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Consultation: Review of the low value turnover exemption scheme
This consultation closed on 23 May 2014
The Therapeutic Goods Administration (TGA) levies annual charges on entries in the Australian Register of Therapeutic Goods (the Register) to recover the costs of regulatory functions which cannot be reasonably assigned to individual businesses, or where such assignment would act as a deterrent to the effective regulation of therapeutic goods.
Annual charges fund post-market regulatory activities such as the monitoring of product safety and of sponsor compliance with regulatory obligation. The Therapeutic Goods (Charges) Regulations 1990 (the Charges Regulations) prescribe varied levels of charges for different classes of therapeutic goods, based on product risk.
The low value turnover exemption scheme (the LVT scheme), introduced in 1990, allows sponsors to seek an exemption from payment of annual charges for entries where the annual turnover is less than or equal to 15 times the annual charge for that Register entry.
The TGA has commenced a policy and operational review of the LVT scheme. The first stage is the release of the Review of the Low Value Turnover Exemption Scheme consultation paper.
Some of the questions to be considered in the review include:
- Is there a contemporary policy need for an LVT scheme (i.e. is there a problem to be solved by an LVT scheme);
- Are there other policy options available to address the policy need;
- Is there a problem with the operation of the current LVT scheme;
- What are the policy options and what is the net benefit of each of those options;
- How compatible is each option with other Government policy such as the Australian Government Cost Recovery Guidelines and competition policy.
Discussion and options are presented in the paper to generate feedback. It is acknowledged that changes to the LVT scheme would have varying impacts across individual sponsors.
Given the potential impact on a broad range of charges, sponsors and products, it is important that each sponsor consider the impact of the current LVT scheme on their product/s and the potential impact of changes to the LVT scheme.
- Consultation: Review of the low value turnover exemption scheme (pdf,360kb)
- Consultation: Review of the low value turnover exemption scheme (docx,419kb)
Document released for consultation on Thursday 10 April 2014.
Interested parties should respond by close of business on Friday 23 May 2014.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
Interested stakeholders are encouraged to provide a response, prompted by the questions posed in the paper. Stakeholders may respond to as many or as few of the questions as they wish and may provide additional information on the LVT scheme not covered by the questions.
The LVT scheme was introduced in 1990 and, as such, predates both the National Medicines Policy established in 1999 and the introduction of full cost recovery for the TGA in 1998.
Research traces the establishment of the LVT scheme to a policy objective of supporting manufacturers of small volume products, small start-up companies, herb growers and small companies making medical appliances whose turnover on a number of product lines might only be a few hundred or a few thousand dollars1.
The LVT scheme is now subject to policy review.
See: Submissions received
Submissions may address any, or all, of the options for the LVT scheme outlined in the paper or other identified issues. Submissions should include:
- Which option(s) you support and why. If you do not support any option, you may make suggestions for an alternative which is acceptable to you and provide a rationale.
- An assessment of how the proposed options will affect you or your business (either positively or negatively). Please attempt to quantify this (e.g. financial impacts).
In addition, submissions might include:
- Feedback on whether the removal, or changes to, the LVT scheme would limit your ability to enter or maintain goods on the Register;
- Feedback on whether the implementation of any of the options presented could lead to cessation of supply of essential therapeutic goods, causing potential public health risks; and
- Feedback on any other options which may achieve the objectives but that may not have been considered.
What will happen
All submissions will be placed on the TGA internet site unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA internet site.
At the close of the consultation period, the TGA will collate and analyse submissions on matters that are within the scope of the consultation. An update on the progress of the review will be provided on the TGA website after the close of the consultation period. The TGA will then prepare advice for the consideration of Government.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- The TGA will disclose your name and (if applicable) your designation/work title on the TGA internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA internet site (please complete the coversheet).
- Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
Any questions relating to submissions should be directed to the Regulatory Integrity Section by email to email@example.com or by telephone to 02 6221 6933.