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Changing the sponsor of therapeutic goods

11 July 2019

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Frequently asked questions

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  1. Submit Manufacturer Evidence application as per the standard process.
  2. Once the evidence has been accepted submit a change request application to have the evidence linked to the ARTG entry or entries. Please refer to the Varying entries in the ARTG - medical devices and IVDs document for more information.

No.

Under the Therapeutic Goods Regulations, the obligation to notify us happens after the relevant event has occurred.

We will only process notification forms or other notifications of a transfer etc. that:

  • have been provided to us after the event; and
  • indicate that the event has already occurred.

No.

Regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations set out the circumstances where a person is taken to be the new sponsor.

This is not affected by whether the products covered by the relevant entries are or are not compliant with regulatory requirements. If goods supplied by any sponsor are not compliant (for instance with labelling standards that apply under the Therapeutic Goods Act) or a sponsor is not complying with conditions or other regulatory requirements in relation to the goods (for instance, does not respond to a request to provide information about the goods), we may take regulatory action.

The notification forms ask the new sponsor to provide its Client ID (if any).

If you are a new sponsor and do not have a Client ID, make an application by completing the Organisation details form, which can be found at: Organisation details.

New sponsors who contact us will be advised of the process for applying for a new Client ID, and other available options, such as completing a paper-based form.

For sponsors without eBS access, information is available on our website at TGA Business services: getting started with the TGA.

It may be an offence under the Therapeutic Goods Act for the former sponsor to supply therapeutic goods once a sponsor transfer has taken place, even though the product was in stock when the transfer became effective.

This is because the disposal of the business resulted in the new owner becoming the person legally responsible for the goods in the ARTG, even if we have not been notified of the transfer and/or the ARTG entry has not been updated.

The change of sponsorship occurs by operation of law, i.e. it is triggered by the one of events referred to in regulations 10AB, 10F and 10H, and not by the TGA updating the ARTG entries after we have been notified.

The new owner (new sponsor) does not commit an offence by supplying the goods.

Relevant offences in the Act

Supplying therapeutic goods (that are not biologicals or medical devices) such as medicines, that you have imported, or that have been manufactured on your behalf, when you are not the sponsor is and offence:

  • section 19B of the Act

Supplying biologicals that you have imported or that have been manufactured on your behalf when you are not the sponsor is an offence:

  • section 32BD of the Act

Supplying medical devices that you have imported, or that have been manufactured on your behalf, when you are not the sponsor is an offence:

  • section 41MI of the Act

It is the responsibility of the new sponsor to ensure that therapeutic goods they supply include their name and address where required to do so, for example:

  • medicines must have the name of the current sponsor (or supplier) on the label (this is a requirement of the standard in Therapeutic Goods Order 69 - General requirements for labels for medicines)
  • biologicals must have the name of the current sponsor on the container in which the biological is packed (this is a requirement of the standard in Therapeutic Goods Order 87 - General requirements for the labelling of biologicals)
  • it is an offence not to provide the name and address of the sponsor with a medical device (Regulation 10.2 of the Therapeutic Goods (Medical Devices) Regulations 2002).

Unless the Secretary has consented under section 14 of the Act, it is an offence for a person to supply a product that does not meet applicable standards (the Therapeutic Goods Orders are standards). Failure to comply is a ground for suspension or cancellation of the goods from the ARTG, as well as being an offence under the Act.

Changes to labels for medicines also have to be approved under section 9D of the Act.

No.

Changes to the approved Product Information for a medicine requires approval by the TGA under section 9D of the Act for which a fee is payable.

You are legally the new sponsor.

If you are now proposing to transfer the business to a third party, you should notify us of the change by which you became the sponsor as soon as possible and before transferring the business to a third party.

Then, if and when you transfer the business to the third party, it will be their responsibility as the new sponsor to notify us of that transfer.

Any application for the inclusion, registration or listing of new therapeutic goods in the ARTG at the time a sponsor transfer occurs is not affected by regulations 10AB, 10F or 10H. This is because those regulations only change the sponsorship in relation to entries that are already in the ARTG at the time of the relevant event.

If:

  • an application by a company for approval of therapeutic goods (that would result in a new entry in the ARTG) is under consideration by us at the time that another person becomes the new sponsor of that company' products, and
  • it is intended by the company that the responsibility for the application is to be the transferred to the new sponsor,

the new sponsor should contact the relevant TGA Branch about the next steps in relation to the application.

We strongly advise any person or company proposing to acquire a business or an interest involving therapeutic goods to check whether:

  • there are any such applications in progress with the TGA, and
  • the original applicant proposes to continue with the application in the event that the business or interest is transferred.

It is up to the relevant parties to come to appropriate arrangements about the transfer of any relevant intellectual property, information, and data that would (or may) be relevant to the application where:

  • there is an application in process that was submitted by the former sponsor, and
  • the product (which is the subject of the application) is part of the business that is intended to be transferred.

Applications for prescription medicines made under Streamlined Submission Process (SSP)

We will accommodate the transfer of these applications to a new applicant up until Milestone 5 of the SSP provided we receive appropriate information and authorisations from both the former and new applicant.

If the application is past this stage, contact us about other options.

Applications to vary a prescription medicine under section 9D of the Act

It is preferable that the sponsor transfer does not occur until we make a decision on the variation application.

If the transfer cannot be delayed, ensure you inform our Application Entry Team (AET) of the transfer, so we can avoid sending the decision letter to the former sponsor.

The AET is in our Medicines Authorisation Branch, and the email address is aet.application.entry.team@tga.gov.au.

No. They do not affect any responsibilities of the person as a manufacturer under therapeutic goods legislation.

Regulations 10AB, 10AC, 10F, 10FA, 10H and 10HA only apply to the transfer of the sponsorship from, or the change of name of, persons in relation to whom goods are included in the ARTG. This person is described as the 'sponsor'.

Where the 'sponsor' of therapeutic goods is also the manufacturer of the goods, and the sponsor sells the business (but remains the manufacturer), then those regulations apply only to the extent that they transfer the responsibilities of 'sponsor'.

If you are proposing to transfer a manufacturing business to another manufacturer, different procedures will apply, and you should contact the TGA. For instance, if you have a conformity assessment certificate, the provisions in Division 4.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 will be relevant.

If you are the new sponsor of registered therapeutic goods and you decide to change the name of the product (perhaps because it contains the name of the former sponsor), you will need to make an application to register the product under its new name on the ARTG under section 23 of the Therapeutic Goods Act 1989 (the Act). This is because once you rename the good, under subsection 16(1) of the Act, it will be taken to be separate and distinct goods from the product registered on the ARTG.

The same rule applies to listed goods.

No, sponsor transfer does not include transfer of the Manufacturer Evidence.

To ensure that appropriate manufacturer evidence is referenced in the ARTG entry the new sponsor must:

  1. Submit Manufacturer Evidence application as per the standard process.
  2. Once the evidence has been accepted submit a change request application to have the evidence linked to the ARTG entry or entries. Please refer to the Varying entries in the ARTG - medical devices and IVDs document for more information.

If the manufacturer evidence is appropriate for the kinds of devices included in the ARTG entry the change will be approved under section 9D of the Act. Further information on submitting manufacturer evidence can be found in Section 7 of the ARGMD - What a sponsor needs to know about conformity assessment.

Sponsors should note that it is a condition of the ARTG inclusion for all medical devices that they have available sufficient information to substantiate the application of the conformity assessment procedures or requirements, comparable to the conformity assessment procedures, to their kind of medical device, or has a procedure in place, including a written agreement with the manufacturer of the device to obtain such information.

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