TGA presentation: Prescription medicines minor variations e-Form: Information sessions, 3 and 5 July 2017

Presentation: New e-form for minor variations: Prescription medicines

21 July 2017

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The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Adrian Bootes, Felicity Jameson, Klara Koelmeyer, Karen Loft
  • Presented at: Sydney Northside Conference Centre, 3 July 2017, and Amora Hotel, Bridge Road, Melbourne, 5 July 2017
  • Presentation summary: Prescription medicines Minor Variation electronic form

Transcript

New e-form for minor variations: Prescription medicines

Adrian Bootes, Felicity Jameson, Klara Koelmeyer, Karen Loft
Medicines Regulation Division
Therapeutic Goods Administration

Prescription medicines minor variations e-Form: Information sessions. 3 and 5 July 2017

Slide 1 - Minor variations to prescription medicines

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

Slide 2 - Reducing regulatory burden

  • Need for improvements to processes
  • Staged approach to improve the processing of minor variations
  • Number of Minor Variations received in 2016-2017 financial year
    Category Number
    9D(1) 122
    Category 3 1345
    MEC 458
    SAR 1232
    SRR 707
    Total 3864

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 - Applicant/Client information

Screenshot of Step 1 Applicant information

Slide 5 - New Application

Screenshot of Applicant information

Slide 6 - Searching for your goods

Screenshot highlighting how to Add the goods you want to vary

Slide 7 - Searching for your goods

Screenshot of Step 2a Search for goods

Slide 8 - Selecting your goods

Screenshot of Step 2b Select goods

Slide 9 - Selecting your goods

Screenshot of Step 2b Select goods > ARTG entries selected for variations

Slide 10 - Creating a variation

Screenshot of Step 2c Variation

Slide 11 - Creating a variation (2)

Screenshot of Variation > Quality information

Slide 12 - Easy selection of Variation Types

Screenshot of list of variation types

Slide 13 - Variation type <Formulation>

Screenshot of Step 2d Variation details

Slide 14 - Variation type <Pack size and Poison schedule>

Screenshot of Step 2d Variation details > Help button and Complete variation button

Slide 15 - Validation results

Screenshot of Step 2 Make variation(s) > Validation results highlighting errors

Slide 16 - Warning results

Screenshot of Step 2 Make variation(s) > Validation results highlighting Warnings

Slide 17 - Known areas for development

  • Current known warnings
    • Manufacturer information
      • Link between ARTG and manufacturer database (MIS) - 'invisible' sites
    • Missing PAR details in existing ARTG entries
    • Quantity Sufficient (QS) in formulation
      • Value required (0 - QS)
  • Any others please tell us

Slide 18 - Summary of changes and associated fees before you submit

Screenshot of Step 3 Declaration and submit

Slide 19 - Submission number generated at point of submission

Screenshot of Step 3 Declaration and submit > Submission successful

Slide 20 - Print Preview (page 1)

Screenshot of Print Preview (page 1)

Slide 21 - Print Preview (page 2)

Screenshot of Print Preview (page 2)

Slide 22 - Next steps

  • Guidance updated and published - printable version and e-book
  • e-form launch - external stakeholders involved
  • Ongoing improvements - new 'notifications' process

Slide 23 - More information

Print version

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