TGA presentation: Notifications to prescription medicines, 10 November 2017

Notifications to prescription medicines

10 November 2017

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Presentation

  • Presented by: Jenny Burnett
  • Presented at: ARCS webinar
  • Presentation date: 10 November 2017
  • Presentation summary: New notifications process for minor variations to prescription medicines

Transcript

Notifications to prescription medicines

Jenny Burnett
Scientific Evaluation Branch
Therapeutic Goods Administration

ARCS webinar – 10 November 2017

Slide 1 - Notifications to prescription medicines

  • MMDR reforms
  • Notifications process
  • Updates to the minor variations e-form

ARCS webinar: Notifications to prescription medicines

Slide 2 - 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

Slide 3 - Notifications process

Human touch points

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

Slide 4 - 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

Slide 5 - E-form - searching for your goods

A screenshot of Step 2a within the e-form where an applicant can search for their goods by active ingredient or by ARTG ID.Search for your goods

  • Search by active ingredient
  • Search by ARTG ID

Slide 6 - E-form - selecting your goods

A screenshot of Step 2b within the e-form where an applicant can select which goods are to be varied.

Slide 7 - E-form – selecting a notification

A screenshot of the step within the e-form where an applicant can select a notification as the variation category.

Slide 8 - form – provide legal assurances for notifications

A screenshot of the e-form where an applicant must provide legalassurances specific to the notification change.

Slide 9 - E-form - validate changes

A screenshot of the validation step within the e-form.

Slide 10 - Attach supporting Information

A screenshot of the step within the e-form where an applicant can chose how to send in their supporting information.

Slide 11 - Summary of changes and associated fees

A screenshot of the summary table within the e-form.

*Fees above are for the 2016/2017 financial year

Slide 12 - Print Preview

A screenshot of the section of the print preview that identifies the change type, supporting information and submission ID.

*Fees above are for the 2016/2017 financial year

Slide 13 - 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

Slide 14 - Timing of implementation

Notifications – registered non-prescription – July 2017

Prescription medicines e-form – July 2017

Notifications - prescription medicines – 4 December 2017

IT deployment: 1-3 December 2017

Slide 15 – Questions?

Print version

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