With the legalisation of cultivation and export of medicinal cannabis products within Australia, many growers and companies producing medicinal cannabis products have set their interest in exporting their excess products to other parts of the world.
A market of particular interest is Germany in which 60,000 patients registered for use of medicinal cannabis products in 2019, with this number is expected to triple by the end of 2020. This rise in demand is turning Germany into one of the largest market in Europe for medicinal cannabis products and it has become the centre of attention for exporters, not just from the neighboring European countries such as North Macedonia, UK, Greece and Portugal, but also those further afield such as Israel, Columbia and even here at home in Australia.
What are the Australian licensing requirements for exporting medicinal cannabis products?
In layman’s terms, if an Australian company intends to export medicinal cannabis products, it must first ensure that the products are produced in accordance with appropriate licenses and permits (PharmOut can help you with this). This may include:
- Medicinal cannabis licence and permit issued by ODC (for growers and producers) and/or
- ODC manufacture licence and GMP Manufacturing licence issued by Therapeutic Goods Administration (TGA) (for cultivators who also intend to manufacture finished product and manufacturers who intend to buy bulk for formulating, filling, packing and labelling)
- State or territory licence and permit as appropriate, and
- Licence and permit for export, issued by the ODC.
What are the testing requirements?
All products intended for export must be manufactured in accordance with the GMP and be compliant with the TGO 93 Standard for Medicinal Cannabis. In addition, the products manufactured for export to Germany must demonstrate compliance with:
- Good Agricultural and Collection Practice, GACP – the guidelines of good practice for the collection and cultivation of medicinal plants
- EudraLex 4 – Volume 4 – Good Manufacturing Practice (GMP) guidelines and
- EU guidelines on Good Distribution Practice (GDP) of medicinal products for human use (2013/C 343/01).
The imported products should be tested to demonstrate that they comply with the German Pharmacopoeia (Deutsches Arzneibuch, 2019, DAB 2019) for standardised cannabis extract or cannabis flower. Note that the products may need to be re-tested in Germany prior to review and their release for supply by a Qualified Person (QP).
What are other requirements?
To be eligible for export, the products must be either registered or listed as ‘export-only’ on the Australian Register of Therapeutic Goods (ARTG).
A product is registered on the ARTG following rigorous review of its safety, quality and efficacy, and approval for use in Australia by the TGA.
At this stage, most if not all medicinal cannabis products intended for export are listed for ‘export-only’ on the ARTG. These products are manufactured under a current TGA GMP licence, however they have not been reviewed or approved by TGA for commercial supply in Australia.
At present, types of medicinal cannabis products allowed to be imported by the ODC include:
- cannabis extract for further manufacturing or
- final medicinal cannabis products such as cannabis oil, capsules, therapeutics creams, edibles etc.
Note that dry flower manufactured in compliance with the GMP under Annex 7 of the PIC/S Guide to GMP code, as a herbal medicine would be approved for export.
As the main market interest in Germany appears to be dry flower, this may add additional cost and complexity to our growers and producers who will have to comply with GMP requirements for manufacture further upstream in the production of the medical cannabis products.
What are the requirements for importing medicinal cannabis to Germany?
The Federal Opium Agency is responsible for the application process for the imports in Germany which is crucial for trading medicinal cannabis.
The Australian exporter must ensure that their prospective importer in Germany has appropriate authorisation to import medicinal cannabis material including:
- manufacturing authorisation (if importing material for further manufacture)
- wholesale licence for storage and distribution (if importing finished products)
- an import permit
- a permit for testing according to Medicinal Products Act (BGBI)
- a permit as per the Narcotic Drugs Action (BtMG)
These authorisations must be overseen by an officer of demonstrable expertise
The Australian exporter must also demonstrate compliance with EU GMP microbiological limits or else comply with stringent irradiation requirements which requires a special permit to distribute these irradiated products and demands a separate application to the Federal Institute for Drugs and Medical Devices (BfArM) for each variety of flower to be distributed.
In addition, the exporter must ensure that the required security measures (which include secure storage, safe rooms and surveillance systems) are met during the storage and transport of the medicinal cannabis material to Germany, to prevent any diversion during transport that might result in theft or loss of the exported products.
If you have any questions or you are unsure on where GMP should be applied in your manufacturing process, contact us. We can help.