New e-form for minor variations Prescription medicines Adrian Bootes, Felicity Jameson, Klara Koelmeyer, Karen Loft Medicines Regulation Division Therapeutic Goods Administration 3 rd July 2017 - Sydney 5 th July 2017 - Melbourne
Minor variations to prescription medicines New electronic form How will it help you apply for minor variations Next steps
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 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 3
Applicant/Client information 4
Searching for your goods 6
Searching for your goods 7
Selecting your goods 8
Selecting your goods 9
Creating a variation 10
Creating a variation (2)
Easy selection of Variation Types
Variation type <Formulation>
Variation type <Pack size and Poison schedule>
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 17
Summary of changes and associated fees before you submit
Submission number generated at point of submission
Print Preview (page 1)
Print Preview (page 2)
Next steps Guidance updated and published - printable version and e-book e-form launch - external stakeholders involved Ongoing improvements - new ‘notifications’ process 22
More information Prescription Medicines Authorisation Branch Application Entry Team AET.application.entry.team@health.gov.au 23
Recommend
More recommend
