TGA GMP clearance: making a listed medicine overseas

Which steps need a clearance

"All steps of manufacture of registered and listed products are required to be GMP compliant unless they are exempt", and each step must be recorded in the product's ARTG entry. For a listed medicine, the steps that need GMP evidence are:

• Making the dosage form: the capsule, tablet or powder itself.
• Packaging and labelling. Secondary packaging can need a clearance too, where that step is done for the product.
• Chemical and physical testing, and microbial testing.
• Release for supply: the batch certified by an authorised person.

Where a step happens overseas, the TGA's certification guidance for listed medicines says the manufacturer must hold a TGA GMP clearance, or a clearance the TGA accepts. The Australian sponsor applies for it, and certifies when it lists the medicine that its manufacturing meets the requirements. A clearance belongs to one site and one sponsor: "separate applications are required for each unique site address", and "each sponsor must obtain their own GMP Clearance for a particular manufacturing site". More on the sponsor's role in our TGA sponsor guide.

In Australia, a TGA manufacturing licence does the same job: "You need a TGA manufacturing licence to manufacture in Australia therapeutic goods for supply in or export from Australia", unless Schedule 7 of the Therapeutic Goods Regulations 1990 exempts the goods, or Schedule 8 exempts the person making them. More on manufacturing.

Three routes to a clearance

Route	When it applies	Who it can rely on
Mutual recognition agreement (MRA) desktop evaluation	The regulator inspected a manufacturer within its own borders	The European Union (with Norway, Iceland and Liechtenstein), the United Kingdom, Canada, Singapore and New Zealand; Switzerland under a memorandum of understanding
Compliance verification (CV) desktop evaluation	The regulator inspected a manufacturer outside its own borders, or works with the TGA under a cooperative arrangement	An MRA partner's inspection outside its own borders; Health Canada outside Canada; the US FDA, inside or outside the US; the EDQM outside the EU with an EU member state; and, in some cases, other PIC/S members' inspections within their own countries
TGA inspection	No acceptable evidence from another regulator	The TGA's own inspectors, requested through a certification application

For other regulators in PIC/S, the international GMP inspection scheme, the TGA doesn't accept evidence from an inspection performed outside that regulator's own country.

Why supplements often need an inspection

The two desktop routes rely on another regulator having inspected the site as a medicines manufacturer. The TGA says the MRA and CV pathways are unavailable for "some complementary and listed medicines, including sunscreens and dietary supplements", because they "may not be regulated as medicines in other countries": "The site must be inspected by a recognised regulatory authority for a human medicinal product". An older TGA guide puts it plainly: "It is often not possible to obtain GMP clearance using evidence from another regulator" for listed medicines.

There is one way through for a medicines plant. Where supplements are made "in the same facility under the same standard and controls" as the medicines its certificate covers, the TGA may accept a complementary medicine declaration with the site's most recent GMP certificate.

So a factory that makes supplements under food rules in its own country often can't be cleared on paper, and the options are a TGA inspection or a site that can be cleared.

The evidence for compliance verification

A CV application needs, among other documents:

• A GMP certificate from an overseas regulator "issued after an on-site inspection", and the most recent inspection report.
• A list of the regulators' on-site inspections in the three years before the application, and details of any regulatory action.
• The site master file, the list of products intended for supply, the GMP agreement, the release procedures, the validation master plan, the latest product quality review and, for a contract testing laboratory, the list of authorised tests.

Since 1 July 2025 the TGA has gone back to its pre-pandemic rule for CV applications: it no longer accepts evidence from an inspection more than three years old. An MRA evaluation rests on an MRA GMP certificate.

GMP clearance fees for 2026–27

Fee	Amount
GMP clearance application processing, per manufacturer, site and sponsor	$818
Obtaining evidence from an overseas regulatory authority, per manufacturer, site and sponsor	$880
Compliance verification, in lieu of an overseas GMP inspection	$3,130
Reinstating an expired GMP clearance, per manufacturer, site and sponsor, on top of the fees that apply	$1,479
Inspecting an overseas manufacturing site	$1,748 an hour per inspector, plus costs and reasonable expenses, including accommodation and allowances outside Australia

Which fees apply depends on the route and the evidence. The TGA charges no separate application fee for a GMP clearance, or for the certification of an overseas site, and the fees are set in Schedule 9 of the Therapeutic Goods Regulations 1990. The calculator in our TGA approval guide adds the processing fee to a whole plan's other TGA fees.

How long a clearance lasts, and renewing it

• No fixed term. The TGA sets each clearance's expiry date, and "may shorten the expiry date of your GMP Clearance depending on the level of compliance evaluated", or because of restrictions identified in the evidence.
• Renew early. A renewal is a variation application, and the TGA asks for it at least six months before the current clearance expires.
• Extensions are short and few. The TGA can grant a short-term extension for valid reasons, "usually no more than one extension" on top of the six months already applied to an issued clearance, and it gives priority to requests made more than a month before expiry.
• The 2025 backlog measures. MRA clearances and CV clearances for non-sterile active ingredients due to expire between 1 July 2025 and 30 June 2027 were extended by two years without an application: 6,258 extensions in all. The TGA's dashboard, with data from 1 June 2026, reports its queue of CV applications falling from 2,185 at the end of June 2025 to 1,203.
• Processing times. The TGA took target processing timeframes out of its guidance in November 2023; its GMP clearance dashboard now reports processing times, with a target for MRA applications.
• A new portal. The TGA has said new GMP clearances will be submitted through its new business services portal once it goes live, which it expected in mid to late 2026.

When a clearance lapses

• After 30 days, the sponsor can no longer submit variation applications for it.
• After 12 months, it can't be reinstated.
• No transfers. An expired clearance can't be transferred.
• The ARTG. The TGA can only update ARTG entries with current GMP clearances.
• Cancellation. The TGA can cancel, suspend, add conditions to or reduce the scope of a clearance, including where the sponsor doesn't meet its responsibilities.
• The medicine. If a listed medicine doesn't meet its certifications, "penalties can apply and in some cases we can remove your product from the ARTG", "making it illegal for you to continue selling or supplying in Australia."

The standard: the PIC/S Guide, version 17

From 1 September 2025, version PE009-17 of the PIC/S Guide to GMP (25 August 2023) applies to the manufacture of medicines, active pharmaceutical ingredients and sunscreens in Australia, unless they are exempt. Its Annexes 4, 5 and 14 are not adopted in Australia. It applies through the Therapeutic Goods (Manufacturing Principles) Determination 2020, as amended in 2025.

Where we come in

For a listed medicine, every step is made under the TGA licence or GMP clearance it needs; within that, we match on format, volume and margin. Overseas, the clearance is the sponsor's own, even where the factory already supplies other Australian brands. A site that can't be cleared changes the timeline and the cost, so we settle it when we choose the manufacturer, before the quote you approve. For an overseas brand coming to Australia, the clearance is one step of several: see bringing a supplement brand to Australia. We have managed manufacturing, imports and air freight through to delivery for Pump's hair supplement, imported ingredients, customs and freight for BWellness, and a whole cross-border supply chain from a New Zealand maker for Deeply Rooted. More on manufacturing, or book a call.