Prescription medicines Minor Variation electronic form

1. New e-form for minor variations
Prescription medicines
Adrian Bootes, Felicity Jameson,
Klara Koelmeyer, Karen Loft
Medicines Regulation Division
Therapeutic Goods Administration
3rd July 2017 - Sydney
5th July 2017 - Melbourne

2. Minor variations to prescription medicines
New electronic form
How will it help you apply for
minor variations
Next steps

3. 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
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4. 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
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5. Applicant/Client information
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7. Searching for your goods
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8. Searching for your goods
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9. Selecting your goods
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10. Selecting your goods
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11. Creating a variation
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12. Creating a variation (2)

13. Easy selection of Variation Types

14. Variation type <Formulation>

15. Variation type <Pack size and Poison schedule>

18. 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
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19. Summary of changes and associated fees before you
submit

20. Submission number generated at point of submission

21. Print Preview
(page 1)

22. Print
Preview
(page 2)

23. Next steps
Guidance updated and published - printable version and e-book
e-form launch - external stakeholders involved
Ongoing improvements - new ‘notifications’ process
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24. More information
Prescription Medicines Authorisation Branch
Application Entry Team
AET.application.entry.team@health.gov.au
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