Regulatory Credentials

Licensed. Audited. Compliant.

Cannexx holds a comprehensive suite of regulatory licences issued by Australian federal and state authorities. Every licence is actively maintained and subject to ongoing audit.

Our Regulatory Framework

Operating in the pharmaceutical sector demands the highest standards of regulatory compliance. Cannexx has invested significantly in obtaining and maintaining the full suite of licences required to manufacture, package, store, distribute, import, and export pharmaceutical products in Australia.

Our licences span federal and state jurisdictions, covering controlled substances, narcotic drugs, therapeutic goods manufacturing, and international trade. Each licence is subject to regular audit by the issuing authority.

FederalManufacturing

Therapeutic Goods Administration (TGA)

GMP Licence

Legislation: Therapeutic Goods Act 1989

Cannexx holds a current Good Manufacturing Practice (GMP) licence issued by the Therapeutic Goods Administration. This licence confirms that our manufacturing and packaging operations meet the standards set out in the Australian Code of GMP for Medicinal Products. GMP compliance is verified through scheduled and unannounced TGA inspections.

Covers all pharmaceutical packaging operations
Subject to TGA scheduled and unannounced inspections
Aligned with PIC/S GMP standards

FederalInternational Trade

Office of Drug Control (ODC)

Import & Export Licence

Legislation: Narcotic Drugs Act 1967 / Therapeutic Goods Act 1989

Cannexx is an authorised importer and exporter of pharmaceutical substances under licences issued by the Office of Drug Control. This authorisation permits the international movement of controlled and regulated pharmaceutical substances in compliance with Australia's obligations under international drug control conventions.

Authorised for import and export of controlled substances
Compliant with UN drug control conventions
Permits issued per shipment as required by ODC

State — VictoriaStorage & Distribution

Victoria Department of Health

Schedule 4 & Schedule 8 Licence

Legislation: Drugs, Poisons and Controlled Substances Act 1981 (Vic)

Cannexx is licensed by the Victoria Department of Health for the storage and distribution of Schedule 4 (Prescription Only Medicine) and Schedule 8 (Controlled Drug) substances. This state-level licence operates alongside federal TGA and ODC authorisations to ensure full compliance across all regulatory layers applicable to controlled pharmaceutical products in Victoria.

Schedule 4: Prescription Only Medicines
Schedule 8: Controlled Drugs
Compliant with Victorian poisons legislation

Our Compliance Commitment

Regulatory compliance is not a checkbox at Cannexx — it is embedded in every process, procedure, and decision we make. Our quality management system is designed to ensure that every product we handle meets the requirements of the applicable regulatory framework.

We maintain open and transparent relationships with all regulatory authorities, proactively engaging with auditors and inspectors to demonstrate our ongoing commitment to the highest standards of pharmaceutical manufacturing and packaging.

Regulatory Enquiries

For questions about our licences, compliance status, or to request documentation for due diligence purposes, contact our regulatory affairs team.