Questions & answers about fees and charges
October 2006
What will the fees and charges pay for?
The Australia and New Zealand governments have determined that the ANZTPA will recover the full costs of its activities through industry fees and charges. This will include:
- Fees based on the Authority’s cost of performing assessment, evaluation and audit activities in respect of a particular sponsor or manufacturer.
- Annual charges for licences held by sponsors, to recover the cost of post-market activities, including maintaining the regulatory scheme.
The fees and charges will cover the cost of the Authority regulating therapeutic products including pre market product licensing, including safety assessments and evaluations, post market surveillance and audits, as well as education/information and other costs associated with maintaining the regulatory scheme.
Will there be a charge for the interim product licence?
Interim product licences will be issued free of charge and will be valid for the three year transition period. There will be an annual charge to maintain the interim licence.
Sponsors who wish to continue to supply products in Australia and New Zealand beyond the transition period, will need to apply for (and be granted) a full ANZTPA product licence before the end of the transition period.
How often will I have to pay fees and charges?
A fee will apply to applications for new product licences. Thereafter, an annual charge will apply to cover post market surveillance activities and contribute to the cost of maintaining the regulatory scheme.
What are the provisions for low turnover products?
It is proposed that ANZTPA will provide exemptions from the payment of annual licence charges for products that have a low turnover. An application fee would apply to assess the turnover of each product licence for which an exemption is sought and meet the cost of a validation program for exemptions. A maximum application fee would also be set, though this is proposed to be phased out over the transition period.
Sponsors of complementary medicines with a range of low turnover products would be able to apply for exemptions from annual product licence charges. The exemptions would be available for all Class 1 complementary medicines with a wholesale turnover of less than A$10,150 (i.e. where the A$690 annual product licence charge exceeds 6.8% of the wholesale turnover for that product).
(Please note these prices are indicative only and are subject to review following feedback from the consultation process).
Will there be reduced fees to help keep small companies in business?
Initiatives to be adopted by the Authority to assist smaller companies must be designed, as far as possible, to avoid cross-subsidisation from fees paid by other regulated companies and are likely to include:
- Exemptions for low wholesale/turnover;
- Reductions in annual licence charges for low therapeutic product turnover;
- Fee waivers for ‘orphan’ therapeutic products; and
- Instalment payment arrangements.
Would high fees squash innovation?
No, this is not the intention of the scheme.
What is the cost of a full ANZTPA product licence for a prescription medicine?
A schedule of indicative fees has been set for obtaining a full ANZTPA product licences.
Each of these vary depending on the current status of the product licence requirements. For example, an application for a product licence application for a new generic medicine would cost A$62,500.00. In comparison an application for a minor product licence variation –where no evaluation is required would cost A$1,150.00.
(Please note these prices are indicative only and are subject to review following feedback from the consultation process).
What happens about currency conversion and GST?
Fees and charges have been set using a single currency and will be converted to allow companies in either country to pay regulatory fees and charges in their domestic currency.
Regulatory fees and charges applied by the Authority will be subject to the goods and services tax regimes that apply in each country. New Zealand companies will be able to claim input tax credits, resulting in the same fees and charges applying in both countries.
Why are the indicative fees and charges in Australian dollars?
A currency needed to be selected for developing the proposals and it was agreed that Australian dollars would be used.
Will the exchange rate be set for a period of a year or six months to provide industry with some security?
A decision on this will be made after considering the submissions on the fees and charges proposals.
Will the joint Authority charge a fee for giving advice?
There are no proposals being considered to charge fees for advice about the operation of the regulatory scheme.
Will the cost of auditing reflect the risk of the product?
The Consultation Paper on Fees and Charges proposed that auditing fees be determined based upon factors such as: the number of manufacturing steps, the size of the manufacturing facility and the complexity of the manufacturing process (eg. manufacture of sterile products).
If a company does not wish to enter the joint market, do they have to pay the joint Authority fees – can’t they just pay local fees?
There will only be one regulatory Authority so there will be only be one set of fees and charges.
What happens at the end of the proposed three year transition period – full cost recovery? Are there any plans for subsidies for smaller businesses?
Full cost recovery, as detailed in the draft Fees and Charges paper, will come into effect at the commencement of the scheme.
While there are no subsidies for smaller businesses per se, the proposed fees and charges have addressed low turnover products and the Authority will set fees accordingly.
Will there be financial incentives to transfer into the joint scheme?
No. It will be mandatory to have a licence if you wish to sell or export product in the Australia and New Zealand market.
Will annual charges be linked with the beginning and end of the financial year?
Yes. The annual product licence charge is for the Financial Year, 1 July to 30 June.
Will annual charges continue increasing over time?
Fees and charges will be periodically reviewed to ensure they reflect any changes in costs or efficiencies.
URL: http://www.anztpa.org/about/qafees.htm