Executive summary
Australia and New Zealand have separate regulators — the TGA (Australia) and Medsafe (New Zealand) — with distinct legislative frameworks. Both require marketing authorisation for peptide drugs. Both offer pathways for access to unapproved medicines through special access schemes and personal importation. Compounding is permitted within strict boundaries.
Australia
Authorities and legal categories
TGA (Therapeutic Goods Administration): regulation under the Therapeutic Goods Act 1989 (Cth).
ARTG (Australian Register of Therapeutic Goods): therapeutic goods must generally be registered or listed unless exempt, excluded, or supplied under an applicable statutory pathway.
ACMS (Advisory Committee on Medicines Scheduling): prepares the Poisons Standard (SUSMP).
Key instruments:
Therapeutic Goods Act 1989 (Cth).
Poisons Standard (SUSMP).
Therapeutic Goods Advertising Code (No. 2).
Approved medicines
Peptide medicines registered on the ARTG include insulin analogues, GLP-1 receptor agonists (semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide), teriparatide, octreotide, leuprolide, goserelin, desmopressin, and calcitonin. Most are Schedule 4 (Prescription Only) under the SUSMP.
Source: https://www.tga.gov.au/resources/artg
Investigational use
Clinical trials require TGA notification or approval under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes.
Compounding/manufacturing
Extemporaneous compounding for an individual patient on prescription is exempt from ARTG entry under s. 18 of the Act, provided it is not conducted on a scale that makes it "like a manufacturer." The TGA's Compounding of Medicines: A Guide outlines the boundary.
Source: https://www.tga.gov.au/compounding
Import, sale, advertising, and online supply
Personal Importation Scheme: individuals may import up to 3 months' supply of an unapproved therapeutic good for personal use. The goods must be for the individual's own treatment or for a member of their immediate family, and a prescription from an Australian-registered doctor is required for prescription-only medicines. Routine TGA notification is not required for personal importation under this scheme.
Special Access Scheme (SAS): Categories A, B, C — for individual patients with medical need. Category B requires TGA notification/approval.
Authorised Prescriber Scheme: practitioners can apply to prescribe unapproved medicines to a class of patients.
Advertising: Prescription medicines (Schedule 4/8) cannot be advertised to the public. The Therapeutic Goods Advertising Code enforces against peptide vendors using social media or e-commerce platforms.
Sources:
Research-use-only products
A genuine laboratory reagent may fall outside therapeutic-goods regulation depending on intended use, presentation, claims, and supply facts; RUO wording alone is not dispositive. TGA has warned that "not for human consumption" labelling does not shield products marketed with therapeutic claims.
Enforcement examples and uncertainty
TGA has taken action against peptide suppliers marketing via social media and making human-use claims behind "not for human consumption" labels.
New Zealand
Authorities and legal categories
Medsafe (Ministry of Health): administers the Medicines Act 1981 and Medicines Regulations 1984.
Key instruments:
Medicines Act 1981.
Medicines Regulations 1984.
Approved medicines
Peptide medicines with Medsafe consent to distribute include GLP-1 receptor agonists, insulins, growth hormone, and other peptide therapeutics.
Source: Medsafe Product Search, https://www.medsafe.govt.nz/DbSearch/
Compounding
Pharmacy compounding is permitted under s. 25 of the Medicines Act for a named patient. Beyond extemporaneous scale, a manufacturing licence is required under the GMP Code.
Import
Personal import: up to 3 months' supply for prescription medicines, requiring a letter from a New Zealand-registered prescriber. Must be declared on arrival.
Importers under s. 25 can directly import for a named patient.
Source: https://www.medsafe.govt.nz/Consumers/MIET/ImportMedicines.asp
Research-use-only products
Similar to Australia: "research only" labelling is not a safe harbour. Therapeutic claims make the product a medicine requiring consent.
Practical interpretation limits
This is general regulatory research, not legal advice. Classification can turn on composition, claims, intended use, route, supplier role, and facts not captured by a product name.
Primary sources
Therapeutic Goods Act 1989 (Cth). https://www.legislation.gov.au/C2004A03952/latest/text
TGA Compounding Hub. https://www.tga.gov.au/compounding
TGA Personal Import. https://www.tga.gov.au/personal-importation-scheme
ARTG Search. https://www.tga.gov.au/resources/artg
Medsafe. https://www.medsafe.govt.nz
Medicines Act 1981 (NZ). http://www.legislation.govt.nz/act/public/1981/0118/latest/DLM53790.html
Medsafe Personal Import. https://www.medsafe.govt.nz/Consumers/MIET/ImportMedicines.asp