Supplying Medicines and Supplements to Australia

Australia rewards products already approved by a trusted regulator. An Australian sponsor holds the ARTG entry, and the TGA's comparable overseas regulator routes can cut review to 120 or 175 working days. Every overseas site needs TGA GMP clearance first. The PBS then decides public subsidy, and named-patient routes bring unapproved medicines to patients before registration.

Australia is also a well-documented source. Commercial exports must be on the ARTG, either approved for local supply or listed as export only, and the TGA issues WHO-format certificates of pharmaceutical product. Complementary medicines made in Australia can carry a Certificate of Listed Product, which helps buyers sourcing vitamins and supplements.

Australia at a glance

How to supply medicines to Australia

1. Appoint an Australian sponsor. The sponsor applies for the ARTG entry and is legally responsible for the product. An overseas maker needs a local subsidiary or a third-party sponsor. Our Japan, Korea, Australia and New Zealand guide explains the role.
2. Pick your route. If the FDA, EMA, MHRA, Health Canada, PMDA, HSA or Swissmedic has approved an identical product within the last year, COR-A takes 120 working days. COR-B (175) allows some extra data. Otherwise file a standard CTD. Our dossier and registration service can help.
3. Get GMP clearance for every overseas site. The sponsor applies, using the MRA pathway or compliance verification. If neither works, a TGA inspection can take up to 15 months, so start early and renew at least six months before expiry. Keep your GDP records ready too.
4. Apply for PBS listing. Sponsors apply to the PBAC for subsidy, based on TGA-approved indications. When the first new brand of a bioequivalent or biosimilar medicine is listed, the price drops by up to 25%. Watch medicines going generic for upcoming openings.

Doctors can use an unapproved medicine through the Special Access Scheme (Category A for seriously ill patients, B with TGA approval, C for products with an established history of use) or the Authorised Prescriber scheme. Sponsors supplying under these routes file six-monthly supply reports. See named-patient and special import and government tender supply.

Sourcing from Australia

• Originator medicines and comparators. Commercial exports must be on the ARTG and are made by the sponsor or an agent it authorises. For trial comparators, buy through the sponsor or a licensed wholesaler and ask for batch documents. See our comparator supply service and comparator sourcing guide.
• Export-only and contract manufacturing. Australian manufacturers need a TGA manufacturing licence, and a product made only for export can be listed on the ARTG as Export Only, which means it can't be supplied in Australia. See our CDMO guide and white-label manufacturing.
• Complementary medicines and supplements. Vitamins and supplements made for the Australian market are usually listed medicines made in TGA-licensed plants. For export, the TGA can issue a Certificate of Listed Product confirming free sale in Australia. See our nutraceutical sourcing.
• Export certificates. The TGA issues a WHO-format certificate of pharmaceutical product for registered medicines, a CPP for Export Only medicines, and batch certificates for some biologicals. The sponsor or its agent applies, and the certificate states that the listed manufacturers hold current GMP. See our CoPP guide.

Supplements

Most vitamins and herbal supplements are complementary medicines regulated by the TGA: listed (AUST L) medicines may only contain permitted low-risk ingredients and use permitted indications, with the sponsor certifying this, while registered (AUST R) ones are fully evaluated. Sports foods such as protein powders sit under Standard 2.9.4 of the Food Standards Code, but since 30 November 2020 certain sports supplements count as medicines, depending on ingredients, claims and form. Keep disease claims off the pack. We help brands get supplements made under their own label by GMP-certified contract manufacturers: see nutraceutical private label.

What people in Australia search for

Semrush data from October 2026 shows that people in Australia search most for creatine (about 110,000 searches a month), magnesium glycinate (74,000), protein powder (60,500), vitamin D (49,500) and creatine monohydrate (40,500).

Australians search for medicines by generic name too: pantoprazole gets about 17,500 searches a month, iron 15,680, melatonin 13,700 and amlodipine 10,900.

How importers, pharmacies and manufacturers in Australia search

GMP is a big theme: “good manufacturing practice pharmaceutical” gets about 1,900 searches a month, and “contract manufacturing” about 320.

Originator brands searched by name include Mounjaro (tirzepatide), Ozempic (semaglutide) and Wegovy (semaglutide). Brand names are trademarks of their owners and are used only to identify the medicine.

Supplements we can help you make

Often searched medicines include tirzepatide, semaglutide, pantoprazole and amlodipine. Some examples we list:

Documents to ask your supplier for

• A Certificate of a Pharmaceutical Product (CoPP) in WHO format.
• The plant's GMP evidence, such as a WHO-GMP, EU-GMP or PIC/S certificate, plus any inspection by your regulator.
• The registration dossier (CTD or ACTD), with bioequivalence data for generics where required.
• Stability data for hot climates.
• A Certificate of Analysis for every batch.

Not sure a supplier is genuine? Read how to verify a pharmaceutical supplier. For the neighbouring markets, see our Japan, South Korea, Australia and New Zealand import guide.

Frequently asked questions