Quo vadis cannabis?

10/30/2019 | Dr. Stefan Stromeier

Dr. Stefan Stromeier
Senior Consultant · Qualified Person

By now, many companies in Germany have applied to their local regulatory authorities, depending on where they have their registered office, for an import permit or wholesale distribution authorisation. Some are currently preparing to file the application or are considering moving into this area. While preparing their applications, these companies will face a disparate range of requirements from the competent authorities in their respective federal states. Following intense preparation, official reviews and initial inspections of the companies’ QM systems and supply chain, many of these import permits and wholesale distribution authorisations will be granted without any major issues. In some cases, however, there may be some unwelcome surprises…

Changing the legal classification following inspection

Individual federal state authorities are deviating considerably from the prevailing view that medical cannabis’s classification is a medicinal product. This is also the opinion of the AATB (working group on medicinal products, pharmacies, transfusions and anaesthetics), which is striving for a unified approach across different federal states.

It is all the more important for companies to coordinate with their competent authority at an early stage, and it is advisable to do so before the application is submitted.

However, it appears that some authorities are changing their opinion on the legal classification of medical cannabis even after the inspection has taken place and the inspection report has been finalised (!). They are making a mockery of the inspection process, and applicants have to submit an entirely new application with different conditions – to the extent that the authorities’ requirements can be met by the applicants at all.

Medicinal product or pharmaceutical raw material?

One federal state in southern Germany recently classified medical cannabis as a pharmaceutical raw material. Substances in that class, such as acetylsalicylic acid or camomile blossoms, can be procured from API traders and sold on. Wholesale distribution authorisations and/or import permits are no longer necessary in this case, and applications for such permits are not accepted.

Classifying medical cannabis as a pharmaceutical raw material raises a whole host of fresh questions. For instance, would selling it on to wholesalers in other federal states in which medical cannabis is classified as a medicinal product be possible at all from the perspective of the buyer and the its local regulatory authority (procurement from a trader who does not have the required permit)?

The range of official classifications of medical cannabis as a pharmaceutical raw material, medicinal product or finished medicinal product and the accompanying consequences in the form of further obligations (or exemptions from same) are leading to strange effects.

Help from specialists

It is hard to avoid the impression that some federal states are not particularly receptive to the use of cannabis as a medicine, or that they even would like to obstruct it.

Unfortunately, no one can predict where this will go in the future. Unified federal regulations would certainly be helpful in this regard. But there are currently no signs of this – quite the contrary.
And so the situation remains suspenseful.

Take advantage of Diapharm’s (www.diapharm.com) knowledge and avoid wasting time and money during the application process… Contact us!



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