TGA clarifies timelines on GMP clearances vs administrative changes

The TGA, Australia has provided clarification concerning timelines on GMP clearances vs administrative changes.

What is this about?

Recently TGA has experienced an increase in:

  • administrative change requests, either to change manufacturer name and minor address details or
  • transfer clearance requests between sponsors (i.e. transfer of sponsorship of GMP clearances)

This increase combined with the overall rise in applications received has resulted in the TGA prioritising assessments of GMP clearances over administrative changes.

What are the TGA expected timeframes to deal with the above requests?
Transfer of sponsorship of GMP Clearances
  • TGA aims to process simple transfer requests (less than five GMP Clearances) within 10 working days, where all documentation is provided, including full contact information of the new sponsor contact person.
  • Where larger transfer requests are submitted, TGA will take longer to action these requests.

Sponsors are asked to provide advice regarding proposed transfers as early as possible. Where a significant number of transfers are requested i.e. more than 30, sponsors are asked:

  • to identify which clearances are the most critical ones for transfer and
  • to provide an indication of timeframes when they will require the transfer to be completed to allow product regulatory actions to be undertaken.

TGA may need to seek additional time for large transfer requests and it may take several months for the transfers to be completed.

Name change applications (administrative changes)

Upon receipt of a name change application, name change is received, TGA is required to contact other sponsors before actioning the request.

This means that there are no set timeframes for actioning name changes as the time taken will vary depending on the number of sponsors involved and the number of ARTG entries to be updated.

Note that TGA is only able to update ARTG entries with current GMP Clearances. If your ARTG entry lists an expired GMP Clearance, you will need to request that this be updated through a product variation application.

Source: TGA website