Review Your Business' ARTG Entries For Exemption Charges
20th Jun 16
For the first time, businesses in the dental industry with products listed on the Australian Register of Therapeutic Goods (ARTG) will be required to make a declaration by 22 July 2016 regarding those entries which have not yet started to generate turnover in order to maintain their exemption from annual charges.
Key Issues For The Dental Industry —
Following the replacement of the Low Value Turnover (LVT) exemption scheme with the Annual Charge Exemption (ACE) scheme administered by the Therapeutic Goods Administration (TGA), businesses in the dental industry will, for the first time, be required to make a declaration to the TGA regarding those products registered on the Australian Register of Therapeutic Goods (ARTG) which have not yet generated turnover.
Declarations must be made between Friday 1 July 2016 and Friday 22 July 2016, and can be done so by logging in to the TGA Business Services (TBS) portal or by submitting a ‘Declaration of Low Value ($0) Turnover’ form which will be available on the TGA website by 1 July 2016. Further information as well as a link to the TBS portal is available via the links below:
Under the ACE scheme, products are exempt from the annual charge until they start to generate turnover. Once turnover commences on a product, annual charges become payable each year. Before annual charge invoices are issued, a business must make a declaration regarding its pre-qualified ACE products which have not yet started to generate turnover so that the TGA does not invoice for any unwarranted charges.
Businesses that wish to retain exemptions for 2016-17 must declare which products with the pre-qualified ACE status had not yet started generating turnover. The declaration will confirm ACE for those products for 2015-16 and pre-qualify them for ACE status for 2016-17.
In the event that product declarations that are not received by 22 July 2016, the ACE on the ARTG entry will cease and the annual charges for 2015-16 and 2016-17 will become payable by 15 September 2016.
The Australian Dental Industry Association (ADIA) has been in constant dialogue with the TGA regarding the scheme and its impact on businesses in the dental industry. This work included an external review of the ACE scheme which highlighted the increase in regulatory compliance costs and annual charges for the dental industry. These efforts are being coordinated by the ADIA-DRC Dental Regulation Committee and more information is available via the links below:
ADIA members wishing to offer feedback on these changes or to find out more about ADIA committees are encouraged to contact the ADIA national office via email on firstname.lastname@example.org or by telephone on 1300 943 094.
Currency of Information —
This update was issued on 20 June 2016 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations.
The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
11th Apr 18
As the TGA acts to introduce an application fee for placing Class 1 medical devices on the ARTG, ADIA has meet with senior ministerial advisors in order to seek an outcome to alleviate the impact on the dental industry.
27th Apr 18
At the request of the dental industry the Australian National Audit Office (ANAO) will review proposed new imposts that the Therapeutic Goods Administration (TGA) wishes to place on innovative dental product manufacturers and suppliers