Here’s what  LovinMalta are reporting about Zenabis & their aim to set up in Malta as a way of accessing the EU market.

 

One of the major Canadian companies hoping to set up shop in Malta has run into an obstacle after it failed a GMP (good manufacturing practice) inspection on their Delta, British Colombia facility.

A “statement of non-compliance” was published by Maltese regulators last December, where Zenabis was found to not have complied with the European Union’s GMP requirements.

Zenabis was found to have failed to have achieved a “correctly implemented pharmaceutical quality system” – a critical deficiency – as well as another 29 other red flags, nine of them being considered “major”.

Following the failed inspection, the company had sent in a “corrective and preventive action” plan to sort out the issues raised in the failed inspection – but Zenabis never followed through on their own plans.

“The company failed to follow-up on this plan and to meet the commitments made. The company changed its plans and no longer actively rectified the deficiencies to come in line with EU-GMP according to the mutually agreed reasonable time-frame,” a report published on EudraGMDP, the online database run by the European Medicines Agency, said.

Maltese regulators have now said that the sale, import and distribution of any medical cannabis product produced at Zenabis’ Delta facility was banned in Malta and was not allowed to be imported. This is going to make the company’s plans to use Malta as a stepping stone into the EU much harder.

Zenabis had previously announced that it had signed a non-binding Letter Of Intent with a Maltese brand that featured a chain of 15 Maltese pharmacies. However, this agreement depending on Zenabis reaching GMP standards.

Bloomberg reported that Zenabis had also signed a non-binding LOI with a European distributor to provide 6,000 kilograms of dried cannabis flower yearly from 2020.

But following their failed inspection, Zenabis seems set to face an uphill battle in the European field.

Indeed, Zenabis reportedly didn’t disclose the failed inspection to investors. The company’s stock has reportedly fallen by 2.5 per cent since the failed inspection, and have dropped an entire 97 per cent since reaching a high of $6.10 in January.

Source:  https://lovinmalta.com/news/canadian-medical-cannabis-company-fails-maltese-standards-inspection/

Also see the Bloomberg report  https://www.bnnbloomberg.ca/zenabis-facility-failed-inspection-for-eu-quality-certification-last-year-1.1358101