European Union Good Manufacturing Practice (EU-GMP) certification audits involving cannabis facilities in Canada and elsewhere are screeching to a halt given the travel restrictions in place in most of the world because of the coronavirus pandemic.
The discontinuation of the audits has meant that some overseas medical cannabis producers can’t receive the key certification to begin exports to the EU market.
In particular, German GMP inspectors aren’t traveling to Canada, Colombia, Lesotho and other export nations outside the EU to certify medical cannabis production facilities.
As a result, the companies whose facilities weren’t audited before the pandemic now face a challenging situation:
- The chances of getting EU inspectors to travel overseas are slim.
- Audits are necessary to receive the EU-GMP certificate, which typically is required to begin exports to EU markets.
This means, for now, that the handful of EU-GMP certified companies supplying Germany with medical cannabis from Canada and from inside the EU are likely to continue enjoying an effective oligopoly.
That might not last long, however, as domestic producers in EU countries such as Denmark or Portugal become certified by their respective domestic health agencies.
That would allow medical cannabis companies in those countries to ship throughout the European Union, which would start to displace and eventually replace more expensive Canadian imports.
Because of the COVID-19 pandemic, German authorities are currently not certifying new producers overseas, in line with measures taken by health authorities in other countries.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom is also scaling back inspections for pending applicants.
“As part of our response to the coronavirus outbreak, we have decided to conduct only essential on-site Good Practice (GxP) inspections … until further notice,” the MHRA recently announced.
Other national health authorities, including the U.S. Food and Drug Administration, also have postponed foreign inspections amid the pandemic.
In Germany’s comparatively decentralized health system, midlevel regional government authorities or municipal governments are the ones responsible for performing GMP audits and issuing certifications.
Marijuana Business Daily contacted some of the German authorities who previously have certified Canadian cannabis producers facilities, and the conclusion from the answers obtained is that new EU-GMP inspections in Canada or other non-EU countries are almost impossible to conduct now.
And once the COVID-19 crisis subsides, health authorities will probably have a backlog of more urgent issues, so further delays in EU-GMP inspections could occur.
Another option could be a producer in a non-EU country that has a GMP Mutual Recognition Agreement with the EU getting certified by its domestic authority.
But, so far, all products being sold to German patients originate from other EU countries or Canadian facilities that previously received GMP certification from European health authorities.
Most of those EU-GMP certificates of Canadian facilities were issued by German authorities, although Malta and the Czech Republic have also provided certification.
Below is the current status of some of the jurisdictions that have been responsible for inspecting international cannabis producers.
- Upper Bavaria
Verena Gros, a spokeswoman for the regional government of Upper Bavaria – the most populous Bavarian administrative district centered in Munich – told MJBizDaily that “currently, no GMP inspections are being carried out in third countries. Previously scheduled inspections have been or will be postponed to the second half of 2020.”
The Upper Bavarian government was responsible for the recent certifications of Eve & Co (Natural MedCo) and Northern Green Canada.
Upper Bavaria issued the certificates in March 2020, but the inspections were carried out in November 2019.
Dirk Abel, spokesman for the Tübingen administrative government, said travel restrictions and emergency staffing measures in place because of the coronavirus will impact GMP inspections.
“Domestic inspections are carried out restrictively and according to strict prioritization,” he said.
Regarding inspections abroad, Abel said “even stricter criteria applies” because “cannabis is not considered a life-saving drug, and foreign inspections will not be given high priority until the (COVID-19) situation has eased.”
“Remote audits can be an emergency solution in specific individual cases, but here, too, other medicines will be given higher priority until further notice,” Abel said.
The Tübingen government has certified two Canopy Growth facilities in Ontario: Tweed in Smiths Falls and Tweed Farms in Niagara-on-the-Lake.
The latest inspections to renew the certificates were carried out at the end of January 2020, with the certificates reissued in mid-March.
Silvia Kostner, spokeswoman for Berlin’s Office of Health and Social Affairs, confirmed that no inspections in foreign countries are currently being carried out.
Because of the “dynamic global corona situation, no statement can be made about the time horizon,” she said.
The Berlin Office of Health and Social Affairs was the authority that issued GMP certificates for Aurora Cannabis facilities in Cremona, Alberta, and in Bradford, Ontario.
Dirk Schneemann, spokesman of the governmental district of Cologne, told MJBizDaily that GMP inspections in third-party countries cannot be carried out currently due to worldwide travel restrictions.
“If the situation does not change in the longer term, case-by-case considerations may be necessary in order to decide whether to conduct remote audits (desktop assessments) instead of on-site inspections.”
Aurora’s MedReleaf facility in Markham, Ontario, received a GMP certification from the Cologne authority in 2018.
Mandy Peschang, spokeswoman of the Landesdirektion Sachsen, said “business trips are to be limited to the absolutely necessary extent.”
She said decisions about inspections are made on a case-by-case basis, which includes assessing risk.
The regional German government granted EU-GMP certification to Wayland Group’s facility in Langton, Ontario, in 2018.
Alfredo Pascual can be reached at email@example.com
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