TGA presentation: Industry, Sydney, 25 May 2017

New e-form for minor variations

5 June 2017

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Presentation

  • Presented by: Felicity Jameson, Jola Samoc
  • Presented at: Industry presentation, Sydney
  • Presentation date: 25 May 2017
  • Presentation summary: To provide prescription medicines regulatory affairs personnel with information on development of the new minor variations e-form.

Transcript

New e-form for minor variations

Felicity Jameson, Klara Koelmeyer, Jola Samoc
Medicines Regulation Division, Therapeutic Goods Administration

: Industry presentation, Sydney, 25 May 2017

Slide 1 - Minor variations to prescription medicines

  • New electronic form
  • How will it help you apply for minor variations
  • Next steps

Slide 2 - Reforms context

Reducing regulatory burden

  • Need for improvements to processes
  • Acknowledged in the Review of Medicines and Medical Devices (MMDR) -
  • Staged implementation

Slide 3 - New electronic form

First step for prescription medicines

  • One-stop shop: Consolidating six paper forms into one electronic portal
  • Reduced time and effort in making minor variations applications
  • More efficient processing of requests

Slide 4 - Benefit

Easy to identify your ARTG entries

screenshot1ADD IMAGE

Slide 5 - Benefit

Easy selection of types of minor variations

screenshot2ADD IMAGE

Slide 6 - Benefit

Summary of changes and associated fees before you submit

screenshot3ADD IMAGE

Slide 7 - Benefit

Submission number generated at point of submission

screenshot4ADD IMAGE

Slide 8 - Next steps

  • e-form testing
    • External stakeholders involved
  • e-form launch
    • After successful testing
  • Guidance updated and published
    • Printable version and e-book
  • Ongoing improvements
    • New 'notifications' process - pending new legislation

Slide 9 - More information

Prescription medicines reforms

https://www.tga.gov.au/prescription-medicine-regulatory-reforms

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