Denmark Pharmaceutical Licensing

This record focuses on pharmacies/non-pharmacy retail, wholesale and manufacturing of human medicinal products in Denmark. Retail has at least two distinct pathways: pharmacy business is governed by the pharmacy licence system, while sales outside pharmacies of specified OTC and other non-pharmacy-restricted medicines require DMA company authorisation. Neither pathway automatically includes wholesale, manufacturing, work by individuals, product marketing authorisation, imports from third countries or controlled-substance activities.

DMA company authorisations are issued only to companies domiciled in Denmark. Each address where activities are actually carried out is treated as a site, and multiple sites may be listed under the same authorisation. Official sources verified the requirements concerning a Danish domicile and actual locations, but the sources reviewed for this article did not confirm general requirements on company form, minimum capital or foreign ownership restrictions; no such conditions should be added without evidence.

— Pharmacy licence: pharmacy business and its statutory associated units.

— Company authorisation: apply separately by activity for OTC retail outside pharmacies, WDA, MIA and other activities.

— Verify separately: company registration, individual work/residence status, product marketing, imports/exports and controlled substances.

The DMA is the central medicines authority for the three main pathways covered by this record: company authorisation documents are reviewed by its Authorisations & Security of Supply department, and the DMA also handles pharmacy licences. The legal basis for company authorisations includes EU regulations, the Danish Medicines Act and legislation concerning controlled substances; manufacturing and import, and wholesale, are governed respectively by GMP/GDP implementing orders and EU rules.

Pharmacy rules are separate from general company authorisations. The official Pharmacy Business Act provides that the DMA decides on the establishment, closure and relocation of pharmacies, including pharmacies operating exclusively online. Denmark is not a federal/state decentralised licensing system of the kind described in this record; this guide does not present local examples as nationwide rules.

— DMA: pharmacy licences, company authorisations, inspections, fees and certain product regulation.

— Retsinformation: Denmark's official portal for consulting legal texts.

— European Commission: certain medicinal products may obtain marketing authorisation through the EU centralised procedure.

Pharmacy business must be conducted through the statutory route, including a pharmacy licence. To operate a pharmacy, an application must be made for an available licence published by the DMA; the DMA assesses the applicant and decides whether to grant it. A pharmacy is operated by an individual pharmacy proprietor holding a licence at a specified location, and selling prescription medicines to consumers is exclusive to pharmacies.

Retail outside pharmacies is not an unregulated space. The DMA's general guidance on company authorisations lists “retail sale of non-pharmacy-restricted medicines outside pharmacies”, covering specified OTC and other products; the official fee schedule also lists authorisation for OTC retail separately. When human medicinal products are sold online, pharmacies and authorised retailers must display the green EU logo, be listed by the DMA and have notified the DMA of their online sales.

— Pharmacy licence application: apply only for an available licence published by the DMA; acquiring inventory or leasing a shop cannot replace an application.

— Retail outside pharmacies: limited to the relevant authorised range of medicines; do not assume that prescription medicines or all OTC medicines may be sold.

— Online retail: the green logo, listing by the DMA and notification of online sales are compliance-identification requirements for websites selling human medicinal products.

A WDA covers the purchase, sale, receipt, storage and supply within the European Economic Area of finished medicinal products that have been batch-released, as well as authorised exports to third countries. Even if a company only buys and sells without physically possessing medicinal products, or outsources receipt, storage or supply, it may still require a WDA and must retain GDP responsibility.

Receiving or purchasing medicinal products from a third country is outside the scope of a WDA; only a manufacturing company with an MIA covering the relevant import activity may handle those imports, and the medicinal products must be batch-released by an authorised QP. A WDA also does not permit handling unreleased medicines or intermediates.

— New WDA: complete application form, organisational chart and premises overview; where a contractor is used, approval documents for the contractor must also be submitted.

— GDP: the quality system, responsible person, supplier/customer qualification, complaints and recalls, self-inspections, temperature control and transport controls should be proportionate to the scale and complexity of the business.

— Outsourcing: a contract cannot transfer GDP responsibility; any new contractor must first be approved by the DMA and listed in the authorisation annex.

The DMA issues MIAs under section 39 of the Medicines Act. The application form has separate annexes for human and veterinary medicines, marketed medicines and investigational medicines, and manufacture and import from third countries; a separate form must be completed for each site. Manufacturing activities, packaging, testing and batch release must all be accurately specified; an MIA may also be required solely for storing intermediate products, bulk products or medicines not yet released.

A new MIA application must include the application form, Site Master File, QP authorisation documents and a list of contractors. The DMA normally inspects before granting authorisation; all GMP facilities under section 39 are subject to risk-based inspection, with the risk assessment taking into account process and product complexity, the criticality of the activities and previous inspection findings.

— Medicinal products manufactured in-house and batch-released by the company may be wholesaled within the scope of the MIA; medicinal products released by another manufacturer require a separate WDA.

— Contract manufacture/testing: the contracting company remains responsible for GMP/GDP, must confirm that the contractor has valid regulatory approval, conduct an audit and enter into a technical agreement.

— Cessation of operations: an MIA cannot be terminated outright if the company continues to retain reference samples, control samples or batch documentation, or remains responsible for complaints and recalls.

Pharmacy licences involve an assessment of the individual applicant’s suitability, but personal authorisation for pharmacy employees is a separate matter. The DMA explicitly states that Denmark has no general registration system for pharmacists and pharmacy technicians; persons qualified as pharmacists or pharmacy technicians abroad who work in a community or hospital pharmacy must apply separately to the DMA for authorisation and should have sufficient Danish-language ability to practise safely.

There is no uniform requirement for a WDA responsible person to hold a pharmacy degree, but the person should be competent to perform the role. An MIA must have at least one DMA-authorised QP listed on the MIA. A QP for human medicines must have a relevant scientific qualification and experience in pharmaceutical manufacturing, QA or QC; the required years of experience and duration of education are determined under DMA rules.

— Pharmacy: confirm separately the pharmacy licence, work authorisation for pharmacy employees, and residence/work permits.

— WDA: one RP for human medicines; duties may be delegated, but responsibility cannot be delegated.

— MIA: the QP must be authorised by the DMA for the specific company; foreign qualifications must also be submitted to the Danish higher education authority for assessment in accordance with DMA guidelines.

For company authorisations, the DMA treats the address where activities actually take place as the site and requires the company to have a registered legal address. WDA applicants must have a physical address in Denmark where wholesale activities are substantively carried out; a c/o address or vacant office is not accepted. The DMA must be able to inspect at any time at the location stated in the authorisation.

A new company authorisation applicant must be able to demonstrate the relevant capability at the time of filing, and the premises, facilities, equipment and procedures at each site must be ready. WDA premises must have completed temperature mapping and established monitoring; each MIA manufacturing/import site must be declared separately, and the manufacturing locations must be described in the SMF. Pharmacy locations are governed separately by the Pharmacy Business Act.

— WDA: storage, temperature control, receipt, quarantine, transport, cleaning and record-keeping arrangements should be established in accordance with GDP.

— MIA: premises, facilities, equipment, documentation and the GMP quality system must match the activities declared.

— Pharmacy: the operating location must be reported within the DMA deadline when the pharmacy is established; the DMA may decide on establishment, relocation or closure.

There are four types of company authorisation procedure: new application, variation, renewal (if the authorisation has a term) and termination. Applications may be made using an electronic form, or by sending the DMA a signed PDF application form, a covering letter/email explaining the reason for the application, and relevant materials. A new application must be inspection-ready when submitted, and the application form must provide a complete snapshot of the activities proposed.

A new WDA application should include the completed application form, organisation chart and premises overview; where contractors are used, it must also include the contractor’s authorisation, contract and audit findings, among other materials. A new MIA application should include the application form, SMF, QP documents and contractor list. A pharmacy licence application must be made for a licence made available by the DMA; the DMA assesses applicants and makes a selection.

— First obtain or update the company and site identification details in the EMA Organisation Management Service, then proceed with the WDA/MIA application.

— WDA/MIA: prepare the documentation, site, quality system and personnel in parallel; the DMA normally inspects before granting authorisation.

— Pharmacy: available licences, individual suitability, operating location and takeover arrangements must be handled under the DMA’s case-specific procedure.

Under the DMA general rules on company authorisations, the maximum review period is 90 calendar days for complete new applications, renewals, terminations and variations requiring an inspection; the maximum is 30 calendar days for variations not requiring an inspection. This period runs from receipt of a valid application and the required materials. Clock-stop periods are excluded, and this is not the total timeline for site selection, construction, corrective actions or product launch.

The official DMA fee schedule lists application fees and annual fees for company authorisations, and the general rules state that most company authorisations have no expiry date but remain in force until amended or terminated. The amounts in the table below are the schedule values at the time of this verification. DMA states that application fees/annual fees are adjusted on 1/1 each year; the latest schedule should be checked before submission.

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After a company is authorised, it enters the DMA’s risk-based inspection programme. GMP inspections of manufacturing are risk-based, taking into account the complexity of manufacturing processes and products, the criticality of activities and previous inspection findings. Wholesale businesses should maintain a GDP quality system proportionate to their size and complexity, covering organisation, responsibilities, documentation, training, supplier/customer qualification, deviations, CAPA, complaints and recalls, self-inspection and outsourcing controls.

A pharmacy must continue operating within the framework of its licence and statutory location, and report its financial accounts to the DMA annually. If a WDA or MIA retains only inactive activities, it must still maintain the relevant procedures, premises, equipment and personnel training; an authorisation consisting solely of inactive activities cannot be retained long term, and the DMA’s general position is that cases should be handled individually after a maximum of six months without activity.

— MIA: GMP quality system, QP batch release, contractor management, reference samples/batch documentation and recall arrangements.

— WDA: GDP quality systems, temperature control, counterparty verification, complaint and recall handling, transport, and outsourced-activity management.

— Pharmacy: Ongoing compliance with operating, financial reporting, and DMA regulatory requirements.

For company authorisations, DMA approval must be obtained before implementing a change to the authorised scope. New activities, a new site, or relocation of an existing site generally require an inspection; changes to the company name or associated persons may not necessarily require an inspection, which DMA decides on a case-by-case basis. A new WDA contractor must be approved by DMA in advance; a new RP should be listed on the authorisation on the date they take over. MIA changes to the name, activities, address/new site, and QP each have a corresponding application route.

A pharmacy licence does not automatically continue as a result of a commercial transaction. The Pharmacy Business Act provides that DMA publishes vacancies for licences, receives applications, and makes selections; a licence expires upon the holder’s death, loss of statutory qualifications, or other statutory circumstances. The Act establishes separate rules for pharmacy takeover, temporary operation, and the handling of associated units. No official rule was found supporting the claim that a change in shareholding, assets, trade name, or lease automatically transfers all pharmacy, WDA, or MIA licences.

— WDA: Apply under the guidance before changing activities, address, site, contractor, or RP.

— MIA: Submit the relevant supporting documents when changing activities, address/new site, or QP; for a QP change, include education, subjects, CV, training plan, and applicable contract.

— Pharmacy: Confirm takeover, licence holder, opening, or relocation matters with DMA on a case-by-case basis before completion/commencement.

Before a medicinal product can be sold in Denmark, it must obtain a marketing authorisation from DMA or the European Commission. National, centralised, decentralised, and mutual-recognition procedures are four product-level routes; an application must demonstrate the medicinal product’s efficacy, safety, and quality. This authorisation is separate from pharmacy, retail, WDA, or MIA authorisations and cannot replace them.

Imports from third countries are handled through the MIA route; a WDA holder may not receive or purchase medicinal products from third countries. Each consignment of controlled substances (euphoriant substances) crossing a border requires an import or export certificate, and a valid company authorisation for import/export of controlled substances must already be in place before using NDS Web.

— Products: Confirm the marketing authorisation, indications, labelling, and applicable procedure for each SKU.

— Imports from third countries: Check the MIA import activity, QP batch release, re-analysis, and subsequent wholesale arrangements.

— Controlled substances: General retail, WDA, or MIA authorisation does not automatically cover these; company authorisation and consignment-by-consignment import/export certificates may both be required.