One of the major Canadian companies hoping to set up shop in Malta has 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.
However, Zenabis has said that they had announced back in August that they would be shifting their focus for GMP certification from their “smaller facility at Zenabis Delta, to our larger facility at Zenabis Altholville. Since there is no way to withdraw a GMP application, it will appear as though we abandoned our plans to become GMP certified, but that is not the case. Therefore, we do not anticipate an impact in our ability to export to Europe.”
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.
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.