The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of medical devices intended to be marketed and used in Australia.
Table of content
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published its official guidelines dedicated to change notification procedures applicable to sponsorship changes.
The document explains the approach to be followed by the parties responsible for medical devices based on the existing legal framework and also provides additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance with the relevant provisions of the applicable legislation.
At the same time, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Notification of a Change in Sponsorship: Key Points
First of all, the authority acknowledges that changes in the sponsorship of therapeutic goods listed in the Australian Register of Therapeutic Goods (ARTG) can occur under several circumstances. These include the bankruptcy, or winding up of the sponsor’s business, or the transfer or assignment of the registration, listing, or inclusion of the goods to another individual or entity.
When such changes occur, the new sponsor needs to notify the authority of the event. This notification ensures that the new sponsor is recognized as responsible for the therapeutic goods in the ARTG entry, as the authority should at all times be able to contact the party responsible for a medical device allowed for marketing and use in the country.
Change of Sponsorship Due to Bankruptcy or Winding Up
In accordance with the applicable legislation, in the event of a sponsor’s bankruptcy, or business winding up, the responsibility for the therapeutic goods in the ARTG entry is transferred to the new sponsor. This new sponsor must inform the TGA of the change.
Detailed guidelines and forms for this process can be found in the official TGA Transfer of Sponsorship form. This form is available in both PDF and Microsoft Word formats. It provides the necessary steps and requirements for notifying the TGA about the change in sponsorship due to these events.
Change in Business or Product Ownership
When there is a transfer or assignment of the registration, listing, or inclusion of goods due to a change in business or product ownership, the new sponsor must notify the TGA about such changes. This is a critical step to ensure that the ARTG entries remain accurate and up-to-date.
The relevant forms for this process include “Notification: Transfer of Sponsorship”. The form outlines the process and necessary declarations for transferring sponsorship due to changes in business or product ownership.
Change of Sponsor Name
Sponsors are also required to notify the TGA if there is a change in their name or if they amalgamate with another company under a different name. While this does not constitute a change of sponsorship, it is necessary to update the ARTG entries to reflect the accurate sponsor name.
This notification must be done within three months of the name change. If the three-month period has passed, sponsors should notify the TGA as soon as possible.
The form for notifying the TGA of a name change is “Notification: Change of Sponsor Name”. It includes sections for making the relevant declarations about the change of name and the date on which it occurred.
Process for Notifying the TGA
When completing the notification forms, sponsors must ensure that the relevant declarations about the change of name are made, including the date on which the change occurred. The forms must be signed by the sponsor or a person authorized by the sponsor, such as a partner of a law or accountancy firm, or another individual with the sponsor’s authority.
Change of ABN or ACN
If the change in business name involves a change in the Australian Business Number (ABN) or Australian Company Number (ACN), this constitutes the formation of a new business entity. Consequently, it is considered a change of sponsorship and must follow the process for a change in business ownership.
Relevant Legislation
The Therapeutic Goods Regulations 1990 provide the legislative basis for changes in the sponsor’s name.
The specific regulations include:
- For Listed and Registered Therapeutic Goods: Regulation 10AC addresses changes of name for listed and registered therapeutic goods.
- For Medical Devices: Regulation 10FA deals with changes of name for medical devices.
- For Biologicals: Regulation 10HA pertains to changes of name for biologicals.
Conclusion
In summary, the present TGA guidance outlines the procedures and processes to be completed by the parties responsible for healthcare products placed on the country’s market in order to ensure the records are all the time up-to-date, and the authority has all the necessary information about sponsors. The document describes in detail different notification types depending on the nature of the changes, indicates specific forms to be used, and also provides additional clarifications to be taken into consideration by the parties involved.
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