Denmark (Jurisdiction Profile)

Jurisdiction Identity

Field Value
Country Denmark
ISO country code DK
National authority Lægemiddelstyrelsen (Danish Medicines Agency, DMA)
Governing act LOV nr 1668 af 26/12/2017, as amended by LOV nr 439 af 06/05/2025
Scheme status Permanent since 1 January 2026 (previously a pilot from 1 January 2018)
Official sources https://laegemiddelstyrelsen.dk/da/special/medicinsk-cannabis/ ; https://www.retsinformation.dk/eli/lta/2025/439
Last verified 2026-08-10

Cannabis Framework

Dimension Status
Adult-use possession Not permitted
Adult-use commercial supply Not permitted
Medical access Permitted; permanent scheme since 1 January 2026
Prescribing authority All licensed physicians, on clinical judgement — no fixed diagnosis list
Domestic cultivation (commercial) Permitted only under a DMA manufacturing permit with cultivation activity
Home cultivation Not permitted
Import of cannabis biomass Permitted from EU/EØS countries for further processing (widened by the 2026 framework)
Import/export of finished product Requires a certificate; cannabis is on List B of the Euphoriant Substances order (BEK nr 405 af 26/03/2026)
Reimbursement Partial; state covers 100% for terminally ill patients, otherwise 50% up to a DKK 10,000 annual cap

Regulatory Overview

Denmark ran a four-year medical cannabis pilot (forsøgsordningen) from 1 January 2018, extended once, and scheduled to expire 31 December 2025. Bill L135 was introduced on 6 February 2025, adopted at third reading on 24 April 2025, received royal assent as LOV nr 439 af 06/05/2025, and entered into force on 1 January 2026, making the scheme permanent.

The permanent framework made two substantive changes beyond continuity: any licensed physician may now prescribe on clinical judgement without reference to a predefined diagnosis list, and cannabis cultivated anywhere in the EU/EØS may be imported for further processing in Denmark, where previously certain product categories required domestically grown bulk.

Patient Access Pathways

Four legally distinct routes, which the DMA treats separately for statistics and reimbursement:

Pathway (Danish term) Description Named products
Ordningen med medicinsk cannabis The scheme proper — products that are neither authorised medicines nor magistral preparations Dried flower, oromucosal liquid, capsules
Godkendt medicin Fully authorised medicines Sativex®, Epidyolex®
Udleveringstilladelse Compassionate use; the doctor applies to the DMA per patient and the product is imported Cesamet® (nabilone), Marinol® (dronabinol)
Magistrelt fremstillet medicin Pharmacy-compounded for a named patient — THC or CBD as active substance Compounded, no brand

Licence Types

All authorisations are issued by the DMA. Requirements are set by executive order: BEK nr 1607 af 05/12/2025 (bulk and starting products) and BEK nr 1608 af 05/12/2025 (intermediate products), both of which replaced their 2021 predecessors on 1 January 2026.

Authorisation Permits Requirements
Manufacturing permit (BEK 1607) Manufacture of cannabis bulk and starting products. Cultivation is an optional activity on this same permit, not a separate licence Premises and quality system per BEK 1607; a qualified person; a safety-responsible person; police vetting of owners, director and safety officer; mandatory pre-licence inspection
Intermediate manufacturer’s permit (BEK 1608) Manufacture of cannabis intermediate products Premises and quality system per BEK 1608; a qualified person. No safety-responsible person, no probity vetting, inspection discretionary
Development-scheme authorisation (udviklingsordningen) Cultivation and handling for development purposes only — may not supply patients or export Application plus a project description; DMA inspection. Sits outside the cannabis Act, under § 2(2) of the Act on Euphoriant Substances

A qualified person needs a four-year degree plus two years’ relevant experience, or a five-year degree plus one year.

Every scheme permit is in practice a double licence: the permit under § 9(1) of the Act, plus a euphoriant-substances authorisation, because cannabis is List B item 83 (with an exemption at or below 0.2% THC). The cultivation authorisation is issued only together with a manufacturing permit.

Processing Times

Step Stated period
Manufacturing / intermediate permit 90 days
Permit variation 30 days (minor) / 90 days (major)
Product admission — validation 14 days
Product admission — assessment, imported starting product 50 days
Product admission — assessment, domestically produced 70 days
Assessment after a deficiency reply 40 days (imported) / 60 days (domestic)

Validation and assessment run sequentially, not concurrently, so a domestic product admission is 14 + 70 days before any deficiency round.

Terminology

The scheme distinguishes four product stages, and the licence types map onto them:

  • Cannabis bulk — processed cannabis that is neither a starting nor an intermediate product, made for further processing, packaging, or export.
  • Cannabis starting product (cannabisudgangsprodukt) — manufactured from the plant; herbal teas, oils, capsules.
  • Cannabis intermediate product (cannabismellemprodukt) — made by an intermediate manufacturer from a starting product, to become a final product.
  • Cannabis product — prepared by a pharmacy against a patient’s prescription.

Fee Schedule

Fee item DMA published 2026 (DKK) BEK 1585 Bilag 1 (DKK)
Application — manufacturing permit, with cultivation 147,909 130,301 (no split)
Application — manufacturing permit, without cultivation 142,222 item absent
Application — intermediate manufacturer’s permit 79,950 70,432
Application — development scheme 49,594 43,690
Annual — manufacturing permit, with cultivation 60,847 53,603 (no split)
Annual — manufacturing permit, without cultivation 47,198 item absent
Annual — intermediate manufacturer’s permit 47,198 41,579
Annual — development scheme 15,102 13,304
Product admission — imported starting product 56,059 49,385
Product admission — domestically produced starting product 143,633 126,533
Annual — admitted intermediate and its starting product 40,150 35,371

No import/export certificate fee could be located in any primary source. Secondary sources cite DKK 1,625; that figure is unverified and is not reproduced here as fact.

Programme Metrics

Unique patients in the scheme proper, by year:

Year Unique patients Source
2018 1,211 Trial evaluation, Nov 2024, Table 3.1
2019 1,705 Trial evaluation, Nov 2024, Table 3.1
2020 812 Trial evaluation, Nov 2024, Table 3.1
2021 706 Trial evaluation, Nov 2024, Table 3.1
2022 768 Trial evaluation, Nov 2024, Table 3.1
2023 1,323 DMA monitoring report, 25 Nov 2025
2024 1,605 DMA monitoring report, 25 Nov 2025

Indications: neuropathic pain accounts for 97.8% of prescriptions (18,323 of 18,741) when all five neuropathic-pain codes are summed. The commonly quoted “90%” reflects a single code and understates the concentration.

Industry, as at October 2025: 9 companies hold permits to produce cannabis bulk and starting material, and 9 hold intermediate-product permits. The DMA’s live admitted-products list held 14 products as at 22 June 2026, of which only two to three are Danish in origin; every dried-flower product on the list is Dutch.

Exports are certificated and published by the DMA half-yearly from 2021 onward: 1,450 kg in H1 2021, rising to 2,825 kg in H2 2022, with 5,313 kg for full-year 2022. The published series excludes products at or below 0.2% THC and laboratory samples, and does not extend before 2021. No Danish-side series has been located for 2024–2025.

Data Surface

Data surface Available? Official source Machine-readable? Notes
Admitted product list yes DMA medicinal cannabis programme pages no HTML list; counted directly, 14 as at 2026-06-22
Licence registry partial DMA reference-group minutes no Counts published in meeting materials, not a registry
Testing-laboratory registry no public source located — — Quality governed by GMP, no separate public list
Laboratory testing rules yes BEK 1607 / BEK 1608 no Codified in executive orders
Contaminant/action limits partial Pharmacopoeial monographs via GMP no Not cannabis-specific Danish limits
Recalls/advisories partial DMA medicines recalls partial Covers medicines generally
Fees yes DMA fees page and BEK 1585 Bilag 1 no Two conflicting schedules — see above
Patient/prescription statistics yes Trial evaluation (Nov 2024); DMA monitoring report (Nov 2025) no PDF tables; strong time series
Export volumes partial DMA half-yearly certificated exports no 2021–2023 only
Open-data downloads no public source located — — No cannabis open-data portal

Future Ingestion Opportunities

  1. Admitted-products list — the highest-value target. Small, current, product-level, and it maps directly onto the archive’s product model.
  2. Patient and prescription series — the November 2024 evaluation and the November 2025 monitoring report together give 2018–2024 annual coverage with half-year granularity.
  3. Fee schedule reconciliation — worth tracking as a live discrepancy; the DMA page and BEK 1585 should converge and currently do not.
  4. Reference-group minutes — the only published source for licensee counts; monitor for a real registry.

Sources & Provenance

Market valuations circulated by commercial analysts are not reproduced here; none could be traced to an official statistic.

Graph Connections

No existing repository entities are linked to Denmark yet. The page is discoverable from the Jurisdictions index.