Industry feedback requested on e-form and managing variations in registered medicines

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The Therapeutic Goods Administration (TGA) is working to implement an electronic application form for prescription medicines and a notification process for very low-risk changes to registered medicines, and is seeking feedback from industry stakeholders.

The TGA expects to launch an e-form in the coming weeks for submitting prescription minor variations applications. The e-form, replacing six paper forms, is designed to decrease time and effort.

As well as introducing the e-form, the TGA will update prescription minor variations guidance documents, including:

  • Minor variations to prescription medicines – process guidance;
  • Appendix 1: Variation change types – chemical entities; and
  • Appendix 2: Variation change types – biological medicines.

These documents are open for consultation and members can contact AusBiotech to view these documents. Finalised versions of these documents will be available on the TGA website in print and e-book format following this consultation period.

The TGA is also seeking feedback on a new notification process for low risk variations to registered medicines and a second set of changes proposed as notifications, following industry review of the initial set in late 2016.

These will enable companies to electronically advise the TGA of changes to their products. While the system will support automated approvals, companies must advise the TGA prior to implementing any changes.

The TGA will implement the updated processes in stages and it is anticipated the automated notifications process will be launched in July 2017 and the new e-form for prescription medicines to be updated by the end of 2017.

Members are invited to contact AusBiotech to view these updated documents and submit feedback to / 03 9828 1400 by Friday 7 July 2017. Enquiries regarding the e-form should be directed to the TGA.

This consultation is part of the Medicines and Medical Devices Review (MMDR) and the TGA’s effort to implement a more risk-based approach for managing registered medicines variations.