EU-GMP: TerrAscend achieves milestone; first in a ‘new wave’ for exporters?

Canadian cannabis license holder TerrAscend has received EU-Good Manufacturing Practice (GMP) certification, a requirement for any business looking to sell its medical marijuana products in the European Union.

This milestone ends a period of more than one year without any new Canadian cannabis company receiving such certification.

The company expects to make its first shipment to Germany “this quarter,” CEO Michael Nashat told Marijuana Business Daily.

“We’ve received requests from multiple distributors in other European jurisdictions to supply them as well,” he added, “but our priority is to first consistently supply the German market and then move into others.”

A new ‘wave of certifications’

The achievement “might actually be the start of a second wave of certifications,” according to Karina Lahnakoski, vice president of quality and regulatory at Vancouver, British Columbia-based Cannabis Compliance, a company that assisted TerrAscend in becoming certified.

EU-GMP certification became a big topic in 2018 “as Canadian companies actively started to see Europe as the next big market,” she said.

Aurora Cannabis and Canopy Growth each attained certification for two facilities; Cronos Group, Tilray and Wayland have one certified facility apiece.

“Many companies started to pursue the certification in 2018, and it takes about a year or more of serious work to get to EU-GMP from GPP (Good Production Practices) – the Canadian quality certification,” Lahnakoski said.

“It’s not just a few tweaks here and there; rather, (it’s) a systems overhaul.”

Starting on the right foot is crucial, Nashat said.

“Companies first need to understand what needs to be done to become an EU-GMP certified cannabis producer, and that alone can take a lot of time and effort,” he said.

“One advantage we had was that we built our facilities and processes from the beginning with the goal of becoming GMP-certified down the road. The first step is to build it right, right from the start. But that’s just the first step.”

The average Canadian cannabis cultivator or manufacturers probably hasn’t thought out EU-GMP, Lahnakoski said, so their facilities likely aren’t even prepared for that first step.

“Validations of facilities, equipment and procedures and especially generating stability data – something not necessary for GPP – takes many months,” she said.

That stability data will show if the products that the companies want to export have “more than enough shelf life.”

Companies also should consider a pre-audit to mitigate rises.

“If not truly ready, companies will waste money, time and – even worse – generate reputational damage with the importer and the European health authorities,” Lahnakoski said.

“Fortunately, we didn’t have any critical observations,” Nashat added. “We had the inspection in December 2018 and after addressing a few non-critical observations, we got certified at the end of April 2019.”

And the costs don’t stop with the initial investment to be granted certification.

“A GMP facility generally has higher operational costs than one that isn’t,” Nashat said.

“But we believe it’s worth it when your mission is to provide products with the best quality and safety to patients, both domestically and abroad.”

Learning about GMP

Resources are available for companies looking to gain EU-GMP certification, regardless of where they are on the readiness scale.

The ECA Foundation, a European association focused on pharmaceutical quality assurance and GMP-GDP compliance, will host its first-ever session on GMP for cannabis before the organization’s biennial GMP conference in June.

That first event quickly sold out, leading the organization to announce another event at the end of October, Dr. Andrea Kühn-Hebecker, operations director for the event, told MJBizDaily.

“There is a need for all sides – producers, pharmacists and physicians – to become familiar with the relevant regulatory and GMP-GDP requirements and aspects of medical cannabis,” Kühn-Hebecker said.

Alfredo Pascual can be reached at [email protected]

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