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Australia’s GMP mirage: why ‘EU-GMP equivalent’ fails the global cannabis test

Aug. 26, 2025 by SOMAÍ Pharmaceuticals

SOMAÍ chairman and interim CEO Michael Sassano says many Australian producers have work to do before they can compete on the global stage.

The debate over the equivalence of Australian Good Manufacturing Practices (AU GMP) and European Union GMP (EU-GMP) continues, but the market tells a clear story. While a mutual recognition agreement exists on paper, the written rules are similar and there is a strong international presence for Australian big pharmaceuticals, the reality for cannabis producers is that AU GMP-certified finished cannabis dosage forms are consistently absent from European and other global markets.

Achieving a GMP certification signifies meeting a minimum standard; it does not guarantee a level of access to the world’s most stringent markets. The persistent failure of Australian cannabis products to penetrate these markets reveals a critical gap between theoretical standards and practical enforcement.

The geographic reality: a one-way street for cannabis products

The most compelling evidence in this debate is geographic. Australian-made, GMP-certified finished dosage cannabis products have not been sold in significant quantities to any global market outside of Australia. While some Active Pharmaceutical Ingredients (APIs) are sold to Germany to compound pharmacists or used in UK repackaging schemes, the core finished dosage form products remain landlocked.

This fact alone should end the discussion, but the discrepancy is highlighted by Australia’s open-door policy. Australia recognises and accepts cannabis products from countries like Canada and South Africa, yet those same countries cannot sell their finished products into the EU. This creates a one-way flow where international producers can “dump” products of varying quality on the Australian market, often to be repackaged by white-labellers and branded as local.

The proof is in the results: there are no significant sales of Australian-made finished dosage forms to other countries, including its neighbour New Zealand. This is not an accident; it is a reflection of the quality standards of those cannabis producers and not the real pharmaceutical GMP – which does exist for large Australian pharma players.

Source materials: a crisis of consistency

One primary reason for this quality gap lies in the management of source materials. EU-GMP standards, guided by the regularly updated EU herbal pharmacopeia, place strict requirements on source materials and stability testing for all pharmaceuticals.

Key differences in practice include:

  • Stability testing: EU-GMP demands new or concurrent stability testing every time the source flower for an extract is changed. Any change in flower input fundamentally alters the final medicine. In contrast, many Australian and Canadian producers change source materials, or their suppliers do not have consistent inputs regularly and avoid this rigorous validation.
  • Batch-to-batch consistency: consequently, very few Australian extracts can prove batch-to-batch consistency in their minor cannabinoid or terpene profiles. There is a lack of regulatory oversight to ensure these standards are met, unlike in the EU.
  • Minor cannabinoids: the EU herbal pharmacopeia limits synthetically produced and purified minor cannabinoids. As an example, CBN, rightly or wrongly, is considered a degradation product of THC and the EU does not permit the use of purified or synthetically produced minor cannabinoids. Many Australian products, however, use minor cannabinoids created through chemical processes, a direct contradiction of the EU pharmacopeia herbal standards they claim to follow.

An EU-qualified person (QP) would reject products with such inconsistencies, yet this practice continues in Australia under a special access scheme. And although it’s great for consumers to get these novel formats, there is no monograph in the EU for any minor cannabinoids and a strict ban on chemically synthesized and separated minors.

Regulatory blind spots: timelines, facilities, and enforcement

The differences in regulatory enforcement are stark. Bringing a new product to market under EU-GMP is a meticulous process of documentation that takes a minimum of two-and-a-half years from equipment purchase to final release. In Australia, companies appear to launch new products almost overnight, often “chasing stabilities” after the product is already on the market.

This lack of enforcement extends to the production facilities themselves:

  • Compounding pharmacies: regulators have failed to close loopholes that allow some AU GMP facilities to operate at a standard barely distinguishable from a glorified compounding pharmacy.
  • Equipment standards: a walk through many Australian cannabis facilities reveals non-pharmaceutical grade equipment. The simple presence of paint on equipment, which is considered a contaminant and strictly forbidden under GMP, is common.
  • Basic GMP violations: simple GMP rules, such as avoiding clear packaging glass that exposes medicine to light and causes degradation, are often ignored and remain unchecked.

Regulators know these rules but are not enforcing them for the cannabis industry, whereas EU regulators are far more stringent.

A standard on paper is not a standard in practice

While top-tier international pharmaceutical players in Australia certainly perform to global standards, the local cannabis industry is a clear exception. The inability of Australian-made finished cannabis products to enter foreign markets is direct evidence that “AU GMP” is not functioning as the equivalent of EU-GMP.

The problem is not the written standard itself but a widespread lack of enforcement and, most importantly, a level of paperwork. Until regulators hold cannabis producers to the same stringent rules outlined in the pharmacopeia – demanding batch-to-batch consistency, proper stability testing, and adherence to facility standards – Australia’s cannabis industry will remain isolated, and its claims of “EU-GMP equivalence” will continue to ring hollow.

This article was originally published in Cannabiz.