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Australia Regulator Seeks Feedback on Low-Value Turnover Exemption Scheme

April 11, 2014

Australia’s Therapeutic Goods Administration is proposing changes to the low value turnover exemption scheme, which lets companies request exemption from annual fees on entries in the Australian Register of Therapeutic Goods if the annual sales are less than or equal to 15 times the annual charge for register entry.

The TGA imposes the annual charges to fund regulatory operations such as postmarket safety monitoring and sponsor compliance with regulatory obligation. However, a review of the LVT scheme found it was not benefiting companies with low-volume turnover, the regulator said Thursday. Specifically, the review found that the top 20 sponsors pay 30 percent of annual LVT charges, while the rest pay 70 percent.

To ensure the fairness of the LVT scheme, the agency is proposing options:

  • Keep the scheme as it is;
  • Keep the scheme, with amendments aimed at improving efficiency;
  • Replace the scheme with a new scheme that grants exemptions only for products not supplied to Australia;
  • Replace the scheme with one that grants exemptions only to small businesses; or
  • Abolish the scheme entirely.

The TGA is soliciting comments on the options through May 23 and urges stakeholders to consider the following: Will an option aid small business? Will it support essential therapeutic goods that might not be otherwise available in-country? Will it support goods manufactured in Australia and exported?

Devicemakers are asked to provide a rationale for their choice of options, as well as how the proposed options will affect their business. The TGA also wants to know if eliminating or changing the scheme will limit the ability to enter or maintain goods on the ARTG, and whether implementation of any options proposed in the paper might cause supply disruptions.

Read the consultation at www.fdanews.com/ext/resources/files/04/04-11-14-TGATurnover.pdf. — Lena Freund

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