Country packs
How licences and permits work
Cannabis is controlled under the UN Single Convention on Narcotic Drugs of 1961. National authorities license each operator and authorise each international shipment: the exporting country issues an export authorisation that refers to the importing country's import authorisation. Quantities are tracked against national estimates, and every operator keeps a stock book the authority can inspect.
For an ERP this means three hard rules: no order without valid licences on both sides; no shipment beyond the balance of its authorisation; and a stock book that reconciles to the item ledger for any period. 365Phyta enforces all three.
What a country pack is
The core modules hold the rules that apply everywhere: licences, permits, the stock book and GDP distribution. What differs by market sits in a country pack, a separate extension installed per market: the authority's permit workflow and report formats, labels and product identifiers, and national pricing rules. The Germany pack includes, for example, the PZN (Pharmazentralnummer) and German pharmacy pricing rules. A country pack costs €500–1,500 per legal entity per month.
Germany: MedCanG and BfArM
Status in 365Phyta: In development
- Law: since 1 April 2024 medical cannabis is regulated by the Medical Cannabis Act (Medizinal-Cannabisgesetz, MedCanG) instead of the Narcotics Act (BtMG).
- Authority: the Federal Institute for Drugs and Medical Devices (BfArM) applies the MedCanG.
- Operator permit: cultivating, manufacturing, trading, importing, exporting or otherwise placing medical cannabis on the market requires a permit from BfArM under section 4 MedCanG.
- Per-shipment authorisation: each import or export also needs an import or export authorisation from BfArM under section 12 MedCanG, in addition to the section 4 permit. Section 14 MedCanG applies the procedure of the Narcotics Foreign Trade Ordinance (BtMAHV) of 16 December 1981.
- Volumes: Germany imported 201.1 t of medical cannabis in 2025, up from 72.85 t in 2024; Canada supplied about 93 t and Portugal about 55 t (BfArM data via StratCann).
What the Germany pack covers
The pack, in development, is designed to keep the BfArM permit in the licence register, link every inbound shipment to its import authorisation, block receipt beyond the authorised quantity, and produce the stock book and authority reports in the required format. It will also carry the PZN for each pack and the German pharmacy pricing rules. Imported lots then move through QP release and GDP distribution to pharmacies. The guide Importing medical cannabis into Germany under the MedCanG covers both BfArM approvals step by step.
Portugal: Decreto-Lei 8/2019 and INFARMED
Status in 365Phyta: In development
- Law: Decreto-Lei n.º 8/2019 of 15 January 2019 sets the framework for medicines, preparations and substances based on the cannabis plant for medicinal purposes.
- Authority: INFARMED authorises cultivation, manufacturing, wholesale trade, import and export, exclusively for medicinal, veterinary and scientific purposes.
- Renewal: authorisations are valid for no more than one year, and holders must request renewal annually or the authorisation lapses. Applications go through INFARMED's Licenciamento+ portal.
- Exports: Portugal is one of Germany's largest suppliers, with about 55 t in 2025.
What the Portugal pack covers
The pack, in development, is designed to keep each INFARMED authorisation in the licence register with its scope and expiry date, and to match every export authorisation to the destination country's import authorisation before a shipment can be released.
More country packs planned
Country packs for Germany and Portugal are in development. More country packs are planned; a new market is added as its own extension, without changes to the core modules.
FAQ
What permits does a medical cannabis importer need in Germany?
Since 1 April 2024 medical cannabis is regulated by the Medical Cannabis Act (MedCanG) instead of the Narcotics Act (BtMG). An importer needs a permit from BfArM under section 4 MedCanG and, for every shipment, an import authorisation from BfArM under section 12 MedCanG. The exporting country must issue a matching export authorisation.
Who licenses medical cannabis activities in Portugal?
INFARMED authorises cultivation, manufacturing, wholesale, import and export of cannabis-based medicines, preparations and substances under Decreto-Lei 8/2019. Authorisations last no more than one year and must be renewed annually.
Which markets does 365Phyta support?
Country packs for Germany and Portugal are in development, each with its permit workflow, authority formats, labels and national pricing rules, such as the PZN and German pharmacy pricing in the Germany pack. More country packs planned. The core modules (licences, permits, stock book, GMP and GDP) are not country-specific.
Sources
- BfArM, Bundesopiumstelle: Medizinisches Cannabis, including Erlaubnis and Einfuhr und Ausfuhr.
- Medizinal-Cannabisgesetz (MedCanG): § 4 Erlaubnispflicht, § 12 Genehmigung zur Einfuhr und Ausfuhr and § 14 Geltung der Betäubungsmittel-Außenhandelsverordnung (gesetze-im-internet.de).
- Diário da República, Decreto-Lei n.º 8/2019.
- INFARMED, Canábis para fins medicinais.
- StratCann, "Canada continued to supply bulk of German medical cannabis imports in 2025" (BfArM data).
- UNODC, Single Convention on Narcotic Drugs, 1961.
See the permit checks in a demo
See a shipment go from Portuguese export authorisation to German import authorisation, QP release and pharmacy delivery.