Notifications to prescription medicines Low risk changes that do not affect safety, quality or efficacy

Jenny Burnett Scientific Evaluation Branch Therapeutic Goods Administration ARCS Webinar 10 November 2017

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Notifications to prescription medicines

MMDR reforms

Notifications process

Updates to the minor

variations e-form

ARCS webinar: Notifications to prescription medicines

MMDR Reforms Risk-based approach to minor variations - notifications

All registered medicines: • OTC • Registered complementary medicines • Prescription (chemical and biological medicines)

Special mention: biologicals

Staged implementation

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Notifications process Human touch points

E-Form Invoice Paid ($$) Acknowledgement ARTG File

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The automated workflow

Fee paid

Approval 9D(2C) decision

Acknowledgement Email sent to sponsors

TRIM filing Acknowledgement email and attached data

Write to ARTG Changes and comments

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E-form - searching for your goods

¤ Search by active ingredient ¡ Search by ARTG ID

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E-form - selecting your goods

Available ARTG entries R ARTG ID 12345 MEDINAME1 paracetamol 500mg R ARTG ID 54321 MEDINAME2 paracetamol 300mg R ARTG ID 11111 MEDIBRAND paracetamol 300mg

ARTG entries selected for variations

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E-form – selecting a notification

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E-form – provide legal assurances for notifications

E-form - validate changes

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Attach supporting Information

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Summary of changes and associated fees

*Fees above are for the 2016/2017 financial year 11

Print Preview

11111, 12345

*Fees above are for the 2016/2017 financial year 12

Minor variations guidance Changes and improvements

• Notifications will be incorporated into the minor variations guidance: – The minor variations process – Appendix 1: Chemical entities change codes – Appendix 2: Biological medicines change codes

• Updating hardcopy change code appendices to improve the table of contents layout

• E-form FAQs

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Timing of implementation

Notifications – registered non-prescription

Prescription medicines e-form

Notifications - prescription medicines

July 2017 July 2017 4 December 2017 IT deployment: 1-3 December 2017

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Questions? Email: AET.application.entry.team@tga.gov.au

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