ARTG Annual Charge Due Dates, Cancellation and Reinstatement

1. Key takeaways

Unpaid annual charges do not automatically cancel an ARTG entry. The consequence chain is: the statutory due date is 1 October → after 20 working days unpaid, the Secretary may cancel → within 90 days after cancellation, payment of the annual charge plus the application fee allows a request for revocation of the cancellation, and once revoked the entry is treated as if it had never been cancelled. Separately, the statutory due date (1 October) and the payment deadline on the TGA invoice (15 September) are two different dates.

• Cancellation is discretionary (may), not an automatic consequence of non-payment.
• Overdue charges of 28 days or more can be recovered as a debt due to the Commonwealth.
• The 90 days revocation window under section 41GLB has retroactive effect.
• The ACE exemption lets eligible sponsors with zero turnover reduce holding costs.
• Suspension under section 41GA(1)(b) is available alongside cancellation.

The practical effect of the two-date design is that a well-run sponsor actually pays before the statutory clock matters. Companies that treat the invoice deadline as the real deadline stay clear of both the debt recovery mechanism and the cancellation discretion entirely.

2. Legal basis

The framework below covers the charging basis, the statutory due date, debt recovery, cancellation and suspension, the revocation remedy and the annual charge exemption mechanism. The dates below are the ones that decide whether an entry survives a payment failure.

1. Charging basis: Therapeutic Goods (Charges) Act 1989 (No. 22, 1990), section 4(1B); amounts prescribed in Therapeutic Goods (Charges) Regulations 2018 (F2018L00774), regulation 7(4).
2. Due date: section 44(1)(a)(b)(i) — the annual charge becomes payable on 1 October (for new entries, on the day calculated under the regulations); section 44(3) — the Secretary may specify a later date in writing.
3. Recovery: section 44B — charges unpaid after 28 days may be recovered as a debt due to the Commonwealth.
4. Cancellation and suspension: Therapeutic Goods Act 1989, section 41GL(f) — where the annual charge remains unpaid 20 working days after it becomes payable, the Secretary may cancel the entry; section 41GA(1)(b) — the Secretary may suspend.
5. Remedy: section 41GLB — within 90 days after cancellation, payment of the annual charge and the application fee supports a request for revocation of the cancellation; once revoked, the entry is treated as if it had never been cancelled.
6. Annual charge exemption mechanism (ACE): Therapeutic Goods Act 1989, section 44A and Therapeutic Goods Regulations 1990, sections 43AAA–43AAGF; the zero turnover declaration window runs 1–22 July; late declarations run 23 July–15 September (with payment, and no extension available); invoices are issued in early August, with full payment due by 15 September.

3. Expert insights

Insight 1: section 41GL(f) uses may, not deemed cancelled. Cancellation is a discretion of the Secretary, not an automatic consequence. This leaves room for payment and communication, but it also means no company can rely on an automatic grace period. Discretion also means unpredictability: two sponsors with identical arrears can receive different treatment depending on history and communication, which is another reason to resolve arrears before they mature.

Insight 2: the two dates must not be conflated. The statutory due date for the annual charge is 1 October (section 44(1)(b)(i)), and the cancellation clock runs from “20 working days after the charge became payable”; the payment deadline on the TGA invoice is 15 September. Using the invoice date to compute the cancellation clock gets the overdue start point wrong. Internal calendars should therefore show both dates with their own labels — one statutory, one administrative — and the reconciliation between them should be reviewed whenever a new entry is added.

Insight 3: the 90 days revocation window is a strong remedy — treated as never cancelled. The effect of revocation under section 41GLB is retroactive: the entry is treated as if it had never been cancelled. Supplies made before the revocation are therefore not retrospectively unlawful, which makes the remedy extremely valuable. It should not, however, be treated as a planning tool: revocation requires payment of both the annual charge and the application fee, and the 90 days window is short enough that a late decision wastes it.

The wider lesson is that annual charge management is calendar engineering. Every failure mode described in this article — debt recovery, suspension, cancellation — is a consequence of dates passing unnoticed rather than of fee amounts being unaffordable. A sponsor who instruments the calendar, assigns owners to each milestone and rehearses the revocation path once will rarely need the remedies at all.

It is also worth recording who at the sponsor is authorised to receive TGA correspondence on annual charges, and to act on it. Several of the deadlines above run from notices or invoices, and an unmonitored mailbox converts a manageable shortfall into a cancellation decision that then has to be undone under section 41GLB on a ticking clock.

4. Practical recommendations

• Set three milestones in the calendar: 1–22 July (ACE zero turnover declaration), 15 September (invoice full payment deadline) and 1 October (statutory due date).
• On receiving a cancellation notice, assess the section 41GLB 90 days revocation path immediately, and prefer paying the arrears over reapplying.
• For multi-entry companies, maintain an entry-to-annual-charge reconciliation table to prevent a single missed entry from triggering cancellation.
• Companies that qualify (zero turnover) should apply proactively for the ACE exemption to reduce holding costs.

5. Verification checklist

• □ The statutory due date of 1 October and the invoice deadline of 15 September are distinguished
• □ Cancellation is understood as a Secretary discretion (may), not automatic
• □ The cancellation clock of 20 working days after the due date is known
• □ The 90 days revocation window under section 41GLB is understood
• □ The ACE zero turnover declaration (1–22 July) has been assessed

Regulatory information verified as of 29 October 2026

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team coordinates Australian sponsor arrangements, ARTG annual charges, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com