries from sponsors seeking an update in relation to the progress of their extension applications. In order to provide clarity around the internal triaging arrangements for processing extension applications, we can advise that we are currently aiming to process extension applications 2-3 weeks prior to expiry of the current clearance.

We continue to encourage sponsors to submit extension applications as early as possible in advance of their clearance expiry. Extension applications can be submitted through TGA Business Services (TBS) Portal up to 30 days past the current expiry date by maintaining your clearance as per Step 11 - Maintaining your active GMP clearance of the GMP clearance guidance.

Where sponsors have already submitted their extension application and have any concerns closer to the expiry date of their current clearance, please do not hesitate to contact GMP Clearance for an update.