TGA Reporting for Medicinal Cannabis: What Every Business Needs to Know - Part Two 

Written By Rytasha Sekhon

The Therapeutic Goods Administration (TGA) has made it clear that compliance in the medicinal cannabis sector must continue to be prioritised (TGA, n.d). With clinics, prescribers, and wholesalers having strict obligations, the regulatory safety net requires coordination from every stakeholder in the supply chain including importers, pharmacies, manufacturers and sponsors.

In this second instalment of TGA Reporting for Medicinal Cannabis - What Every Business Needs to Know, we will explore the specific reporting and record-keeping responsibilities of importers, pharmacies, and manufacturers—and how these roles maintain the transparency and safety of Australia's medicinal cannabis industry.

Importers

Importing medicinal cannabis into Australia involves navigating a rapidly changing regulatory environment, where importers must satisfy the requirements of both the TGA and the Office of Drug Control (ODC).

While the ODC manages the overarching licenses and import permits, the TGA oversees the quality and safety of the therapeutic goods themselves (ODC, n.d.-a; TGA, n.d). Importers are required to maintain meticulous records of every shipment, including exact volumes, product specifications, and the corresponding permits (ODC, n.d). Further, importers must report any discrepancies, losses, or thefts immediately. Failure to maintain accurate import and distribution records not only jeopardises ODC licenses but can also trigger TGA compliance actions if the provenance of the medicine cannot be fully traced.

Pharmacies and Dispensaries

Pharmacists are the final stakeholder a patient must engage with prior to receiving their medicinal cannabis product(s), making their record-keeping responsibilities critical.

With the majority of medicinal cannabis products being unapproved medicines, pharmacies must ensure they only dispense medications when a valid TGA approval pathway (such as an SAS-B or Authorised Prescriber approval) and a legal prescription are in place (TGA, n.d).

As such, pharmacies are obligated to:

  1. Report dispensing data in accordance with both federal and state/territory specific regulations (which often involve real-time prescription monitoring systems). 

  2. Maintain comprehensive controlled drug registers 

  3. Medicinal cannabis products are classified as Schedule 4 or Schedule 8 medicines.

  4. Keep strict documentation regarding the receipt, storage, dispensing and the destruction or return of expired, unusable or unused products.

Manufacturers

Manufacturers bear the responsibility of ensuring that every batch of medicinal cannabis meets strict quality and safety standards before it can be released to the market.

Under Good Manufacturing Practice (GMP) guidelines, manufacturers must generate and retain extensive documentation for every step of the production process. This includes:

  • Batch Manufacturing Records: Detailed logs of raw materials, processing steps, and environmental controls.

  • Quality Control (QC) Testing: Certificates of Analysis (CoA) must be kept on file, proving the product meets its stated specifications for active ingredients and is free from contaminants like heavy metals or pesticides.

  • Stability Reporting: Manufacturers must conduct and record ongoing stability testing to justify the product's assigned shelf life.

If a quality defect is identified after being released in the market, it is the Sponsor’s responsibility to enable swift recalls, product testing and any required reporting to protect both patients' wellbeing and safety and the brand’s reputation. 

The Ongoing Role of Sponsors 

As mentioned in our previous article, sponsors act as the legal entity responsible for products in Australia. While manufacturers produce the goods and some products are sourced locally, importers bring them into Australia the sponsor ultimately holds the responsibility of reporting to the TGA once products are in market. Furthermore, sponsors must continuously liaise with their manufacturing and importing partners to ensure six-monthly supply reports and pharmacovigilance (adverse event - AEs) reports are accurate and submitted on time (ODC, n.d).

Looking Ahead

From the manufacturing floor to the pharmacy counter, every stakeholder in Australia’s  medicinal cannabis supply chain holds a piece of the compliance puzzle. As the industry matures, the TGA and federal / state health departments are increasingly sharing data and closing reporting loopholes. Businesses that treat record-keeping and reporting as a strategic priority, rather than an administrative afterthought will be best positioned for sustainable growth.

Learn More

EQWELLIBRIYUM offers end-to-end consulting for organisations navigating the medicinal cannabis market in Australia. With strategic insights and operational frameworks designed to help you thrive, we’re here to help you. Learn more by contacting us today at hello@eqwellibriyum.com.


Reference

Rytasha Sekhon
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