zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Ms Nicole McLay - - PowerPoint PPT Presentation

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Annual Charge Exemption Scheme Information session

Ms Nicole McLay Assistant Secretary, Regulatory Business Services Branch Regulatory Support Division, TGA June 2015

Representatives from the TGA

• Ms Nicole McLay

– Assistant Secretary, Regulatory Business Services Branch

• Mr Vinod Mahajan

– Director, Regulatory Decision Review

• Ms Jo Flynn

– Regulatory Education Section

Annual Charge Exemption Scheme 1

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Annual Charge Exemption Scheme

• Background
• Key features
• New ACE scheme components
• Waivers
• New rates of annual charges
• Compliance program
• Sponsor actions
• Key dates

Annual Charge Exemption Scheme

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1990 2015

• Low value turnover exemption scheme introduced 1990

– No longer meets objectives – Complex and burdened with red tape – High number of complaints – Inconsistent with government’s cost recovery policy – Unsustainable and inequitable

• Consultation paper released in 2014
• New scheme commences 1 July 2015

Annual Charge Exemption Scheme

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Key features

• Rates of annual charges will reduce for some product categories

– from 5% to 23%

• Self declaration - online system to make notifications and declarations
• Significant reduction in administration - $3m p.a. in savings to industry
• A new waiver option for annual charges

Annual Charge Exemption Scheme

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New ACE scheme - components

Annual Charge Exemption (ACE) Scheme Begins 1 July 2015

New entries from 1 July 2015 will automatically qualify an d be granted exemption ACE applies until commencement

• f turnover

No application fee Existing entries at 1 July 2015 pre

• qualify

if LVT exempt in last 2 years

• n basis of

$0 turnover Annual self

• declaration

through client portal or by mail No TGA delegate decision

Annual Charge Exemption Scheme

Sponsors will not be invoiced for ACE entries

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Benefits of ACE

• No application fee – additional saving of $2.4m p.a. to industry
• A high number of current exemptions continue (74%)
• No third party accountant certification
• Only need to declare no turnover rather than the value of turnover
• Annual charges are reducing for:

– non-biological (chemical) prescription medicines, and – medical devices class IIa and above

• Annual charge invoices only issued for non-exempt entries
• Waivers available on public health/financial viability grounds

Annual Charge Exemption Scheme

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Waivers new waiver option under ACE

Waiver refused, annual charge payable Decision appealable

Annual Charge Exemption Scheme

Available for

registered medicines, biologicals, devices class IIa

• r higher and

IVD class 2 or higher

Decision by a TGA delegate

Waiver criteria

• public

health risk if product is removed from the ARTG

• product

becomes financially unviable if annual charge applies Annual application

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Chemical prescription medicines - 2 levels of annual charges

• Two levels of annual charges for chemical prescription medicines based on

pharmacovigilance activities/costs:

– Higher amount – relevant goods until 8th anniversary* – Lower amount – most generic medicines*, relevant goods past 8th anniversary

• Relevant goods = new chemical entity, extension of indications, or change to

intended patient group

• Other major variations such as new formulation, change of strength, dosage

forms – higher or lower amount depending on parent good

• *goods containing certain active ingredients will always attract the higher

amount – thalidomide, leflunomide, lenalidomide, mifepristone, clozapine and isotretinoin

Annual Charge Exemption Scheme

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Fees and charges 2015-16

• Non-biological prescription medicines

– 23% reduction in annual charge for lower amount – 5% reduction in annual charge for higher amount

• Medical devices

– 5% reduction in annual charges for class IIa and above

• All fees and charges

– 2.12% increase in fees and charges (CPI/WPI 2.5%)

• Revised fees and charges schedule - TGA website 1 July 2015

Annual Charge Exemption Scheme

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Audit and compliance program

• Audit and compliance assurance program will commence
• Uses existing information collecting provisions in the legislation
• Failure to provide information in response could result in

suspension/cancellation of entry

• Providing incorrect declaration results in cancellation of the

exemption – from year of turnover (multiple annual charges could become payable)

• Criminal Code applies
• Exempt and waived entries published on the website

Annual Charge Exemption Scheme

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Sponsor actions

• Letter sent to sponsors with pre-qualified entries 3 June

– please check your list of exempt entries – new entries will be automatically exempted

• Notify commencement of turnover for exempt entries at any time
• Declaration of $0 turnover between 1 - 22 July each year for prior year

to maintain exemption first declaration July 2016

• Payment of annual charges by 15 September each year

Annual Charge Exemption Scheme

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Key dates

June 2015 Advice to sponsors on existing entries, information sessions, website material 1 July 2015 ACE scheme commences Between 1 July and 22 July (annually starting 2016) Sponsor self-declares that entry had $0 turnover in the previous financial year Sponsor may notify commencement of turnover at any time July (annually) Annual charge invoices issued for non-exempt entries 15 September (annually) Due date for the payment of annual charges

Annual Charge Exemption Scheme

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA More information

TGA website - https://www.tga.gov.au/annual-charge-exemption-scheme email: ace.scheme@tga.gov.au

Annual Charge Exemption Scheme 13