Sitemap

You must accept marketing cookies to share the page by mail

Update consent

Share by mail

Your email: Recipient's email:

• Licensing and supervision
  • Brexit
    • Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP)
    • Centralised authorisation procedure
    • Parallel import and parallel distribution
    • Nationally authorised medicinal products
    • Clinical trials
    • Marketed products
    • Compassionate use permits
    • Private individuals’ import of medicines from the UK
    • Questions and answers on Brexit
    • Links
  • Licensing of medicines
    • Crisis in Ukraine and assessment times
    • Regulatory guidance in connection with COVID-19 and assessment times
    • Enquiries to the Danish Medicines Agency about the status of submitted applications for medicinal products approved via DCP, MRP or national procedure
    • SPCs, package leaflets and labelling
      • Exemption from the requirements for labelling, implementation deadlines, package leaflets etc. for medicinal products
      • Pilot project on English-only common Nordic packages for human medicinal products
      • Guideline on the use of QRD templates for summaries of product characteristics, package leaflets and labelling of human medicinal products
      • Guidelines on the use of QRD templates for summary of product characteristics, package leaflet and labelling of veterinary medicines
      • Q & A about package leaflets and labelling
      • Upload package leaflets to DKMAnet
    • Marketing authorisation
      • Call to industry to Apply for Marketing Authorization for Selected Medicines
      • Marketing authorisations without Danish product information
      • National Scientific Advice
      • Application for marketing authorisation
      • Allocation of time slots (DCP)
      • Updating of documentation before start-up of MRP/RUP
      • Procedure for national applications
      • Sunset clause
      • Paediatric data
      • Guidelines for submission and technical validation of applications
        • Questions and answers on active substance and finished product manufacturer
    • Generic medicines (generics)
    • Receipt, acceptance and approval letters
    • Renewal of marketing authorisation
    • Safety features on medicinal products
    • Changing the legal status of a human medicinal product
    • Patented indications and substitution
    • Variations
      • Obligations regarding updates of Active Substance Master Files (ASMF/DMF)
      • Information on EDQM's procedure for withdrawal or suspension of Certificates of Suitability
      • Requirements for marketing authorisation holders for medicinal products containing active substances in the form of mesilates, (di)isetionates, tosilates or besilates
      • Temporary repackaging of medicines with a marketing authorisation
      • Questions and answers on variations after 1 January 2010
    • Parallel import and parallel trade
    • Deregistration
    • Parallel distribution
    • Naming of medicines
      • Implementation and authorisation of name changes
      • Questions and answers
    • Case statistics and order books
      • Number of cases
        • Centralised authorisation procedure 2021
        • Centralised authorisation procedure 2022
        • Centralised authorisation procedure 2023
        • Centralised authorisation procedure 2023
        • Den decentrale anerkendelsesprocedure 2023
        • Decentralised recognition procedure 2023
        • Mutual recognition procedure 2023
        • Decentralised recognition procedure 2021
        • Decentralised recognition procedure 2022
        • Mutual recognition procedure 2021
        • Mutual recognition procedure 2022
      • Assessment times
        • Sagsbehandlingstider for godkendelse af parallelimport af lægemidler i 2024
        • Sagsbehandlingstider for nationale variationer 2024
        • Assessment times for issuance of marketing authorisations in Concerned Member State cases
      • Order books
        • Order Book National Type IB
        • Order Book National Type II
        • Procedure Start Date for National Variations
        • How to search in the order book
      • Completion of delayed cases in the licensing area
    • Lists of authorised and deregistered medicines
      • Authorised medicinal products
      • Deregistered medicinal products
    • Medicines authorised with a summary of the risk management plan
    • Medicinal products with educational material (EDUMAT)
      • Preparation and distribution of Danish educational material
      • Danish educational materials
    • Medicines under additional monitoring
  • Authorisation procedures
  • Company authorisations and registrations
    • Organisation data from OMS in EudraGMDP
    • Manufacture of medicines and intermediates
      • Legislation
        • Good Manufacturing Practices (GMP) - questions and answers
    • Wholesale distribution
      • Legislation
      • Questions and answers
      • Receipt control by wholesale distributors (GDP)
      • Approval of suppliers
    • Manufacture, importation and distribution of API
      • Annual update
      • Legislation
      • Import from third country
    • Euphoriant substances
      • Lists of substances
      • Import/export
      • Destruction
      • Reports
    • Medicinal cannabis pilot programme
    • Retail of medicinal products
    • Medical gases
    • Retail of medicinal products for livestock
    • Non-clinical trials (GLP)
      • GLP
    • Radiopharmaceuticals
    • Wholesale distribution of certain substances
      • Rules for activities with certain substances
    • Medicine chests for lifeboats and liferafts
    • Brokering of medicines
      • Questions and answers
  • Supervision and inspection
    • Inspection
      • Using AI/ML algorithms in GxP
      • Requirements to IT systems in GxP
    • Standardisation of the quality of medicines in Europe
      • Danish Drug Standards
        • Danish Drug Standards: Determining storage conditions for products
      • Pharmacopoeia Commission
      • Groups of experts- and working parties under the EDQM
    • GMP certificates
    • GDP certificates
    • Laboratory control
      • European laboratory cooperation
      • Accreditation of the DHMA's laboratory
    • Product defects and recalls
      • Reporting of product defects
      • Questions and answers on the recall of the antibiotic Dicillin from Sandoz
    • Medicine shortages
      • Stockpiles of critical medicines
        • Content of the stockpile obligation
        • Dispensation
        • Suspension of the stockpile obligation
        • Reporting of stock levels
      • Meddelelser om forsyning af medicin II
      • National Council for the Security of Supply of Medicines
    • Notification of medicine supply problems
    • Guideline on advertising
    • Publications
  • Clinical trials
    • What is a clinical trial?
      • The clinical trial phases
    • Questions and answers
    • Regulation for Clinical Trials
      • Registration of new investigational medicinal products in the EudraVigilance database (XEVMPD)
    • Substantial modifications
    • Assessment times
      • Case statistics
    • GMP and Quality of IMP
    • Non-clinical regulatory advice
    • Safety reporting during clinical medicinal trials
      • Reporting of suspected serious unexpected adverse reactions to the EudraVigilance database for clinical trials with medicinal products
      • Submission of annual safety reports for clinical trials
    • Transition of clinical trials from Directive to Regulation
    • Fees for clinical trials
    • Combined studies with a clinical trial and a simultaneous performance study
    • Decentralised Clinical Trials
    • Ongoing clinical trials under the Directive
      • Guideline for applications for authorisation of clinical trials of medicinal products in humans
      • Amendments to clinical trials
      • Fees
      • Cataloguing of active substances
      • Applications via Eudralink
    • End of trials with medicinal products and reporting of results
    • Trials in animals
    • GCP inspection
      • Storage and filing of essential documents
      • Source data list
      • ‘First in human’ clinical trials
      • Notification of serious or repeated non-compliance
      • Clinical trials under US legislation
      • Common deviations related to data-handling, etc. in investigator-initiated trials
      • Good documentation practice
    • Publications
  • How to evaluate evidence of the efficacy of medicines
  • Evaluation of reviews
  • Report suspected illegal activities
  • Falsified medicines
    • Safety features - handling of alerts
    • Pharmaceutical companies’ reporting
    • Questions and answers
  • Compassionate use
  • Medicine or not
    • Definitions of medicines and other product groups
    • This is how we assess your product
    • How to advertise your product
    • What is the function of your product?
    • Who to contact
    • Special classifications
    • List of products determined to be medicines
  • Export certificates
  • Fees
    • Application for annual fee exemption
    • Guidance for companies
    • Fees on euphoriant substances
    • Manufacturers outside the EU/EEA area
  • Name/address changes
  • Relationships
    • Doctors
    • Nurses
    • Dentists
    • Companies
    • Companylists
      • Proprietary pharmacists, doctors, nurses and dentists
  • Financial support
    • Healthcare professionals and specialists
    • Companies
    • List
  • Medicinal Products Committee
    • Dates of meetings
    • OTC medicines for sale outside pharmacies
  • Publications
• Side effects and product information
  • Side effects of medicines
    • Report a side effect
      • Humans
      • Animals
    • Registration and monitoring
    • EudraVigilance
    • Companies' reporting of side effects
      • Reports from the Danish Patient Compensation Association
      • Follow-up on adverse reaction reports
      • Applicable law
      • Questions and answers
      • Guidance on MedDRA version upgrade
    • Interactive Adverse Drug Reaction overviews
      • Search guidelines
    • Stricter reporting requirements
    • Compensation for pharmaceutical injuries
    • Pharmacovigilance and the EU cooperation
    • Childhood vaccines
      • HPV vaccination
    • Pharmacovigilance and inspections
    • Network for the Prevention of Medication Errors
    • Danish Pharmacovigilance Update
    • Publications
  • Additional monitoring
  • News on pharmacovigilance
  • Biological and biosimilar medicinal products
    • Reporting suspected adverse reactions from biological medicinal products
    • List of selected biological medicinal products
    • Frequently asked questions
  • Safety updates
  • Post Authorisation Safety Study
  • Direct Healthcare Professional Communication
    • Ikke udsendt i Danmark
    • Preparation, translation and distribution
  • Adverse events
  • Drug interaction
  • Pharmacovigilance Council
  • Find medicines
    • Summaries of product characteristics
    • Package leaflets
    • Lists with information about medicines
  • Publications
• Reimbursement and prices
  • General reimbursement
    • Medicines eligible for reimbursement
    • Application
      • Health economic analyses in reimbursement applications
    • Decisions
    • Reassessment
      • Background information
      • Consumption analyses
  • Individual reimbursement
    • Single reimbursement
      • Guiding criteria
    • Increased reimbursement
    • Reimbursement for the terminally ill
    • Social subsidies
  • Calculate reimbursement
    • Reimbursement thresholds
    • Reimbursement prices
  • Medicines bought in another EU/EEA country
  • Reimbursement Committee
    • Dates of meetings
    • Publications
  • The EU HTA regulation
    • National steering group for HTA regulation
    • National organization Q&A
  • Prices of medicines
    • Search for prices
      • Calculate your co-payment
      • About Medicinpriser.dk
    • Medicine Prices for companies
      • Example of medicine price files
    • Notification of prices and range
      • Guideline for creating XML-files
      • Listing of centrally authorised products
      • Package and range: Minimum price changes
      • Package and range: Notification of supply capacity
      • Deadlines
      • Notification of prices in relation to advertising
      • Emergency forms
    • Notification of supply failure
    • Medicinal product groups - substitution groups
    • Conversion to consumer price
  • Product numbers
  • Central Reimbursement Register
    • Outstanding amounts
  • Reimbursable nutritional products
    • Application for reimbursement
  • Publications
• Pharmacies and sale of medicines
  • Pharmacies
    • The Danish Pharmacy Act
    • Over-the-counter sales outlets
    • GDP at pharmacies - Q&A
    • Dose dispensing
      • List of dose-dispensed medicines
      • Extended storage period
      • Approval of packaging
    • Magistral medicines
    • Reporting of drug misuse
    • Pharmacy licences
      • Consultants on the Appointment of Proprietor Pharmacists
    • Foreign pharmacy staff
      • Applying as a pharmacist qualified in the EU/EEA or Switzerland
    • Distributors of medicines for production animals
    • Subsidy for pharmacies
    • Fees
    • Publications
  • Sale outside pharmacies
    • Thresholds
    • Sale of over-the-counter medicines
    • Sale of over-the-counter medicines - questions and answers
    • Inspection of sale of over-the-counter medicines outside pharmacies
    • Medicines for production animals
    • Fees
    • Publications
  • Over-the-counter medicines
    • Over the counter medicine in self-selection
    • Over-the-counter painkillers
  • Substitution
  • Medicines imported from abroad
    • Warnings against products
    • Medicines for human use
      • Do you buy medicine online?
      • Are you bringing medicine into Denmark?
      • Are you importing medicine containing doping or euphoriant substances?
      • Import of medicines from the UK
    • Veterinary medicines
    • Do you consider buying potency enhancers?
      • List of illegal potency enhancers
    • Are you considering buying slimming pills?
      • List of illegal sibutramine-containing weight-loss products
    • Are you considering to buy melatonin online?
  • Buying and selling medicines online
    • Pharmacies selling medicines legally online
    • Buying medicines online
    • Authorised retailers selling human medicines online (green logo)
    • Authorised retailers selling veterinary medicines online (blue logo)
  • Sale of medicines or food supplements online
  • Doctors buying medicines for use in their own practices
  • Report suspected illegal sale of medicines
  • Prescriptions from another country
  • Publications
• Medical devices
  • Incident reporting
    • Manufacturers' reporting
    • Distributors' and importers' reporting
  • New regulations
    • Changes as a result of the EU regulation on in vitro diagnostic medical devices
    • Extension of transitional provisions related to in vitro diagnostic medical devices (IVD)
  • COVID-19 antigen test for self-test
    • CE marking of IVDs
    • Classification of in vitro diagnostic medical devices (IVD)
  • Advice to consumers on buying face masks
    • Information for companies on face masks
      • Sterile and non-sterile face masks
      • Requirements for labelling, language and instructions for use
      • Guidelines on handing out free face masks
      • FAQ on the repackaging of face masks for resale
  • New Tech – new technological possibilities and medical devices
    • FAQ on AI in medical devices
  • Patient safety and safe medical devices
  • Development of medical devices
  • Regulatory advice for medical device companies
  • CE marking
  • Notified bodies
    • Consultation procedure for medical devices containing medicinal substances
  • Registration and marketing
    • Marketing and advertising
    • Language requirement
    • Derogation from CE marking
  • Clinical investigations
    • Notification duty
    • Application
    • Information about the assessment
    • Notification of PMCF investigation
    • Application for authorisation of substantial modifications
    • Reporting of SAEs
    • Completion of investigation
    • Fees
  • Performance studies of in vitro diagnostic medical devices (IVDs)
    • Application for the authorisation for performance studies of in vitro diagnostic medical devices
    • Combined studies with a clinical trial and a simultaneous performance study
    • Fees for performance studies of in vitro diagnostic medical devices
  • Certificates of Free Sale
  • Legislation and guidance
    • Legislation
    • Guidance
    • European Directives
    • Commission guidance
    • Harmonised standards for medical devices
    • Medical devices used for animals
  • Publications
• Special product areas
  • Veterinary medicines
    • Theme page about the new veterinary medicinal products regulation
    • Changing the legal status of a human medicinal product
  • Natural medicinal products and vitamin and mineral products
    • Natural medicinal products
    • Vitamin and mineral products
  • Euphoriant substances
  • Medical gases
  • Radiopharmaceuticals
  • Medicines affecting the ability to drive
    • Red warning triangle
  • Medicinal cannabis
    • Questions and answers on medicinal cannabis
    • Medicinal cannabis pilot programme
      • Graphical overview of the medicinal cannabis pilot programme
      • Cannabis products in the pilot programme
        • Reimbursement and prices of cannabis products in the pilot programme
        • Side effects and safety of medicinal cannabis
        • Admission of products to the medicinal cannabis pilot programme
        • Ban on advertising
      • Manufacturing
        • Authorisation to manufacture cannabis bulk and cannabis primary products
        • Authorisation to manufacture cannabis intermediate products
        • Record-keeping and destruction of cannabis
      • The role of the pharmacies
      • Proprietary pharmacists' and doctors' relationships with companies
        • Doctors’ relationships with companies
        • Proprietary pharmacists’ relationships with companies
        • Rules about relationships applicable to companies
      • Guidelines for doctors
      • Medicinal cannabis reference group will gather stakeholders
    • Development authorisation
      • Development authorisation
        • Questions and answers on the development scheme
        • Record-keeping and destruction of medicinal cannabis
    • Fees
  • Regulation of innovative medicinal products including ATMP
• About us
  • Mission, vision and strategy
    • Value-adding knowledge sharing and administrative processes
    • Better use of data and new technology
    • International involvement
    • Great place to work
  • Contact
    • Press room
    • Use a secure connection to contact us
    • Information Centre
    • 24-hour hotline
    • Parking
    • Suspected illegal activities
    • EAN number, CVR number and bank details
    • Request access to documents
    • Secure emails
  • Organisation
    • Our leadership team
  • Whistleblowing scheme of the Danish Medicines Agency
    • Statistics for the Whistleblowing scheme
  • The Danish Medicines Agency funding
  • Management of conflicts of interest
  • Transparency in the Danish Medicines Agency
    • Search declarations of interests
    • Form for Conflicts of interests
  • Data protection policy
    • Personal data policy for newsletter subscribers
    • Data protection and the Danish Medicines Agency's use of social media
    • Privacy policy for the Medicintjek app
    • How the Danish Medicines Agency uses personal data – for healthcare professionals
  • Targets and tasks
    • Legislation
      • The Danish Medicines Act
      • The Danish Act on Clinical Trials of Medicinal Products
    • Annual accounts
    • Committees and councils
    • Tenders
    • Non-disclosure agreement
  • International collaboration
  • Jobs
    • Under the microscope
  • Digital services
    • Forms
    • About DKMAnet
      • DKMAnet - questions and answers
    • Reuse of data in e-forms
  • About this site
  • Social media
    • Social media guidelines of the Danish Medicines Agency
  • Design
  • Campaigns
  • Copyright
  • Cookies
  • Publications
  • Sitemap
• Publications
  • Order publications
  • 2024
  • 2023
  • 2022
  • 2020
  • 2019
  • 2018
  • 2017
  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
  • 2009
  • 2008
  • 2007
  • 2006