Mera Cannabis Corp. — EU GMP NCR (EudraGMDP) Findings

The inspection was conducted between 24th and 30th of July 2025. During the inspection ten major findings were observed, whereas one major finding was related to an external warehouse, which was not finalized yet and has no impact on the current production, and one was related to the process validation of planned products. The other major findings were related to the purchase of dried cannabis flowers from non-GMP facilities, to a missing calibrated and validated monitoring system for environmental conditions, to stability studies, to a non-functional management system for documents, samples, equipment and products, to data integrity and to qualification of facilities. Partially, it was conducted that not all corrective actions of observations from the initial inspection were taken although these were confirmed by the company. Therefore, a follow-up inspection is necessary. Action taken/proposed by the NCA: Recall of batches already released Since the certificate was issued, several batches have been imported into the EU. The decision on a recall is at the discretion of the respective competent authorities. The competent authority of Berlin decided to recall the only batch from the market that was imported so far from the Berlin importer. Since only one pharmacy was affected, no Rapid Alert Notification was issued. Prohibition of supply No further batches should be imported and supplied to the market until GMP compliance was confirmed through an inspection.