Notes to and Forming Part of the Financial Statements

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Note 1: Summary of Significant Accounting Policies
Note 2: Events After the Reporting Period
Note 3: Expenses
Note 4: Income
Note 5: Financial Assets
Note 6: Non-Financial Assets
Note 7: Payables
Note 8: Provisions
Note 9: Cash Flow Reconciliation
Note 10: Contingent Assets and Liabilities
Note 11: Senior Executive Remuneration
Note 12: Remuneration of Auditors
Note 13: Financial Instruments
Note 14: Financial Assets Reconciliation
Note 15: Special Account
Note 16: Reporting of Outcomes
Note 17: Cost Recovery

Note 1:   Summary of Significant Accounting Policies

1.1 Objective of Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) is a division of the Department of Health and Ageing which is an Australian Government controlled entity. The TGA contributes to Outcome 1 of the Department of Health and Ageing – a reduction in the incidence of preventable mortality and morbidity in Australia, including through regulation and national initiatives that support healthy lifestyles and disease prevention.

Therapeutic goods are regulated to ensure that medicinal products and medical devices in Australia meet standards of safety, quality and efficacy at least equal to that of comparable countries. These products and devices should be made available in a timely manner and the regulatory impact on business kept to a minimum. This is achieved through a risk management approach to pre-market evaluation and approval of therapeutic products intended for supply in Australia, licensing of manufacturers and post market surveillance.

The continued existence of the TGA in its present form and with its present programs is dependent on Government policy. TGA is reflected as a special account in the Department of Health and Ageing’s statements.

On 20 June 2011, the Australian and New Zealand Prime Ministers signed a statement of intent on a plan to progressively implement a joint agency over a period of up to five years that will combine the Australian TGA and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

1.2 Basis of Preparation of the Financial Statements

A determination was made under the Financial Management and Accountability Act 1997 for the TGA Special Account to be treated as a business operation.  The financial statements and notes are therefore required by section 49 of the Financial Management and Accountability Act 1997 and are general purpose financial statements.

The financial statements and notes have been prepared in accordance with:

• Finance Minister’s Orders (or FMOs) for reporting periods ending on or after 1 July 2011; and
• Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board (AASB) that apply for the reporting period.

The financial statements are presented in Australian dollars and values are rounded to the nearest thousand dollars unless otherwise specified.

The financial statements and notes have been prepared on an accrual basis and are in accordance with the historical cost convention, except for certain assets at fair value. Except where stated, no allowance is made for the effect of changing prices on the results or the financial position.

Unless an alternative treatment is specifically required by an Accounting Standard or the FMOs, assets and liabilities are recognised in the balance sheet when and only when it is probable that future economic benefits will flow to the entity or a future sacrifice of economic benefits will be required and the amounts of the assets or liabilities can be reliably measured.  However, assets and liabilities arising under executory contracts are not recognised unless required by an accounting standard.  Liabilities and assets that are unrealised are reported in the schedule of commitments.

Unless alternative treatment is specifically required by an accounting standard, income and expenses are recognised in the statement of comprehensive income when, and only when, the flow, consumption or loss of economic benefits has occurred and can be reliably measured.

1.3 Significant Accounting Judgements and Estimates

No accounting assumptions or estimates have been identified that have a significant risk of causing a material adjustment to carrying amounts of assets and liabilities within the next accounting period.

1.4 New Australian Accounting Standards

Adoption of New Australian Accounting Standard Requirements

No accounting standard has been adopted earlier than the application date as stated in the standard.

Revised standards that were issued prior to the sign-off date and are applicable to the current reporting period did not have a financial impact, and are not expected to have a future financial impact on the TGA.

Future Australian Accounting Standard Requirements

No new standards, revised standards, interpretations and amending standards that were issued by the Australian Standards Board prior to the sign-off date, are expected to have a financial impact on the TGA for future reporting periods.

1.5 Revenue

Revenue from Government

Revenue was provided to the TGA (through the Department of Health and Ageing) to provide interest supplementation for surplus amounts standing to the credit of the Official Public Account following changes to whole-of-government agency banking arrangements in 2003, and for funding activity associated with progressive implementation of the joint agency.

Revenues from Sale of Goods and Rendering of Services

Revenue from the sale of goods is recognised when:

• the risks and rewards of ownership have been transferred to the buyer;
• the agency retains no managerial involvement or effective control over the goods;
• the revenue and transaction costs incurred can be reliably measured; and
• it is probable that the economic benefits associated with the transaction will flow to the TGA.

Revenue from rendering of services is recognised by reference to the stage of completion of contracts at the reporting date. The revenue is recognised when:

• the amount of revenue, stage of completion and transaction costs incurred can be reliably measured; and
• the probable economic benefits associated with the transaction will flow to the entity.

The stage of completion of contracts at the reporting date is determined by reference to the proportion that costs incurred to date bear to the estimated total costs of the transaction.

The TGA recovers the cost of all activities undertaken within the scope of the Therapeutic Goods Act 1989 from industry through fees and charges and is recognised as revenue only when it has been earned.

Annual charges for entries on the Australian Register of Therapeutic Goods and manufacturing licence charges are recognised as revenue in the financial year to which the charges relate and are non-refundable, except where exemption is given on the basis of low value turnover.

Minor application fees, evaluation fees and conformity assessment fees (less than $10,000) are recognised as revenue on receipt.

Major application, evaluation and conformity assessment fees are recognised progressively as services are performed.

Receivables for goods and services are recognised at the nominal amounts due less any impairment allowance account. Collectability of debts is reviewed at end of reporting period. Allowances are made when collectability of the debt is no longer probable.

1.6 Gains

Resources Received Free of Charge

Resources received free of charge are recognised as revenue when, and only when, a fair value can be reliably determined and the services would have been purchased if they had not been donated.  Use of those resources is recognised as an expense. Resources received free of charge are recorded as either revenue or gains depending on their nature.  

Contributions of assets at no cost of acquisition or for nominal consideration are recognised as gains at their fair value when the asset qualifies for recognition, unless received from another Government agency or authority as a consequence of a restructuring of administrative arrangements.

Sale of Assets

Gains from disposal of non-current assets are recognised when control of the asset has passed to the buyer. The gain or loss on disposal of non-current assets is determined as the difference between the carrying amount of the asset at the time of disposal and the net proceeds of disposal.

1.7 Employee Benefits

Liabilities for services rendered by employees are recognised at the reporting date to the extent that they have not been settled.

Liabilities for ‘short-term employee benefits’ (as defined in AASB 119 Employee Benefits ) and termination benefits due within twelve months of the end of the reporting period are measured at their nominal amounts.

The nominal amount is calculated with regard to the rates expected to be paid on settlement of the liability.  

All other long-term employee benefits are measured as the net total of the present value of the defined benefit obligation at the end of the reporting period minus the fair value at the end of the reporting period of plan assets (if any) out of which the obligations are to be settled directly.

(a) Leave

The liability for employee benefits includes provisions for annual leave and long service leave. No provision has been made for sick leave as all sick leave is non-vesting and the average sick leave taken in future years by employees of the TGA is estimated to be less than the annual entitlement for sick leave.

The leave liabilities are calculated on the basis of employees’ remuneration at the estimated salary rates that will apply at the time the leave is taken, including the TGA’s employee superannuation contribution rates to the extent that leave is likely to be taken during service rather than paid out on termination.

The liability for long service leave is determined with reference to an actuarial assessment last conducted on 26 May 2011. An actuary is engaged every 3 years to reassess the leave liability. The estimate of the present value of the liability takes into account attrition rates and pay increases through promotion and inflation.

(b) Separation and Redundancy

Provision is made for separation and redundancy benefit payments. The TGA recognises a provision for termination when it has developed a detailed formal plan for the terminations and has informed those employees affected that the terminations will be carried out. No such provision has been made for this financial year.

(c) Superannuation

Under the Superannuation Legislation Amendment (Choice of Funds) Act 2004, staff of the TGA are able to become members of any complying superannuation fund. A complying superannuation fund is one that meets the requirements under the Income Tax Assessment Act 1997 and the Superannuation Industry (Supervision) Act 1993.

The majority of staff of the TGA are members of the Commonwealth Superannuation Scheme (CSS), the Public Sector Superannuation Scheme (PSS), or the PSS accumulation plan (PSSap).

The CSS and PSS are defined benefit schemes for the Australian Government. The PSSap and other compliant superannuation funds are defined contribution schemes.

The liability for defined benefits is recognised in the financial statements of the Government and is settled by the Government in due course. This liability is reported by the Department of Finance and Deregulation as an administered item.

The TGA makes employer contributions to the employee superannuation schemes at rates determined by an actuary to be sufficient to meet the current cost to the Government of the superannuation entitlements of the TGA’s employees. The TGA accounts for the contributions as if they were contributed to a defined contribution plan.

The liability for superannuation recognised at 30 June 2012 represents outstanding contributions for the period between the last pay day and the end of the financial year.

1.8 Leases

A distinction is made between finance leases and operating leases.  Finance leases effectively transfer from the lessor to the lessee substantially all the risks and benefits incidental to ownership of leased non-current assets. The TGA has no finance leases.

In operating leases, the lessor effectively retains substantially all such risks and benefits. Operating lease payments are expensed on a straight line basis over the term of the lease which is representative of the pattern of benefits derived from the leased assets.

1.9 Cash and Cash Equivalents

Cash and cash equivalents include cash on hand and cash in TGA’s special account.   The remaining balance of the TGA’s special account is held in the Official Public Account and it is reflected in the Trade and Other Receivable balance.

1.10 Financial assets

The TGA classifies its financial assets in the following categories:         

• financial assets at fair value through profit or loss;            
• held-to-maturity investments;
• available-for-sale financial assets; and
• loans and receivables.                             

The classification depends on the nature and purpose of the financial assets and is determined at the time of initial recognition.         

Financial assets are recognised and derecognised upon ‘trade date’.                   

Effective interest method

The effective interest method is a method of calculating the amortised cost of a financial asset and of allocating interest income over the relevant period.  The effective interest rate is the rate that exactly discounts estimated future cash receipts over the expected life of the financial asset, or, where appropriate, a shorter period.

Income is recognised on an effective interest rate basis except for financial assets that are recognised ‘at fair value through profit or loss’.

Financial assets at fair value through profit or loss

Financial assets are classified as financial assets at fair value through profit or loss where the financial assets:

• have been acquired principally for the purpose of selling in the near future;               
• are a part of an identified portfolio of financial instruments that the TGA manages together and has a recent actual pattern of short-term profit-taking; or
• are derivatives that are not designated and effective as a hedging instrument.

Assets in this category are classified as current assets.

Financial assets at fair value through profit or loss are stated at fair value, with any resultant gain or loss recognised in profit or loss.  The net gain or loss recognised in profit or loss incorporates any interest earned on the financial asset. 

Loans and receivables

Trade receivables, loans and other receivables that have fixed or determinable payments that are not quoted in an active market are classified as ‘loans and receivables’. These are classified as non-current assets.  Loans and receivables are measured at amortised cost using the effective interest method less impairment.  Interest is recognised by applying the effective interest rate.

Impairment of financial assets

Financial assets are assessed for impairment at each balance date.    

Financial assets held at amortised cost - If there is objective evidence that an impairment loss has been incurred for loans and receivables, the amount of the loss is measured as the difference between the asset’s carrying amount and the present value of estimated future cash flows discounted at the asset’s original effective interest rate.  The carrying amount is reduced by way of an allowance account.  The loss is recognised in the statement of comprehensive income.  

Financial assets - If there is objective evidence that an impairment loss has been incurred, the amount of the impairment loss is the difference between the carrying amount of the asset and the present value of the estimated future cash flows discounted at the current market rate for similar assets.

1.11 Financial Liabilities

Financial liabilities are classified as either financial liabilities ‘at fair value through profit or loss’ or other financial liabilities. Financial liabilities are recognised and derecognised upon ‘trade date’.

Other financial liabilities

Other financial liabilities including borrowings are initially measured at fair value, net of transaction costs. These financial liabilities are subsequently measured at amortised cost using the effective interest method, with interest expense recognised on an effective yield basis.    

The effective interest method is a method of calculating the amortised cost of a financial liability and of allocating interest expense over the relevant period.  The effective interest rate is the rate that exactly discounts estimated future cash payments through the expected life of the financial liability, or, where appropriate, a shorter period. Supplier and other payables are recognised at amortised cost.  Liabilities are recognised to the extent that the goods or services have been received (and irrespective of having been invoiced).

1.12 Contingent Liabilities and Contingent Assets

Contingent liabilities and contingent assets are not recognised in the balance sheet but are disclosed in the relevant schedules and notes. They may arise from uncertainty as to the existence of a liability or asset, or represent an existing liability or asset in respect of which settlement is not probable or the amount cannot be reliably measured. Contingent assets are disclosed when settlement is probable but not virtually certain, and contingent liabilities are disclosed when settlement is greater than remote.

1.13 Acquisition of Assets

Assets are recorded at cost on acquisition except as stated below.  The cost of acquisition includes the fair value of assets transferred in exchange and liabilities undertaken. Financial assets are initially measured at their fair value plus transaction costs where appropriate.

Assets acquired at no cost, or for nominal consideration are initially recognised as assets and revenues at their fair value at the date of acquisition, unless acquired as a consequence of restructuring of administrative arrangements. In the latter case, assets are initially recognised at the amounts at which they were recognised in the transferor agency’s accounts immediately prior to the restructuring.

1.14 Property, Plant and Equipment

Asset Recognition Threshold

Purchases of property, plant and equipment including land, buildings and infrastructure are recognised initially at cost in the balance sheet, except for purchases costing less than $2,000. Leasehold improvements to properties with values of $10,000 or greater are capitalised. Any purchases under the thresholds are expensed in the year of acquisition. Where bulk purchases of a group of similar assets within the same asset class are acquired they are treated as one asset for the purpose of applying the capitalisation threshold.

The initial cost of an asset includes an estimate of the cost of dismantling and removing the item and restoring the site on which it is located. This is particularly relevant to ‘make good’ provisions in leasing agreements for premises taken up by the TGA where there exists an obligation to restore the premises to their original condition at the conclusion of the lease. These costs are included in the value of the TGA’s leasehold improvements with a corresponding provision for the ‘make good’ recognised.

Revaluations

Fair values for each class of asset are determined as shown below:

Following initial recognition at cost, property, plant and equipment are carried at fair value less subsequent accumulated depreciation and accumulated impairment losses. Valuations are conducted with sufficient frequency to ensure that the carrying amounts of assets do not materially differ from the assets’ fair values as at the reporting date. Independent valuations are conducted every three years, with desktop reviews carried out in the other years.

An independent asset revaluation was conducted in 2011-12 by the Australian Valuation Office.

Revaluation adjustments are made on a class basis. Any revaluation increment is credited to equity under the heading of asset revaluation reserve except to the extent that it reverses a previous revaluation decrement of the same class that was previously recognised through operating results. Revaluation decrements for a class of assets are recognised through profit and loss except to the extent that they reverse a previous revaluation increment for that class.

Any accumulated depreciation at the revaluation date is eliminated against the gross carrying amount of the asset and the asset is restated to the revalued amount.

Depreciation

Depreciable property, plant and equipment assets are written-off to their estimated residual values over their estimated useful lives to the TGA using in all cases, the straight line method of depreciation.

Depreciation rates (useful lives) are reviewed at each reporting date and necessary adjustments are made in the current, or current and future reporting periods, as appropriate. Residual values are re-estimated only when assets are revalued.

The following are minimum and maximum useful lives for the different asset classes. These are not necessarily indicative of typical useful lives for these asset classes.

Impairment

All assets were assessed for impairment at 30 June 2012. Where indications of impairment existed, the asset’s recoverable amount was estimated and an impairment adjustment made if the asset’s recoverable amount was less than its carrying amount.

The recoverable amount of an asset is the higher of its fair value less costs to sell and its value in use. Value in use is the present value of the future cash flows expected to be derived from the asset. Where the future economic benefit of an asset is not primarily dependent on the asset’s ability to generate future cash flows, and the asset would be replaced if the TGA were deprived of the asset, its value in use is taken to be its depreciated replacement cost.

1.15 Intangibles

The TGA’s intangibles comprise internally developed and purchased software for internal use. These assets are carried at cost less accumulated amortisation and impairment. Internally developed software and purchased software with values of $100,000 or greater are capitalised.

Software is amortised on a straight-line basis over its anticipated useful life. The useful lives of the TGA’s software are 3 to 10 years (2010-11: 3 to 10 years).

1.16 Taxation

The TGA is exempt from all forms of taxation except Fringe Benefits Tax (FBT), the Goods and Services Tax (GST) and certain excise and customs duties.

Revenues, expenses, assets and liabilities are recognised net of GST, except:

• where the amount of GST incurred is not recoverable from the Australian Taxation Office; and
• for receivables and payables which are recognised inclusive of GST.

1.17 Comparative Figures

Comparative figures have been adjusted to conform to changes in presentation in these financial statements, where required.

Note 2: Events After the Reporting Period

No reportable events occured after the balance date.

Note 3: Expenses

Note 4: Income

Note 5: Financial Assets

Reconciliation of the Impairment Allowance Account:

Movements in relation to 2012

Note 6: Non-Financial Assets

No indicators of impairment were found for land and building assets.

No land and building assets are expected to be sold or disposed of within the next 12 months.

Revaluations

All revaluations are conducted in accordance with the revaluation policy stated at Note 1. In 2011-12 the Australian Valuation Office (AVO) conducted a revaluation of land and building assets.

Revaluation increments include $0.549 million (2010-11:Nil).

All increments were transferred to the asset revaluation reserve by asset class and included in the equity section of the balance sheet. No decrements were expensed (2010-11:Nil).

No indicators of impairment were found for property, plant and equipment.

No property, plant or equipment is expected to be sold or disposed of within the next 12 months.

Revaluations

All revaluations are conducted in accordance with the revaluation policy stated at Note 1.  In 2011-12 the Australian Valuation Office (AVO) conducted a revaluation of property, plant and equipment.

Revaluation increments include $0.065 million (2010-11:Nil).

All increments were transferred to the asset revaluation reserve by asset class and included in the equity section of the balance sheet. No decrements were expensed (2010-11:Nil).

No indicators of impairment were found for intangible assets. 

No intangible assets are expected to be sold or disposed of within the next 12 months.

No indicators of impairment were found for other non-financial assets.

Note 7: Payables

Note 8: Provisions

Reconciliation of other provisions:

Note 9: Cash Flow Reconciliation

Note 10: Contingent Liabilities and Assets

Contingent Assets

Quantifiable Contingencies

At 30 June 2012 the TGA did not have any quantifiable contingent assets (2010-11:Nil).

Unquantifiable Contingencies

At 30 June 2012 the TGA did not have any unquantifiable contingent assets (2010-11:Nil).

Contingent Liabilities

Quantifiable Contingencies

At 30 June 2012 the TGA had one quantifiable contingent liability arising from a federal court proceeding estimated to be $0.1 million (2010-11:Nil).

Unquantifiable Contingencies

As at 30 June 2012

The TGA has a contingent liability to indemnify the lessor of the TGA’s building against all claims arising from negligent use or misuse of the services; and indemnify against claims arising from the construction, maintenance, operation, repair and keeping safe of the laboratories upgraded or constructed by the TGA.

The TGA has provided an indemnity to its transactional banker in relation to any claims made against the bank resulting from errors in the TGA’s payment files.

As at 30 June 2011

The TGA had a contingent liability to indemnify the lessor of the TGA’s building against all claims arising from negligent use or misuse of the services; and indemnify against claims arising from the construction, maintenance, operation, repair and keeping safe of the laboratories upgraded or constructed by the TGA.

The TGA has provided an indemnity to its transactional banker in relation to any claims made against the bank resulting from errors in the TGA’s payment files.

Significant Remote Contingencies

At 30 June 2012 the TGA did not have any significant remote contingencies (2010-11:Nil).

Note 11: Senior Executive Remuneration

Notes:

1. Note 11A is prepared on an accrual basis (therefore the performance bonus expenses disclosed above may differ from the cash bonus disclosed in Note 11B).
2. Note 11A excludes acting arrangements and part year service where total remuneration expensed for a senior executive was less than $150,000.

Notes:

1. This table reports substantive senior executives who received remuneration during the reporting period.  Each row is an averaged figure based on headcount for individuals in the band.
2. 'Reportable salary' includes the following:
   1. gross payments (less any bonuses paid, which are disclosed in the 'bonus paid' column); and
   2. reportable fringe benefits (at the net amount prior to 'grossing up' to account for tax benefits).
3. The 'contributed superannuation' amount is the average actual superannuation contributions paid to senior executives in that reportable remuneration band during the reporting period, including any salary sacrificed amounts, as per the individuals' payslips.
4. 'Reportable allowances' are the average actual allowances paid as per the 'total allowances' line on individuals' payment summaries.
5. 'Bonus paid' represents average actual bonuses paid during the reporting period in that reportable remuneration band.  The 'bonus paid' within a particular band may vary between financial years due to various factors such as individuals commencing with or leaving the TGA during the financial year.
6. Various salary sacrifice arrangements were available to senior executives including superannuation, motor vehicle and expense payment fringe benefits.  Salary sacrifice benefits are reported in the 'reportable salary' column, excluding salary sacrificed superannuation, which is reported in the 'contributed superannuation' column.

Notes:

1. This table reports staff:
   1. who were employed by the TGA during the reporting period;
   2. whose reportable remuneration was $150,000 or more for the financial period; and
   3. were not required to be disclosed in Tables A, B or director disclosures.
   Each row is an averaged figure based on headcount for individuals in the band.
   TGA staff include medical officers, legal officers and scientists. Details of salary and entitlements are included in the Department of Health and Ageing Enterprise Agreement 2011-2014.
2. 'Reportable salary' includes the following:
   1. gross payments (less any bonuses paid, which are disclosed in the 'bonus paid' column); and
   2. reportable fringe benefits (at the net amount prior to 'grossing up' to account for tax benefits).
3. The 'contributed superannuation' amount is the average actual superannuation contributions paid to staff in that reportable remuneration band during the reporting period, including any salary sacrificed amounts, as per the individuals' payslips.
4. 'Reportable allowances' are the average actual allowances paid as per the 'total allowances' line on individuals' payment summaries.
5. 'Bonus paid' represents average actual bonuses paid during the reporting period in that reportable remuneration band.  The 'bonus paid' within a particular band may vary between financial years due to various factors such as individuals commencing with or leaving the TGA during the financial year.
6. Various salary sacrifice arrangements were available to other highly paid staff including superannuation, motor vehicle and expense payment fringe benefits.  Salary sacrifice benefits are reported in the 'reportable salary' column, excluding salary sacrificed superannuation, which is reported in the 'contributed superannuation' column.

Note 12: Remuneration of Auditors

No other services were provided by the ANAO.

Note 13: Financial Instruments

The movement in the impairment account reflects an increase in the impairment provision and the write down of receivables.

Note 13C Credit risk 

TGA's maximum credit risk in each class of financial assets is the carrying amount of the assets. The total amount of trade receivables is $5.494 million (2011: $4.517 million).  TGA has assessed the risk of default on payment and allowed impairment of $0.972 million in 2012 (2011: $0.614 million).

The following table illustrates the TGA's gross exposure to credit risk, excluding any collateral or credit enhancements.

TGA holds no collateral to mitigate against risk.

Credit quality of financial instruments not past due or individually determined as impaired

Ageing of financial assets that were past due but not impaired for 2012

Ageing of financial assets that were past due but not impaired for 2011

Note 13D Liquidity risk

The TGA's financial liabilities are payables. The exposure to liquidity risk is based on the notion that the TGA will encounter difficulty in meeting its obligations associated with financial liabilities. This is highly unlikely as cost recovery policies ensure there are appropriate resources to meet its financial obligations.

The TGA has no derivative financial liabilities in either 2012 or 2011.

Note 13E Market risk

TGA has no material exposure to currency risk, interest rate risk or other price risk.

Note 14: Financial Assets Reconciliation

Note 15: Special Account

Section 83 of the Constitution provides that no amount may be paid out of the Consolidated Revenue Fund except under an appropriation made by law. The Department of Finance and Deregulation provided information to all agencies in 2011 regarding the need for risk assessments in relation to compliance with statutory conditions on payments from special appropriations, including special accounts. 

The TGA operates one special account established under section 21 of the Financial Management and Accountability Act 1997. The purposes of the account are set out in section 45 of the Therapeutic Goods Administration Act 1989 (the Act) and are; to make payments to further the objects of the Act; and to enable the Commonwealth to participate in the international harmonisation of regulatory controls on therapeutic goods and other related activities.

In 2011-12 an internal audit was conducted on the TGA’s administration of the special account which included testing of a range of expenditure against the purposes of the special account. This work, and the broad nature of the purpose of the account, has provided the TGA with confidence that the risk of non-compliance of special account payments is at an acceptably low level. The TGA will continue to ensure its compliance with statutory conditions for payment. 

Note 16:  Reporting of Outcomes

The TGA is a division of the Department of Health and Ageing.  The TGA contributes to Outcome 1 of the Department of Health and Ageing - a reduction in the incidence of preventable mortality and morbidity in Australia, including through regulation and national initiatives that support healthy lifestyles and disease prevention.  All costs are attributable to the Outcome.

Note 17: Cost Recovery

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