Australia · Therapeutic Goods Administration · Combination products
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
3 requirements
Application fee
-
There is no separate combination product route. The principal therapeutic effect decides whether the product follows the medicine, device or biological route. Integral single-use drug delivery products, such as auto-injectors, are usually regulated as medicines. Devices with an ancillary medicine, such as heparin-coated catheters, are usually regulated as devices. Products that combine a medicine, device or biological component.
1. Find the principal therapeutic effect; 2. Apply through the matching route.
Outcome: The product follows the medicine, device or biological route that matches its principal effect.
Legal basis: Therapeutic Goods Act 1989, sections 3, 32A and 41BD (definitions of medicine, biological and medical device)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Australia: Registration of a new prescription medicine (standard pathway), Extension of indications and major variations of a registered prescription medicine, Registration of a new generic prescription medicine, Comparable overseas regulator report-based process, approach A, Comparable overseas regulator report-based process, approach B, Priority review pathway for prescription medicines, Provisional approval pathway for prescription medicines, Orphan drug designation, Access Consortium work-sharing, Project Orbis collaborative oncology review, Inclusion of a Class 2, 3 or 4 biological (cell and tissue products), Inclusion of Class I non-sterile, non-measuring devices and Class 1 IVDs. See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.