TGA use only

This form, when completed, will be classified as 'For official use only'.
For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <

Notification: Transfer of sponsorship following transfer/assignment of business or interest in therapeutic goods[1]

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  • This form is to be completed by both the new sponsor and the former sponsor (Section 2 relates to the former sponsor). Do not submit the form until the transfer or assignment has occurred.
  • There is no fee required for this notification.
  • Please ensure you read Changes of sponsorship to therapeutic goods prior to completing and submitting this form.

Send completed forms to the TBS Helpdesk at:
Email: / Fax: 02 6232 8581
Post: TBS helpdesk, TGA, PO Box 100, Woden ACT 2606, Australia

Section 1 - Details of disposal, transfer, or assignment of,business/interest

Name of former sponsor:
(disposer)
Client ID:
Postal address:
Name of new sponsor: (acquirer)
Client ID: (if any)
Postal address:

List thetherapeuticgoodstransferred

If there are additional products, please add them as an attachment to the form.

ARTG number / ARTG product name / Therapeutic good type
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods
Choose a therapeutic good typeBiologicalsRegistered medicinesListed medicinesMedical devicesOther therapeutic goods

Section2 - Declaration of former sponsor

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  • Please note: Under section 137.1 of the Criminal Code Act 1995, it is an offence to knowingly provide information to a Commonwealth entity that is false or misleading in a material particular, or to omit any information without which the information is misleading in a material particular.
  • Penalty: 12 months imprisonment

I declare I am:

the former sponsor (transferor / assignor)
OR
authorised to make this declaration on behalf of the former sponsor

I declare that I / it,, have / has:

transferred / assigned the business in relation to the products listed in section 1 above, and have /agreed to transfer/ assign the registration/ listing/inclusionin the Register of those products
OR
transferred / assigned my/ its interest in the products listed in section 1 above, and have / has agreed to transfer / assign the registration / listing/ inclusionin the Register of those products

To(name of new sponsor):.

Date of transfer/ assignment:

I declare that the information I have provided above is true and correct.

Full name:
Position:* / Email:
Telephone: / Facsimile:
Signature / Date:

*e.g. managing director or regulatory affairs officer of former sponsor; agent of the former sponsor

Please note: In exceptional circumstances, if the declaration of the former sponsor is not provided in this form, the new sponsor will need to provide us with other documentary evidence that is sufficient to establish the transfer or assignment took place, including the date on which it occurred. Contact the TBS Helpdesk for information about the evidence to be provided.

Section 3 - Declaration of new sponsor

/
  • Please note: Under section 137.1 of the Criminal Code Act 1995, it is an offence to knowingly provide information to a Commonwealth entity that is false or misleading in a material particular, or to omit any information without which the information is misleading in a material particular.
  • Penalty: 12 months imprisonment

I declare I am:

the new sponsor (acquirer)
OR
authorised to make this declaration on behalf of the new sponsor

I declare that (the former sponsor)has:

transferred / assigned the business in relation to the products listed in section 1 above, and agreed to be transferred/ assigned the registration/ listing / inclusionin the Register of those products
OR
transferred / assigned its interest in the products listed in section 1 above, and has agreed to be transferred / assign the registration / listing /inclusion in the Register of those products

To (name of new sponsor):.

I declare that the information I have provided above is true and correct.

Full name:
Position:* / Email:
Telephone: / Facsimile:
Signature / Date:

*e.g. managing director or regulatory affairs officer of former sponsor; agent of the new sponsor

Please note:We may request more information before making the changes to the ARTG entries. We will usually update the relevant entries within 10 working days of receiving the notification.

Notification: Transfer of Sponsorship following transfer/assignment of business or interest in therapeutic goods
(August 2016)

For official use onlyPage 1 of 5

[1] See regulations 10AB (in relation to registered and listed therapeutic goods), 10F (in relation to medical devices) and 10H (in relation to biologicals).