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
- Admitted-products list — the highest-value target. Small, current, product-level, and it maps directly onto the archive’s product model.
- Patient and prescription series — the November 2024 evaluation and the November 2025 monitoring report together give 2018–2024 annual coverage with half-year granularity.
- Fee schedule reconciliation — worth tracking as a live discrepancy; the DMA page and BEK 1585 should converge and currently do not.
- Reference-group minutes — the only published source for licensee counts; monitor for a real registry.
Sources & Provenance
- Statute: LOV nr 439 af 06/05/2025 — https://www.retsinformation.dk/eli/lta/2025/439 (in force 1 Jan 2026), amending LOV nr 1668 af 26/12/2017
- Bill: L135, adopted at third reading 24 April 2025 — https://www.retsinformation.dk/eli/ft/202413L00135
- Executive orders: BEK nr 1607 af 05/12/2025 (bulk/starting products); BEK nr 1608 af 05/12/2025 (intermediate products); BEK nr 1585 af 05/12/2025 (fees); BEK nr 405 af 26/03/2026 (euphoriant substances)
- Regulator: Lægemiddelstyrelsen — https://laegemiddelstyrelsen.dk/da/special/medicinsk-cannabis/ (Danish pages; English pages are stale as at 2022)
- Statistics: Evaluering af forsøgsordningen med medicinsk cannabis, Ministry of Interior and Health, November 2024; DMA monitoring report, 25 November 2025
- Retrieval date: 2026-08-10
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.