02/12/2019: Med. cannabis/CBD: Legal conditions!

The demand for the import of medical cannabis into Germany (cannabis is prohibited for leisure use
in Germany) remains very high, as the Berlin-based law firm Dr. Späth & Partner Rechtsanwaelte
points out:

Already in 1 to 2 years there could be already approx. 100,000 to 200,000 patients in Germany, in the
long run several 100,000 patients, straight with diseases such as pain or Epilepsie could bring med.
Cannabis – only this is certified in Germany – relief.

According to media reports, not only has the WHO recently made recommendations for the
reclassification of cannabis and CBD, namely to delete them from ” Schedule IV of the Uniform
Convention on Narcotic Drugs (1961)”, but also according to media reports (see e.g. aerzteblatt.de of 29.01.2019) Israel had also approved the export of medical cannabis and according to media reports the Ministry of Health had announced that within 6-9 months the manufacturers also received the approval for export to Germany.

More and more companies are therefore interested in a so-called import licence, e.g. under Article
72 of the Medicines Act, for the import of medicinal cannabis into Germany. According to Dr. Spaeth
& Partner, it is also becoming increasingly interesting for investors to work together with a
pharmaceutical importer in this area.

In addition to the time required to obtain the import licence, which experience has shown to be
between 3-12 months (in individual cases even longer), interested companies should consider that a
BtM licence usually requires not only a competent person such as a doctor or chemist, etc., but also a narcotic storage facility for safe storage.

It must always be checked on a case-by-case basis whether companies from these or other countries are suitable for cooperation, as GMP certification is usually required here.

In addition, interested companies wishing to import medical cannabis should be aware that the
effective contractual requirements must always be taken into account when importing medical
cannabis, such as effective jurisdiction agreements, letters of intent, NDO etc.

The market for cannabidiol, CBD, the non-psychoactive component of cannabis, is also growing

In some cases CBD is said to have a very good effect as a drug, e.g. for pain, in others CBD products
such as CBD oils are marketed as dietary supplements. Even a renowned drugstore chain in Germany has now added CBD oils to its shelves.

But also here caution is appropriate and always in individual cases the legal admissibility to examine, because recently had confiscated according to various media reports the police in Berlin use hemp of a Kreuzberger company, which had driven their commodity out to several „Späti-Shops“.

The company is accused of a violation of the Narcotics Law, among other things, the authority refers
to a criminal conviction of the OLG Hamm from the year 2016, which of course could have
considerable legal consequences.

It must therefore always be checked in each individual case for the respective CBD product whether a narcotic, a drug, a food or dietary supplement or cosmetic, etc., is present.

Here it has to be differentiated whether a full spectrum product, an extract or an isolate is present,
with CBD-E-Liquids regulations from the chemical law have to be considered also under

In addition, the EU Novel Food Regulation must be taken into account under certain conditions.

Interested companies wishing to operate in the growth markets of medical cannabis or CDB must
therefore comply with the legal requirements in order to be on the safe legal side.

Companies from Germany and abroad, but also investors who want to become active in the field of
medical cannabis import to Germany or CBD, are welcome to contact Dr. Späth & Partner
Rechtsanwälte mbB.

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