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GMP clearance guidance

Version 18.1, January 2019

4 January 2019

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Transferring your GMP Clearance

If products on the ARTG are transferred between sponsors, the associated existing active GMP clearances may need to be transferred as well.

The new sponsor must contact and provide:

  • the details of all affected clearances to be transferred
  • a letter from the transferring sponsor indicating assent to the GMP clearance transfers; a copy of any sale/transfer agreement may also be acceptable
  • current details (Client ID number, contact information).

The new sponsor needs to have a GMP, quality or technical agreement with each manufacturer with whom they have a direct relationship (this may be requested).

  • Expired GMP clearances cannot be transferred. A new application needs to be submitted by the new sponsor.

Clearances currently under assessment that have had a transfer of sponsorship processed will not be viewable by the new sponsor until the application has been issued.

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