Importing medical cannabis into Germany under the MedCanG

The legal basis

Since 1 April 2024, medical cannabis in Germany is regulated by the Medical Cannabis Act (Medizinal-Cannabisgesetz, MedCanG) rather than the Narcotics Act (BtMG). The MedCanG covers cultivation, manufacture, trade, import, export and other handling of cannabis for medical or medical-scientific purposes. It is administered by the Bundesopiumstelle, the Federal Opium Agency inside the Federal Institute for Drugs and Medical Devices (BfArM). Two separate approvals sit inside this framework, and an importer needs both: the operator permit and the per-shipment authorisation.

The section 4 permit

Section 4 MedCanG requires a permit from BfArM for anyone who wants to cultivate, manufacture, trade in, import, export, supply, sell, otherwise place on the market, procure or acquire cannabis for medical purposes. BfArM grants the permit to the company for a named site and for the scope of activity it needs, and it is a precondition for every per-shipment authorisation described below.

The application goes to BfArM under section 7 MedCanG. It names the applicant and each responsible person, with a criminal record certificate and proof of expertise for each of them, describes the sites and buildings, and states which activities and which type of cannabis the permit should cover. BfArM publishes separate forms and notes for cultivators, traders and manufacturers, charges a fee under the Federal Health Ministry's special fees ordinance (BMGBGebV), and, under section 8, must be told without delay of any later change to the information in the application.

A permit is activity-specific. A company that only imports and distributes needs the permit to cover importing and trading; a company that also processes or repackages needs it to cover manufacturing as well. Checking which activities are actually licensed, and keeping that scope current as the business changes, is worth doing before it becomes a finding during an authority visit.

The per-shipment import authorisation

Holding a section 4 permit does not by itself authorise any particular import. Section 12 MedCanG requires a further authorisation from BfArM for each import or export, in addition to the permit. Section 14 MedCanG applies the Narcotics Foreign Trade Ordinance (Betäubungsmittel-Außenhandelsverordnung, BtMAHV) of 16 December 1981 to how these authorisations are granted, and to import, export and transit of medical cannabis generally. BfArM publishes the import application form (Einfuhrantrag) with notes on filling it in, and also offers electronic applications through its NDS web portal.

Transit through Germany is addressed separately in section 13 MedCanG: it is allowed only under customs supervision, without any stay beyond what transport or handling requires, and without the consignment being made available to anyone or treated in a way that changes its condition, labelling or packaging.

The import authorisation on the German side must be matched by an export authorisation issued by the competent authority of the sending country for the same consignment, under the 1961 Single Convention system that both countries operate within. Neither side can ship or receive without the other's paperwork in place, which is why lead time on the export side (for example INFARMED in Portugal) directly affects when a shipment can move.

Cannabis from outside the EU and the EEA

The Medicines Act (Arzneimittelgesetz, AMG) adds two requirements for supply from third countries. Section 72 AMG requires an import licence (Einfuhrerlaubnis) from the competent authority for anyone who commercially imports medicinal products, or active substances of human, animal or microbial origin, from a country that is neither an EU member state nor a party to the EEA agreement. Section 72a AMG then allows medicinal products and active substances to be imported from such countries only where a certificate from the competent authority of the country of manufacture confirms GMP standards equivalent to the EU's, or where a German authority has certified GMP compliance, or where the competent authority certifies that the import is in the public interest. Whether a consignment falls under these sections depends on how it is classified under the AMG, so confirm the classification with the competent authority. Neither section applies to supply from within the EU or the EEA; the MedCanG permit and the section 12 authorisation apply in both cases.

The GMP rules follow the material. EU-GMP Annex 7 expects the manufacturer of a herbal medicinal product to make sure that its suppliers of the herbal substance comply with Good Agricultural and Collection Practice (GACP). Where the imported batch is a finished medicinal product, EU-GMP Annex 16 (section 1.5.4) makes the certifying Qualified Person responsible for ensuring it has undergone full testing in a member state, unless a mutual recognition agreement with the exporting country applies.

Records and reports after receipt

Section 16 MedCanG obliges every permit holder to keep continuous records, separately for each site and each type of cannabis: the date, the quantities received and dispensed, the resulting stock and, for imports and exports, the name and address of the foreign exporter or importer. The records must be kept for three years. Each year, by 31 January, the permit holder reports the previous calendar year to BfArM, including the stock at year end, in the electronic format BfArM specifies.

Before you ship: a working checklist

1. Confirm the section 4 permit covers the activity and the site.Importing must be within the scope BfArM has approved for the company, at the site that will receive the goods.
2. Apply for the section 12 authorisation for the specific shipment.Quantity, product and counterparty need to match what is requested and what is later received.
3. Confirm the sending country's matching export authorisation exists.An import authorisation with no corresponding export authorisation cannot be used.
4. For supply from outside the EU and the EEA, confirm the section 72 AMG import licence and the section 72a certificate.GACP for the cultivation and GMP for the manufacture need to be documented, not just asserted.
5. Check the authorised quantity balance before booking the shipment.A shipment above the remaining authorised amount cannot be received.
6. Record the receipt under section 16 MedCanG.The records must reconcile to the authorisation and to physical stock for any period the authority asks about, and feed the annual report due by 31 January.

Where 365Phyta fits

365Phyta keeps the section 4 permit and each section 12 import authorisation in the licence register, links every inbound shipment to its authorisation, and blocks receipt above the authorised quantity, as part of the Germany country adapter. The adapter also produces the stock book and authority reports in the required format. Imported lots then move through EU-GMP batch records and QP release to GDP distribution to pharmacies. Importers who release batches from third countries can add Phyta GMP for their QA and QP users. See 365Phyta for importers and wholesalers or Importer pricing.

FAQ

Sources

1. BfArM, Bundesopiumstelle: Medizinisches Cannabis, including Erlaubnis and Einfuhr und Ausfuhr.
2. Medizinal-Cannabisgesetz (gesetze-im-internet.de): § 4 Erlaubnispflicht, § 7 Antrag, § 8 Änderung von Angaben im Antrag, § 12 Genehmigung zur Einfuhr und Ausfuhr, § 13 Durchfuhr, § 14 Geltung der Betäubungsmittel-Außenhandelsverordnung, § 16 Aufzeichnungen und Meldungen.
3. Arzneimittelgesetz (gesetze-im-internet.de): § 72 Einfuhrerlaubnis and § 72a Zertifikate.
4. European Commission, EudraLex Volume 4: Annex 7 (manufacture of herbal medicinal products) and Annex 16 (certification by a Qualified Person and batch release).
5. UNODC, Single Convention on Narcotic Drugs, 1961.

Last reviewed: September 2026. General information, not legal advice. Terms used on this page are defined in the glossary.