Notifications to prescription medicines Low risk changes that do not affect safety, quality or efficacy
Jenny Burnett Scientific Evaluation Branch Therapeutic Goods Administration ARCS Webinar 10 November 2017
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Notifications to prescription medicines
MMDR reforms
Notifications process
Updates to the minor
variations e-form
ARCS webinar: Notifications to prescription medicines
MMDR Reforms Risk-based approach to minor variations - notifications
All registered medicines: • OTC • Registered complementary medicines • Prescription (chemical and biological medicines)
Special mention: biologicals
Staged implementation
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Notifications process Human touch points
E-Form Invoice Paid ($$) Acknowledgement ARTG File
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The automated workflow
Fee paid
Approval 9D(2C) decision
Acknowledgement Email sent to sponsors
TRIM filing Acknowledgement email and attached data
Write to ARTG Changes and comments
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E-form - searching for your goods
¤ Search by active ingredient ¡ Search by ARTG ID
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E-form - selecting your goods
Available ARTG entries R ARTG ID 12345 MEDINAME1 paracetamol 500mg R ARTG ID 54321 MEDINAME2 paracetamol 300mg R ARTG ID 11111 MEDIBRAND paracetamol 300mg
ARTG entries selected for variations
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E-form – selecting a notification
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E-form – provide legal assurances for notifications
E-form - validate changes
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Attach supporting Information
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Summary of changes and associated fees
*Fees above are for the 2016/2017 financial year 11
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11111, 12345
*Fees above are for the 2016/2017 financial year 12
Minor variations guidance Changes and improvements
• Notifications will be incorporated into the minor variations guidance: – The minor variations process – Appendix 1: Chemical entities change codes – Appendix 2: Biological medicines change codes
• Updating hardcopy change code appendices to improve the table of contents layout
• E-form FAQs
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Timing of implementation
Notifications – registered non-prescription
Prescription medicines e-form
Notifications - prescription medicines
July 2017 July 2017 4 December 2017 IT deployment: 1-3 December 2017
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Questions? Email: [email protected]
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