Australian listed medicines: what the sponsor certifies, and the evidence behind each statement
Listing relies on what the sponsor certifies, so build the evidence for each statement before you apply, and keep it after listing.
In Short
- Certify the 26A(2) matters with evidence.
- Use only permitted ingredients, indications.
- Report adverse information: s.29A.
Under section 26A(1) of Australia's Therapeutic Goods Act, the Secretary must list a medicine when the application meets the specified requirements, including the applicant's certifications under section 26A(2). This guide reads what the applicant certifies and the evidence each statement needs. The Act alone does not describe the wider TGA review workflow, so this guide does not. Opened: Therapeutic Goods Act 1989, Federal Register of Legislation compilation No. 89 (compilation date 5 Sept 2025, in force, no unincorporated amendments listed), sections 26A, 26BB, 26BF, 29A and 29AA. Law. Not opened: the Permissible Ingredients and Permissible Indications determinations themselves, the Therapeutic Goods Regulations 1990, the Therapeutic Goods Advertising Code, TGA guidance and web pages, PIC/S GMP and fees. TGA's AUST L and AUST L(A) labels were not checked against TGA pages. It is orientation, not legal advice. Sources checked 5 Oct 2026.
When the Secretary must list
Section 26A(1) says that when an application under section 23 meets the specified requirements, including the certifications in subsection (2) and the patent certificate under section 26B(1) or notice that one is not required, identified in 26A(1)(b), the Secretary must list the medicine. Subsection (1A) says the Secretary lists it without inquiring into the correctness of that certificate or notice; this no-inquiry language applies only to the section 26B patent certificate or notice, not to the 26A(2) certifications generally.
More on when the Secretary must list
The Act opened here does not describe how or when the TGA reviews sponsor evidence. Treat each certification as a statement you must be able to support with records on the day you sign it, and name who signs.
What the applicant certifies under 26A(2)
Section 26A(2) lists the certifications. They include that the medicine is eligible for listing and safe for its intended purposes; that its presentation is not unacceptable; that it conforms to applicable standards; that it complies with the Advertising Code and other advertising requirements; that Australian manufacturing steps were done by a licence holder; that its specifications and label meet prescribed requirements; that the applicant holds evidence its specifications will be maintained under the label's storage conditions until expiry; that all manufacturers are nominated; and that the information in the application is correct.
Evidence file behind the s.26A(2) certificate
More on what the applicant certifies under 26A(2)
Subsection (2A) allows further prescribed matters, which were not opened.
Ingredients and indications come from determinations
Section 26BB lets the Minister determine permissible ingredients and requirements for them. A listing applicant certifies under 26A(2)(ca) and (cb) that the medicine contains no ingredient outside that determination and breaches none of its requirements.
More on ingredients and indications come from determinations
Section 26BF does the same for indications, and 26A(2)(fba), (fd) and (fe) require every indication on the label and in the application to be covered. Under 26BF(2), the Minister may consider whether an indication relates to maintaining or enhancing health, preventing a dietary deficiency, or a non-serious form of a disease. The determinations were not opened here.
Manufacturing, overseas steps and stability evidence
For medicine made in Australia, 26A(2)(e) requires each manufacturing step to have been carried out by a licence holder. Under 26A(3), subject to the exemption in 26A(7), where a step happens outside Australia, the Secretary must have certified before the application that the manufacturing and quality control procedures for that step are acceptable; 26A(4) lists matters that may be considered, including attestations under recognised agreements; 26A(4A) adds a prior safety certification for ingredients of animal origin.
Where was each step made? (simplified s.26A)
- 26A(2)(e): each step by a licence holder, unless exempt.
More on manufacturing, overseas steps and stability evidence
26A(2)(fc) requires evidence that specifications will hold until expiry under labelled conditions. Keep manufacturer nominations, any written agreements required under 26A(2)(i), and stability data in one file per product.
After listing: evidence and adverse information
Listing does not end the duties. Under 26A(2)(j) and (ja), the applicant certifies that it holds evidence supporting every claim and indication, meeting any determination under 26A(2B).
Worked Example: Post-Listing Information Log for Product AU-118
| Information | 29A(2) kind | Decision |
|---|---|---|
| Customer reports rash after use | (b) possible harmful effect | Assess and notify in writing |
| Stability point below specification | (d) quality may be unacceptable | QA review, notify if confirmed |
| Supplier changes ingredient source | Not listed in 29A(2) | Change control; check other duties |
- Customer reports rash after use
- 29A(2) kind
- (b) possible harmful effect
- Decision
- Assess and notify in writing
- Stability point below specification
- 29A(2) kind
- (d) quality may be unacceptable
- Decision
- QA review, notify if confirmed
- Supplier changes ingredient source
- 29A(2) kind
- Not listed in 29A(2)
- Decision
- Change control; check other duties
More on after listing: evidence and adverse information
Under section 29A(1), once goods are listed, the person must tell the Secretary in writing as soon as it becomes aware of information that contradicts earlier information, suggests an unintended harmful effect, suggests the goods may be less effective than the listing suggested, or indicates unacceptable quality, safety or efficacy. Section 29A sets a criminal penalty and 29AA a civil penalty. People decide what is reported; record when information arrived and who decided.
Questions
What does section 26A(1A) cover?
Only the patent certificate required under section 26B(1), or the notice that one is not required, identified in 26A(1)(b): the Secretary lists without inquiring into its correctness. It does not say sponsor evidence for the 26A(2) certifications goes unreviewed; check the TGA's process separately.
Can we use any ingredient or indication?
No. Under 26A(2)(ca) to (fe), ingredients must be in the section 26BB determination and every indication covered by the section 26BF determination, meeting their requirements. Check the current determinations, which this guide did not open.
What if the medicine is made outside Australia?
Under 26A(3), the Secretary must have certified, before the application, that the manufacturing and quality control procedures for each overseas step are acceptable. 26A(4) lists matters that may be considered.
What must we report after listing?
Section 29A(1) requires written notice to the Secretary as soon as you become aware of the kinds of information in 29A(2), such as unintended harmful effects or unacceptable quality, safety or efficacy.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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