If you become (or are considering becoming) a new sponsor as the result of any of the events described in regulations 10A, 10F and 10H (i.e. Change in sponsorship after death, bankruptcy or winding up or Change in business ownership), a number of legal obligations will then apply to you.
Depending on the type of therapeutic good, the legal obligations of sponsors are imposed by the:
- Therapeutic Goods Act 1989
- Therapeutic Goods Regulations 1990
- Therapeutic Goods (Medical Devices) Regulations 2002
The obligation to pay annual charges also applies, and is imposed by the:
Please note
These obligations arise:
- as soon as the relevant event occurs; and
- even if we have not been notified of that event; and
- even if we have not updated the relevant entries in the ARTG.
What should I, as a new sponsor, be aware of?
Information about the role and responsibilities of sponsors, as well as information on how to apply for an entry on the ARTG, can be found at: Role of the Sponsor.
Sponsors of all therapeutic goods in the ARTG are required to comply with a range of regulatory obligations, including the conditions of approval that are imposed on the goods while they remain in the ARTG.
All potential sponsors are advised to acquaint themselves with these requirements, which vary depending on the therapeutic good type.
For example:
- The sponsor of a medical device is required to:
- have access to sufficient information to substantiate that a medical device complies with the relevant Essential Principles; and
- be able to substantiate that the relevant conformity assessment procedures have been applied to the device.
- It may be a condition of registration for a prescription medicine that the sponsor:
- comply with requirements in a Risk Management Plan, and/or prepare and submit post-market studies to the TGA, or
- for a specified period, provide samples of a medicine and data to us for assessment prior to release of the medicine for sale.
- It is often a condition of ARTG inclusion for high-risk medical devices that annual reports be provided to us (for a specific period) about complaints and adverse reports relating to the device.
- A condition of inclusion for all types of medical devices is the requirement to retain all distribution records.
Requests for information
We can ask for information at any time to establish that certifications made by the sponsor (at the time of ARTG entry) for listed medicines, and all medical devices and biologicals remain correct and any conditions applicable to the entry are being complied with. We can take action to suspend or cancel the products from the ARTG if the certifications are no longer correct or conditions are not being complied with.
This includes:
- for medical devices - compliance with the essential principles and the application of conformity assessment procedures
- for all other types of therapeutic goods - compliance with standards
- compliance with advertising requirements (all therapeutic goods).
We recommend that any person (or company) proposing to take on responsibility for ARTG entries ensure it has access to any information that will allow it to respond to such requests, as it is reasonable to assume that the new sponsor will have access to data (and other information about a therapeutic good) submitted to us by the former sponsor.
Post market safety requirements for registered and listed medicines
Sponsors are obliged to notify us (within 15 calendar days) of any change in the details of the person nominated to be responsible for fulfilling the sponsor's pharmacovigilance obligations for ARTG entries. See: Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines (Version 1.3)
Manufacturing clearances
Any new sponsor will need to transfer (or renew) any manufacturing (GMP) clearance held by the former sponsor for any overseas manufacturer in relation to any listed or registered medicine, or biological, which is part of a transfer of sponsorship.
Both the former sponsor and the new sponsor will need to authorise the transfer of the GMP clearance to the new sponsor. If only some of the goods covered by the GMP clearance have been transferred, the new sponsor will need to submit a new application to us for GMP clearance.
Contact the Manufacturing Quality Branch of the TGA: gmpclearance@tga.gov.au.
Outstanding annual charges for the current financial year
Unless a low value exemption is in place, annual charges are payable for any entry that is in the ARTG for any part of a financial year.
Failure to pay annual charges payable in relation to an entry in the ARTG is a ground for suspension or cancellation of the entry from the ARTG.
We recommend that any person (or company) proposing to take on responsibility for therapeutic goods that are in the ARTG seek an assurance (or evidence) from the sponsor that any annual charges for the current financial year have been paid.
Low value exemptions for the current financial year
Sponsors are exempt from paying annual charges for goods in an ARTG entry if the goods qualify for an annual charge exemption.
Outstanding requests for variations to ARTG entries
We recommend any person or company proposing to take on responsibility for therapeutic goods in the ARTG to inquire about any outstanding applications we have for variations to the entry in relation to the goods (see FAQ section).
TGA regulatory action
We recommend any person or company proposing to take on responsibility for therapeutic goods in the ARTG to check with the current sponsor if any regulatory compliance action has been, or is being, proposed by us in relation to the goods.
Sponsors of therapeutic goods certify a range of matters about the good(s) as part of their entry in the ARTG. We can request information and/or documents from the sponsor at any time, and failure to respond, or to provide sufficient material for the TGA to be satisfied as to the matters and/or to the correctness of those certifications, may result in us proposing to suspend or cancel the product from the ARTG.
We may also:
- propose to suspend or cancel products in the ARTG because of matters that have arisen since a product was entered in the ARTG (usually after requesting information and/or documents from the sponsor)
- be proposing other post-market action relating to a product in the ARTG, for example, imposing additional conditions or change(s) to the Product Information document for a registered medicine because of a potential safety concern.
Record keeping
Sponsors are required to keep various records for all their goods in the ARTG. The most important of these is information about:
- adverse events, and
- supply in Australia of the goods.
We can ask the sponsor to provide information about these matters at any time, and the relevant sections in the Act under which this information can be sought are:
- registered and listed goods (including prescription, OTC and complementary medicines) - section 31
- biologicals - section 32JA
- medical devices - section 41JA.
We recommend that any person or company proposing to take on responsibility for therapeutic goods in the ARTG ensure that it has access to:
- information about adverse events and supply in Australia, and
- documents that have been provided to, or by, the TGA about those therapeutic goods.
Failure by a sponsor to provide requested information about products in the ARTG can result in suspension or cancellation of the products from the ARTG.