Our experienced pharmaceutical experts support companies that import flowers and oils and who, in the near future, are authorised to grow medicinal cannabis within Germany. The testing of medicinal cannabis flowers, oils or other pharmaceutical dosage forms using validated methods in a GMP laboratory is one of the prerequisites for obtaining approval and therefore access to the European market. WESSLING has the necessary narcotic license, according to §3 BtMG of the Federal Opium Agency in Germany, to carry out this analysis in its independent GMP-certified laboratory in Münster.
For several years now we have been advising international customers on the import of medicinal cannabis, both as flowers and as extracts, into the EU and Germany. We have extensive experience in conducting the necessary audits on plantations and in production and offer GAP analyses to determine GMP compliance status. Our customers also receive support from our pharmaceutical experts in setting up the necessary GMP quality management systems.
In addition to our consulting services, we conduct cannabis quality controls by testing cannabis products for identity, content and purity. This includes testing for contamination by heavy metals or pesticides, and for the content of cannabinoids, such as tetrahydrocannabinol, cannabidiol and cannabinol.
Cannabis as medicine in Germany
Medicinal cannabis has been available, with increasing demand, on prescription in Germany since March 2017. So far, cannabis pharmaceuticals have been imported from abroad, mostly from Canada and the Netherlands. In 2020, pharmaceutical cannabis grown in Germany is expected to be available for the first time. Companies can apply to the Federal Institute for Drugs and Medical Devices (BfArM) for licences to grow, distribute, store, package and deliver the plants in a secure in-house plantation within Germany. The government will shortly announce which companies will be awarded the contract. The cultivation in Germany will from now on be controlled and monitored by the Cannabis Agency.
However, the quantity tendered in the procedure is not sufficient to meet the needs for medicinal cannabis within Germany. Therefore, cannabis drugs must continue to be imported from abroad.