New e-form for minor variations Prescription medicines Felicity Jameson, Klara Koelmeyer, Jola Samoc Medicines Regulation Division Therapeutic Goods Administration 25 May 2017
Minor variations to prescription medicines New electronic form How will it help you apply for minor variations Next steps New e-form for minor variations
Reforms context Reducing regulatory burden • Need for improvements to processes • Acknowledged in the Review of Medicines and Medical Devices (MMDR) – Recommendation 13 • Staged implementation New e-form for minor variations 2
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 New e-form for minor variations
Benefit Easy to identify your ARTG entries New e-form for minor variations 4
Benefit Easy selection of types of minor variations New e-form for minor variations 5
Benefit Summary of changes and associated fees before you submit New e-form for minor variations 6
Benefit Submission number generated at point of submission Enables provision of data via email at time of application New e-form for minor variations 7
Next steps External stakeholders involved e-form testing After successful testing e-form launch Guidance updated and Printable version and e-book published New ‘notifications’ process – pending new legislation Ongoing improvements New e-form for minor variations 8
More information Prescription medicines reforms https://www.tga.gov.au/prescription-medicine-regulatory-reforms New e-form for minor variations 9
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