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
    • Regulatory guidance in connection with COVID-19 and assessment times
    • SPCs, package leaflets and labelling
      • Q & A about package leaflets and labelling
      • Upload package leaflets to DKMAnet
        • Medicinal product with no package leaflet
    • Marketing authorisation
      • 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
      • Format requirements
    • 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
    • Parallel import
    • 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 2020
        • Decentralised recognition procedure 2020
        • Mutual recognition procedure 2020
      • Assessment times
      • Order books
        • National type II Quality
        • Procedure start – National Variations
        • How to search in the order book
    • Lists of authorised and deregistered medicines
      • Authorised medicinal products
      • Deregistered medicinal products
    • Medicines authorised with a summary of the risk management plan
    • Educational materials for medicinal products
      • Preparation and distribution of educational material
    • Medicines under additional monitoring
  • Authorisation procedures
  • Company authorisations and registrations
    • Company authorisations
    • Company registrations
    • Manufacture of medicines and intermediates
      • GDP and GMP
        • Good Manufacturing Practices (GMP) - questions and answers
        • GMP requirements for manufacturers of active pharmaceutical ingredients (APIs) - questions and answers
      • Authorisation of several qualified persons on section 39 authorisations - questions and answers
    • Registration as manufacturer, importer and distributor of active substances (APIs)
      • Rules for active substances
      • Import from third country
      • Questions and answers
      • Annual update
    • Wholesale distribution
      • Good distribution practice (GDP)
      • Questions and answers
      • Receipt control by wholesale distributors (GDP)
      • Approval of suppliers
    • Brokering of medicines
      • Questions and answers
    • Distribution of medicines outside pharmacies
    • Medical gases
    • Veterinary medicinal substances
    • Euphoriant substances
      • Lists of substances
      • Forms
    • Radiopharmaceuticals
    • Toxicological and pharmacological trials
      • GLP
  • Supervision and inspection
    • Inspection
      • Using AI/ML algorithms 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
    • Medicine shortages
      • Notifications about the supply of medicines
    • Notification of medicine supply problems
    • Guideline on advertising
    • Publications
  • Clinical trials
    • Clinical trials of medicinal products
      • The clinical trial phases
    • Trials in humans
      • 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 trial notification and publication of results
    • Questions and answers
    • Clinical trials of the future place the patient at the centre
      • Forum for dialogue on decentralised clinical trials
    • New European clinical trial legislation is under way
    • 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
      • Should record notes be signed?
      • Good documentation practice
    • Assessment times
      • Case statistics
    • 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
    • Questions and answers
  • 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
  • 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 ADR
      • 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
  • Direct Healthcare Professional Communication
    • Ikke markedsført i Danmark
    • Preparation, translation and distribution
  • Adverse events
  • Drug interaction
  • Pharmacovigilance Council
  • Find medicines
    • Medicintjek: mobile app
    • 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
  • Prices of medicines
    • Search for prices
      • Calculate your co-payment
    • 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
      • 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
    • Do you want to import medicines?
    • 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
    • Medicines for animals
    • Was your medicine seized by customs?
    • 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
    • Retailers selling medicines legally online
  • 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
  • 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
  • Patient safety and safe medical devices
  • Development of medical devices
  • CE marking
  • Incident reporting
    • Manufacturers' reporting
    • Distributors' and importers' reporting
  • Notified bodies
  • Registration and marketing
    • Manufacturers of medical devices
    • Manufacturers of in vitro diagnostic devices (IVD)
    • Distributors and importers
    • Changes in company information or information about marketed devices
    • Deregistration
    • Specialised stores
    • Marketing and advertising
    • Collaboration with healthcare professionals
    • Language requirement
  • Clinical investigations
    • Regulatory requirements
    • Introduction
      • Notification by healthcare professionals
      • Clinical investigations including medicinal product tests
    • Application
    • Amendments to application
    • Fees
  • Certificates of Free Sale
  • Legislation and guidance
    • Legislation
    • New regulations
    • Book a meeting
    • Guidance
    • European Directives
    • Commission guidance
    • Other regulation
  • Publications
• Special product areas
  • Veterinary medicines
    • Medicated feed
  • 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
    • Citizens
      • What is medicinal cannabis?
      • Medicinal cannabis pilot programme
      • Graphical overview of the medicinal cannabis pilot programme
      • Prices of cannabis products in the pilot programme
      • Questions and answers on medicinal cannabis
      • Proprietary pharmacists' and doctors' relationships with companies
      • Side effects and safety of medicinal cannabis
        • Report a side effect of cannabis products
      • Change of the THC limit as of 1 July 2018
      • Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019
    • Healthcare professionals
      • Guidelines for doctors
      • Which cannabis products can be prescribed?
      • The role of the pharmacies
      • Accumulation of scientific knowledge
        • Accumulation of scientific knowledge, funds (first allocation)
        • Accumulation of scientific knowledge, funds (second allocation)
      • Adverse reactions and safety of medicinal cannabis
        • Report adverse reactions of cannabis products
        • Adverse drug reaction overviews for cannabis end-products
      • Proprietary pharmacists’ and doctors’ relationships with companies
        • Doctors’ relationships with companies
        • Proprietary pharmacists’ relationships with companies
    • Companies
      • Pilot programme
        • Rules about relationships to companies
      • Development scheme
• About us
  • Mission, vision and strategy
  • Contact
    • Media contacts
    • Use a secure connection to contact us
    • Information Centre
    • Telephone directory
    • 24-hour hotline
    • Parking
    • Suspected illegal activities
    • EAN number, CVR number and bank details
    • Request access to documents
    • Secure emails
  • Organisation
    • Data Analytics Centre (DAC)
  • Whistleblowing scheme of the Danish Medicines Agency
  • 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
  • Targets and tasks
    • Legislation
      • The Danish Medicines Act
      • The Danish Act on Clinical Trials of Medicinal Products
    • Annual accounts
    • Performance contracts
    • Committees and councils
      • Networks and task forces
    • International collaboration
    • Tenders
  • Activities in the EU and the rest of the world
    • Invitation to the Danish Medicines Agency's market dialogue on the future platform about a possible future PV system.
  • Jobs
    • Would you like a job in innovation and research?
  • Digital services
    • Forms
    • About DKMAnet
      • DKMAnet - questions and answers
    • Reuse of data in e-forms
  • About this site
  • Design
  • Campaigns
  • Copyright
  • Cookies
  • Publications
  • Sitemap
• Publications
  • Order publications
  • 2020
  • 2019
  • 2018
  • 2017
  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
  • 2009
  • 2008
  • 2007
  • 2006