New e-form for minor variations Prescription medicines Felicity - - PowerPoint PPT Presentation

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

• Need for improvements to processes
• Acknowledged in the Review of Medicines and

Medical Devices (MMDR) – Recommendation 13

• Staged implementation

Reducing regulatory burden

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New electronic form

• 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

First step for prescription medicines

New e-form for minor variations

Benefit

Easy to identify your ARTG entries

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Benefit

Easy selection of types of minor variations

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Benefit

Summary of changes and associated fees before you submit

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Benefit

Submission number generated at point of submission Enables provision of data via email at time of application

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Next steps

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

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More information

Prescription medicines reforms

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

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