By / December 17, 2019

Company operates without a license to irradiate cannabis

Although intermediaries have been supplying medical cannabis to pharmacies for more than two years, the authorities only now seem to have noticed that most of these dealers lack a license from the Federal Office for Radiation Protection to irradiate cannabis.

To protect cannabis flowers from mold and bacteria, these plants are exposed to ionizing radiation. If, however, dealers want to place these medicines on the market that have been treated this way, they need a special permit.

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Dealers require license to irradiate cannabis

This problem mainly concerns the cannabis flowers of Bedrocan, the most important European importer for Germany.

The importer gives its goods to the Office for Medical Cannabis at the Ministry of Health, which then has a service provider irradiate cannabis products with gamma radiation of cobalt 60. The company also has GMP approval for this. The irradiated flowers are then exported to Germany.

The intermediaries who have import licenses for Bedrocan, however, were apparently never checked whether they also hold the necessary license from the Federal Office for Radiation Protection to market irradiated drugs.

This problem was only recently noticed when the authorities in Cologne and Düsseldorf banned a wholesaler from selling cannabis flowers without the necessary license to irradiate cannabis.

CannaMedical from Cologne, Germany, however, informed on request that the company has all necessary approvals and can continue to supply Bedrocan.

The different classifications of cannabis flowers

A further problem is that the respective federal states and supervisory authorities classify cannabis flowers differently.

They are classified either as an active substance, a drug, a finished drug or a basic substance. Depending on the category, different pharmaceutical regulations also apply.

The BfArM allegedly wants to remedy this situation in 2020. Then a “nationwide clarification of the classification of cannabis flowers” is to be implemented.

Bedrocan’s failure for a license to irradiate cannabis may cause a short supply

Bedrocan currently supplies 200 kg cannabis per month for the German market but these are now missing. In addition, the cannabis manufacturer Aurora is also struggling with delivery problems.

There is currently no medical cannabis from Aurora available in Germany. Also here it is a “step in the production process,” as Aurora announced, for which they need an additional permit.

Fresh flower and leaves prepared for employee to irradiate cannabis
It is estimated that by 2020 a unique classification for cannabis flowers will be implemented. (Source)

No cannabis products from Aurora will be sold until the authorities have issued these.

How severe will delivery failures be?

Who now supplies German cannabis patients with their medication when Bedrocan and Aurora fail? Cannabis companies such as Canopy, Tilray, and CannaMedical stated that they would continue to be able to deliver.

But whether they are able to completely compensate for delivery failures due to a lack of license to irradiate cannabis or other issues is very questionable. This could be particularly difficult for patients who are dependent on flowers.


(Featured image by Sharon McCutcheon via Unsplash)

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