EU’s GMP Standard Guiding the Cannabis Industry Toward Global Legitimacy
By Oliver Bennett, Special Contributor to New Frontier Data
As global cannabis companies gird themselves for the opening of the lucrative European market, they know there is one significant obstacle to be overcome in order to be taken seriously – the European Union Good Manufacturing Practice (EU-GMP) certification.
Achieving the warranty is vital to get products into the legitimate European Union markets – indeed, also into non-EU markets, like the post-Brexit U.K. Without it, there is little chance for penetrating medical cannabis markets, and it is also becoming a quality control appellation for consumer CBD, after such negative indicators as a 2019 report which suggested that up to 70% of 240 CBD products available online could contain harmful impurities.
EU-GMP certification is mostly relevant for medical cannabis, where the demonstration of quality control is a must – which is why cannabis producers worldwide are now chasing EU-GMP certification as their priority. The Australia-headquartered and ASX-listed MGC Pharma, recently bruited as the first medical cannabis producer to float on the main board of the London Stock Exchange, has let it be known that the Australian Therapeutic Goods Association’s own GMP standards were recognised as complying with the EU’s GMP, explicitly stating that it would beat competitors who may have to get EU clearance. Roby Zomer, MGC Pharma’s chief executive, explained how the fact that some of the industry’s biggest international companies do not have EU GMP provides their GMP facility with a chance to overtake the competition into Europe.
All producers of scale need to gain the EU-GMP accreditation. Clever Leaves, the producer of medical cannabis whose operations in Colombia constitute 50% of that country’s quota – with exports to many European countries including Germany, Italy, the Netherlands, and the U.K. – gained EU-GMP certification in July 2020, claiming to be the first in Latin America to do so.
Avida Global, a U.K. company, has designed its state-of-the-art plant in Colombia with the purpose of gaining EU-GMP. The government of Cyprus recently announced that it had selected Israeli company Panaxia for its medical cannabis largely due to its EU-GMP certification, and the Mediterranean island nation of Malta – where cannabis seems soon due for legalisation – is now hosting Canadian-British firm Materia, with EU-GMP certification up front. It is important within European markets too, alongside national regulation: Aurora Nordic Cannabis has recently received EU-GMP certification and recognition by the Danish Medicines Agency.
The global drive for EU-GMP certification goes on, as it becomes central to the marketing of medical cannabis. It is the minimum requirement for manufacturers to meet, and involves achieving a set of criteria (e.g., hygiene standards and conditions for each documentation, personnel, equipment, batch history, and auditing) so that provenance and supply chain can be identified. It also addresses consumer-protection factors such as complaints and recall processes. In the end, EU-GMP is highly desirable for the growing medical cannabis market, which requires consistency as well as legitimacy in a European market expected to become the world’s largest space for legal cannabis, worth up to €123 billion by 2028.
The EU-GMP designation comes out of the EU’s classification of medical cannabis as a medical product, meaning that it must be manufactured and tested under formal conditions, including a listing in the Eudra Database European Medicines Agency – with an added measure being the Good Distribution Practices (GDP) certification for warehousing and distribution.
There are, of course, other international certification standards relating to cannabis production. Canada has its Good Production Practices (GPP) guidelines for medical cannabis, though some have asserted that EU-GMP guidelines are more thorough; moreover, Canadian companies still must apply for EU-GMP certification for European markets. The U.S. standard of Current Good Manufacturing Practice (CGMP) is more difficult to quantify as a standard since cannabis there remains illegal at the federal level.
To address the need for regulatory convergence, the larger cannabis markets have created a Mutual Recognition Agreement (MRA); for example, the Australian Therapeutic Goods Administration can export medicinal cannabis to the EU without having separate EU-GMP certification, as per MGC Pharma. But while it is a standard for everyone to aspire to, it represents a problem for smaller manufacturers, in that EU-GMP applications can be costly, with its demands for inspections, site visits, and interviews. There are also criteria for packaging, and some ambiguities remain in the certification, insofar as gaps between the Good Agricultural and Collection Practice (GACP) and EU-GMP regarding certain steps, such as drying in the production process.
The ongoing lack of clarity about what constitutes legitimacy for a medical cannabis company has so far hinged, in Europe at least, on its meeting GMP or pharmaceutical grade certification for all its moving pieces. Such ambiguities are bound to be ironed out as the industry matures and markets harmonise, but as the industry matures, it seems likely that EU-GMP will become an international standard recognised by consumers as well as regulators.