The TGA has published a notice advising that they are currently experiencing extremely high volumes of GMP Clearance extension applications which is resulting in delays to processing timeframes.

The TGA has advised that sponsors may experience instances where an extension application is only processed after the expiry date of their existing GMP Clearance.

Sponsors are encouraged to:

• Continue to submit extensions to your GMP Clearance where you meet the criteria to do so.

• Submit extension applications at least 1 month prior to the expiry date of your GMP Clearance.

• Only contact the GMP Clearance team if your expired GMP Clearance is affecting a regulatory submission to list, register or vary a product on the ARTG

If you need assistance with contacting the GMP Clearance team about your application, please contact us.