An area we see regular problems is device suppliers struggling to achieve transfer of sponsorship in the case of changes in distribution arrangements or other corporate restructures. TGA has a simple process where a sponsorship can be transferred to a new owner providing both parties sign off on the transfer. But if the current sponsor refuses to sign, this can lead to a world of pain and quite likely a need to start the whole regulatory process again to establish a new registration causing a delay on continued supply to market. There is no alternative if the existing sponsor cancels the entry.
Recent amendments to the Therapeutic Goods regulations included updates to Sponsor transfers and notifications of changes to ARTG entries in Australia. Although there has had an administrative process in place for some time, the regulations were lacking in specificity and this change makes explicit TGA’s expectations and the process for transfer registrations to another party or change of registrations in cases of such events as a corporate restructure or name change.
The new regulations now require changes of sponsor to be notified to the TGA within 3 months of the effective transfer. The TGA recognises the effective transfer as the date both parties having authorised the associated form. Most importantly, the new sponsor takes full responsibility for all regulatory requirements regardless of the TGA being notified. This has at times caused the new sponsor some confusion where they were unaware of this requirement.
TGA also requires a sponsor (who must be Australian company) to have formal contractual arrangements for compliance in place with the manufacturer (who more often than not is an overseas company). This agreement is to ensure all pre-market and post-market requirements can be met by the local sponsor while holding the ARTG entries and the manufacturer will provide the necessary pre and post market support through the life of the device. This should also allow the manufacturer an avenue to arrange potential transfers in the event the either party is not fulfilling their commercial or regulatory requirements.
All too often we see manufacturers falling into a commercial disagreement with their local distributor and, if that distributor also holds the TGA license, being held to ransom by the distributor refusing to relinquish the license. One way to avoid this is to use a third party to hold the license and separate the commercial distribution relationship from the regulatory compliance. Brandwood Biomedical offers sponsorship services, including a watertight contract that ensures control of the TGA license remains with the manufacturer – who can direct the future transfer of the license to any party.
Need help with management of TGA sponsorships or with TGA submissions and post-market support? Are you a Manufacturer looking local representation in Australia? We can provide comprehensive pre and post market regulatory support – giving you peace of mind in the Australian marketplace. Let’s talk about how we can support you. Email email@example.com or call our office on +61 2 9906 2984.