Good Manufacturing Practice in Australia

The two regimes are built the same way: you need a site licence for each manufacturing step, you must follow manufacturing principles, and both have statutory licence conditions and fit-and-proper tests. Where they differ is who sets the GMP standard and how much is written into the law itself. The TGA's standard is a ministerial instrument that adopts the PIC/S Guide (from the previous answer). For veterinary products, the APVMA sets its own manufacturing principles, and the Agvet Regulations require licensees to follow the APVMA's own Australian GMP Code. The Regulations also spell out record-keeping, audit and subcontracting rules directly. The APVMA scheme also covers fewer products: agricultural chemicals and many low-risk veterinary products need no manufacturing licence at all.

Side-by-side

Point	TGA (Therapeutic Goods Act 1989, compilation 89, 5 Sep 2025)	APVMA (Agvet Code compilation 34, 14 Oct 2024; Agvet Regulations compilation 49, 1 Oct 2025)
Who sets the principles	The Minister "may" determine them for goods "for use in humans"; they may include GMP codes and are legislative instruments [1]	The APVMA determines them under s 23 of the Agricultural and Veterinary Chemicals Act 1994 [8]. Licensees "must" manufacture in line with the manufacturing principles and the Australian GMP Code, meaning the APVMA's Australian Code of GMP for Veterinary Chemical Products (reg 61(3A); reg 3) [9][10]
GMP standard used	PIC/S Guide PE 009-17, adopted by the Manufacturing Principles Determination 2020 (Federal Register of Legislation)	The APVMA's own code (see row above)
Products outside the licensing scheme	Exempt goods and exempt persons, set in the regulations [2]	Part 8 does not apply to: listed and reserved chemical products; all agricultural chemical products; some ingredients; research and pilot-plant products; dilute non-sterile homeopathics; skin cleansers and shampoos; coat conditioners; hoof protectants; sheep branding substances; and listed stockfood additives (reg 59) [11]
How a licence is structured	Covers specified steps for specified goods at each site [4]	Risk-based categories (definitions in reg 3) [10]: • Cat 1: sterile or immunobiological products • Cat 3: external ectoparasiticides • Cat 4: premixes and stockfood supplements • Cat 6: only certain steps (processing, packaging, labelling, storage, sterilising, testing, release) • Cat 2: everything else • Multi-category licences also exist
Penalty for manufacturing without a licence	Up to 5 years' imprisonment or 4,000 penalty units where harm results or is likely; 12 months or 1,000 units otherwise; 100 units strict liability [2]	240 penalty units (strict liability), and it is also a civil penalty provision. Breaching a licence condition is 120 units (s 121) [12]. Infringement notice amounts depend on the licence category [13]
Grounds for refusing a licence	Unable to comply with the principles; unsatisfactory site; s 9K prohibitions; fit-and-proper tests looking back 10 years [4]	Similar 10-year tests, plus failing to comply with a manufacturing principle in the previous 5 years (s 123(1)(f)) [14]. If directed, the applicant must undergo a pre-licence audit (reg 59E) [15]
Conditions every licence carries by law	Meet standards; observe the principles; report information on harm, efficacy or quality; allow entry, questioning, and access to documents and samples (s 40(4)) [5]	Meet standards; allow inspectors in to use monitoring powers; comply with conditions set in the regulations (s 126(4)) [16]

Extra detail in the APVMA Regulations (reg 61)

These apply to every APVMA licence ^[9]:

• Records: you must keep records of materials and suppliers, process controls, product tests, stability studies, and complaints or product failures.
• Batches: each batch needs a batch number.
• Retention: keep records and, where reasonable, batch samples on site for at least 12 months after expiry. If there is no expiry date, keep them for 6 years after manufacture was completed.
• Nominated person: the person you nominate to control production or quality control must keep that control. If you replace them, you must tell the APVMA their name, qualifications and experience (reg 62) ^[17].
• Subcontracting: allowed only to APVMA-licensed sites, or to overseas sites the APVMA has found meet a comparable standard (reg 61(7A)). A contractor doing packaging, labelling or testing must be supervised, and responsibilities must be recorded in writing.
• GMP audits: these happen when the APVMA CEO directs. You must notify a critical non-conformance in writing within 3 working days and submit the signed audit report with a corrective action plan.

Other APVMA-specific points

• Single-step exemption: someone who only packages, labels, analyses or tests is exempt if another person's licence permits it. Applying only a name, address or registration number label is also exempt (reg 59A) ^[18].
• Overseas manufacturers: handled through a condition on the product's registration rather than a licence. If directed, the registrant must provide GMP evidence, such as audit reports, which the APVMA then assesses (reg 71B) ^[19].
• Fees: $900 to apply. Annual fees are $7,500 (category 1 or multi-category), $5,000 (categories 2 to 4) and $1,800 (category 6), with a 50% reduction from the second year if the notional wholesale value is under $50,000 ^[20].

Medical devices have no equivalent on the APVMA side. Under the TGA they follow conformity assessment procedures (quality management systems, certification, monitoring) rather than manufacturing principles ^[6].

Approach: I compared Part 3-3 of the Therapeutic Goods Act with Part 8 of the Agvet Code and the Agvet Regulations. I did not read the text of the APVMA's Australian GMP Code or its s 23 manufacturing principles instrument, or the TGA's rules on overseas manufacturers and fees, so the table does not compare those.

Which register you check depends on what the manufacturer makes. For veterinary chemical products, I can search the APVMA's list of licensed manufacturers right here: the copy I searched holds 154 current licences. Each one gives the licence number, holder, site address, licence category and the manufacturing steps it covers. For human therapeutic goods, the TGA publishes its own list of licensed Australian manufacturers. That list is not in our datasets, and the TGA website timed out when I tried to open it.

Veterinary products (APVMA list) You can search by licence number, holder name, address, product category or manufacturing step. Two examples from the list:

• Licence 1112, Vetlab Sterile Pty Ltd, North St Marys NSW. Category 1 (sterile products). Steps include formulation, aseptic filling, heat and filtration sterilisation, packaging, labelling, physical testing, storage and release for supply ^[21].
• Licence 6199, Wesley Community Services Limited, Dundas NSW. Category 6 (all non-sterile and sterile dosage forms). It covers only secondary packaging, secondary labelling, physical testing and storage ^[22].

Finding the company's name is not enough. Check that its licence covers the right product category and the step it actually carries out, at that address. In the 6199 example above, the licence does not cover formulation or release for supply.

A missing name does not always mean the company is operating unlawfully:

• Exempt products: Part 8 does not apply to agricultural chemical products, listed and reserved chemical products, and several low-risk veterinary products (reg 59) ^[11].
• Single-step operators: a business that only packages, labels, analyses or tests is exempt if another person's licence permits that step (reg 59A) ^[18].
• Overseas manufacturers: they hold no Australian licence. Their GMP evidence is dealt with through a condition on the product's registration (reg 71B) ^[19].

If you give me a company name or licence number, I can look it up now.

Human therapeutic goods (TGA)

• The licence: it covers specified manufacturing steps for specified goods at a specified site ^[4]. Match all three when you check.
• Where to look: the official TGA pages are List of licensed manufacturers in Australia and TGA Business Services databases. Neither would open, so I can't tell you what they contain or how the search works.
• Overseas sites: they need TGA GMP clearance or certification, not an Australian licence. The TGA user guide Australian manufacturing licences and overseas GMP certification also would not open.
• Licence decisions: I found no grant, suspension or revocation notices in the captured TGA news feed.

Approach: I searched the APVMA licensed manufacturers list and the captured TGA news and medical device guidance. The TGA licensed manufacturer register is not in our datasets, and the TGA website did not respond, so the TGA links above are the official pages, not ones I could read.