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Important annual charge deadlines

26 June 2020

Sponsors are reminded that if your product is no longer supplied, you can cancel your entry from the ARTG. Products on the ARTG on 1 July 2020 will incur a 2020-21 annual charge (unless exempt).

Information on how to request to cancel an entry/entries from the Australian Register of Therapeutic Goods (ARTG) is available on this website.

2020 important dates for annual charges

ALL sponsors with an existing ARTG entry
Date Details
30 June 2020 Deadline to cancel any entries from the ARTG to prevent incurring 2020-21 annual charges (unless otherwise exempt)
1 July to 22 July 2020

Period for sponsors to submit their declarations of $0 turnover for any ARTG entries which:

  1. were exempt from annual charges under the Annual Charge Exemption (ACE) scheme in 2019-20, and
  2. had $0 turnover 2019-20, so therefore eligible for ACE again in 2020-21
23 July to 15 September 2020 Sponsor who missed the declaration period of 1 July to 22 July 2020 have the opportunity to apply to have ACE reinstated between 23 July and 15 September 2020
>1 August 2020 2020-21 annual charge invoices for all non-exempt ARTG entries will be issued
15 September 2020 Due date for payment of annual charge invoices [issued in August 2020].

Please direct enquiries relating to the above information via email to:


Flyer

Update your organisation details

It is the responsibility of the Administrator to update the organisation details to ensure correspondence from the TGA is sent to the correct recipient. The Administrator can follow the instructions available on the TGA Website Questions and answers for administrators.

Important dates
Dates Details Enquiries
June 2020 Fees and Charges accountsrec@health.gov.au
30 June 20209 ARTG Cancellation ebs@health.gov.au
1-22 July 2020 ACE $0 Declaration ace.scheme@health.gov.au
Early August 2020 Annual Charges accountsrec@health.gov.au
15 September 2020 Annual Charge Due Date accountsrec@health.gov.au
23 July - 15 September 2020 ACE Reinstatement ace.scheme@health.gov.au

2020-21 Fees and charges

The Government recently approved a 1.95% increase to most TGA fees and charges for 2020-21. The revised Schedule of Fees and Charges were published on the TGA website in June 2020. The new fees and charges schedule will take effect from 1 July 2020.

ARTG cancellation

To avoid incurring an annual charge for the next financial year, we must receive cancellation requests by 5:00pm, 30 June 2020 if you wish to cancel any ARTG entries for your organisation. If we don't receive your request by the deadline, the entry/entries will be active on the ARTG on 1 July 2020 and will therefore incur annual charge(s) for financial year 2020-21.

Annual Charge Exemption (ACE)

Between 1 July and 22 July annually, Sponsors are required to make a declaration of $0 turnover to confirm (retrospectively) that an ACE entry has not commenced generating turnover during the previous financial year. If the TGA does not receive a $0 turnover declaration it is assumed that the entry has commenced generating turnover in the previous financial year and result in the ACE ceasing on the entry. If the sponsor fails to make a declaration between 1 July and 22 July of a year and the ACE entry did not commence generating turnover in the previous financial year, the sponsor can apply to have the exemption reinstated between 23 July and 15 September each year.

Annual charges

Annual charges apply to all product entries (except export only products and ACE) on the ARTG at any time during a financial year, regardless of whether the product is subsequently cancelled within the same financial year.