Separate the medical route from other cannabis activities
The medical route has its own legal framework. Under § 3 MedCanG, prescription and dispensing to end users follow medical and pharmacy rules. Arrangements used for non-medical cannabis activities should not be treated as authorisation for a pharmaceutical supply chain.
Begin with a written description of the material and intended use. A flower, extract, active substance and finished medicinal product should not automatically be assigned the same pharmaceutical route. Clarify classification before promising a supply model to a customer.
Check the MedCanG permission for the proposed role
§ 4 MedCanG establishes a BfArM permission requirement for activities including cultivation, manufacture, trade, import and export of medical cannabis. The role-specific exceptions in § 5 MedCanG also need to be considered; an exception applying to one participant does not automatically cover a commercial partner.
Check the permitted activities, premises and product scope. Keep a controlled record of the documents used for the assessment and identify who will confirm changes with the relevant authority.
Assess pharmaceutical authorisations separately
Medicinal-product wholesale is addressed by § 52a AMG; manufacturing and certain third-country import activities are addressed by § 13 AMG and § 72 AMG. Their scope and exceptions matter. In particular, do not assume that the import rules for a finished medicine apply identically to every botanical active substance.
A useful internal matrix lists each legal entity, operating site, product type, activity and authorisation. Ask the competent authority to resolve a classification or scope question before treating a general certificate as sufficient.
Distinguish the standing permission from shipment approval
For medical cannabis, § 12 MedCanG requires approval for the individual import or export in addition to the § 4 permission. BfArM’s NDS web information describes the electronic submission of applications and notifications.
Plan the shipment around the required approvals, document consistency and the counterpart’s export arrangements. A signed purchase order or a general business permission is not itself an individual shipment approval.
Maintain quality evidence and operating records
The European Commission publishes the applicable GMP guidance in EudraLex Volume 4. Check which requirements fit the material and operation, including any outsourced activity. Supplier qualification, specifications and batch results should be evaluated as parts of the wider quality assessment.
§ 16 MedCanG requires ongoing records by site and cannabis type and specifies reporting duties for permission holders. Its records must be kept for three years. Other pharmaceutical, tax or contractual obligations may require separate records or longer periods.
Monitor changes without treating proposals as current law
The Health Ministry has published information about a proposed MedCanG amendment, including prescribing and supply-channel changes. A proposal page is not, by itself, proof that a restriction has entered into force. Check the enacted wording and commencement provisions before changing a business process.
Assign an owner for regulatory monitoring and document the date of each review. This article is an orientation for professional discussions; the requirements for a specific product, site or transaction need to be established with the competent authorities and appropriate advisers.
Before you take the next step
Classify the product and intended use.
Map MedCanG permissions and any relevant exceptions.
Review pharmaceutical authorisation requirements.
Confirm individual import or export approvals.
Allocate responsibility for records and regulatory updates.
Sources and further reading
Sources checked: 27 October 2026.
MedCanG § 3 — prescribing and dispensing
MedCanG § 4 — permission requirement
AMG § 52a — pharmaceutical wholesale
AMG § 13 — manufacturing authorisation
AMG § 72 — import authorisation
MedCanG § 12 — import and export approval
MedCanG § 16 — records and reporting
European Commission — EudraLex Volume 4
