Remexian Wins Legal Battles Amid German Cannabis Licensing Dispute

These are turbulent times for the cannabis industry. The planned amendment to the medical cannabis law threatens to restrict its operations. Internal competition also presents new challenges. The German cannabis wholesaler Remexian is currently embroiled in a heated dispute with its competitors.

At the end of August, the international law firm Hogan Lovells sent a letter to Remexian pointing out potential regulatory violations in the approval process for the cannabis products the company distributes. The firm was commissioned by Vayamed GmbH – a competitor of Remexian. Subsequently, some competitors apparently leaked information to pharmacists suggesting that the approval status of Remexian products was in question. This prompted the company to take legal action.

Are container permits legal?

The subject of the dispute is the distribution of irradiated medical cannabis. To reduce microbiological contamination, medical cannabis can be exposed to radioactive radiation.

A letter from Hogan Lovells alleges that Remexian marketed various irradiated medical cannabis strains with identical registration numbers. These were sold under the group names “Madrecan 18/1,” “Madrecan 21/1,” and “Madrecan 24/1.” This was reported by the Canadian cannabis news portal StratCann.

Vayamed GmbH accused Remexian of violating Section 7 of the German Medicines Act (AMG) in conjunction with Section 1 of the Ordinance on Radioactive Medicinal Products (AMRadV). Container approvals for multiple irradiated cannabis strains are not permitted under German law. Vayamed also accused Remexian of unfair competition.

In response to an inquiry from DAZ regarding the possibility of container approvals for irradiated cannabis flowers, the BfArM stated: “As a general rule, a separate application for approval is required for each cultivar. Existing approvals remain valid, however, under the aforementioned conditions and in accordance with the interpretation that has been in place since the introduction of the procedure (one application per cultivar).”

Competitors are worried about their reputation

Finn Hänsel, CEO of the Sanity Group, which is also active in the cannabis wholesale trade, told StratCann that German cannabis suppliers are concerned that potential regulatory violations by individual competitors could cast the entire industry in a negative light.

He emphasized the importance of ensuring that the same quality standards apply to all companies. Hogan Lovells has requested that Remexian issue a cease-and-desist declaration. Otherwise, they reserve the right to take further legal action, including filing a criminal complaint.

Legal action against allegations

The cannabis wholesaler Cansativa sent a letter to its customers informing them, in light of the allegations, that no Remexian products would be in stock for the time being. Remexian was able to obtain a cease-and-desist order, dated September 12th, against this. According to this order, Cansativa has committed to refraining from claiming that Remexian is distributing cannabis flowers from different cultivars under the same registration number, when separate registration numbers are required for each.

Remexian achieved another victory against its competitor Four 20 Pharma. An injunction was obtained from the Hamburg Regional Court on September 18th. According to this injunction, Four 20 Pharma is prohibited from claiming to third parties – “especially pharmacists” – that a separate marketing authorization number is required for each combination of cultivar/variety and active ingredient content.

Such a licensing requirement exists only for irradiated cannabis flowers as defined in Section 7 of the German Medicines Act (AMG). “However, this limitation to cases of irradiation licensing is not sufficiently clear from the challenged statement.” It gives the impression that a licensing requirement applies to all varieties and combinations of active ingredients.

Furthermore, Remexian was able to credibly demonstrate that it possesses a valid marketing authorization for at least the product Madrecan 21/1 – one of the three products in dispute. The BfArM (Federal Institute for Drugs and Medical Devices) has also been aware since January 2024 that the company has marketed cannabis flowers from different cultivars under the same marketing authorization number.

On October 31st, the Berlin II Regional Court also issued an injunction against competitor Demecan. This case also concerned the dissemination of the claim that Remexian was distributing cannabis in violation of applicable licensing regulations.

Irradiated or non-irradiated flowers

The original cease-and-desist letter against Remexian accused the company of distributing various cannabis strains with similar active ingredient content under generic names. Because these strains were radioactively irradiated, container approval was deemed unlawful.

In the context of the two preliminary injunctions against the competition, Remexian credibly demonstrated that it possessed a valid individual approval, at least for the product Madrecan 21/1.

On the medical cannabis portal Flowzz, most Remexian products are listed with the suffix “irradiated” (Madrecan 21/1 Punch Cake, Madrecan 24/1 HiFi 4G, Madrecan 18/1 Granddaddy OG, Madrecan 21/1 Granddaddy OG). According to the cease-and-desist letter from Hogan Lovells – acting on behalf of Vayamed – all strains are registered under group approval numbers. Another strain from these approval groups is sold as “non-irradiated” (Madrecan 24/1 Skywalker).

Remexian Pharma states that it holds valid marketing authorizations for its entire portfolio. Eighty-five percent of these are non-irradiated cannabis flowers, for which no individual authorization is required. “In accordance with the updated BfArM (Federal Institute for Drugs and Medical Devices) guidelines, the company has submitted individual marketing authorization applications for each cultivar, in addition to the existing authorizations, and is thus consistently implementing the new requirements.”

Voices from the industry further point out that, in their view, Remexian continues to distribute various irradiated cannabis strains under container registration numbers.

Dispute after Remexian’s takeover

Shortly before receiving the cease-and-desist letter, the Canadian cannabis company High Tide announced in August its acquisition of 51 percent of Remexian’s shares. The acquisition was finalized in early September.

Omar Khan, Chief Communications and Public Affairs Officer at High Tide, told StratCann he was confident that Remexian complied with all applicable regulations in Germany. He added that Remexian and High Tide took compliance with the legal framework “extremely seriously.” Raj Grover, CEO of High Tide, called the accusations unfounded, stating they were part of a coordinated campaign against High Tide and Remexian.

__

(Featured image by Richard T via Unsplash)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.

First published in Deutsche Apotheker Zeitung. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.