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• Authorisation and supervision
  • Licensing of medicines
    • Summaries of product characteristics, package leaflets and labelling
      • Upload package leaflets to DKMAnet
    • Marketing authorisation
      • Request for scientific advice
      • Application for marketing authorisation
      • Status for time slot allocation
      • Validation of applications
      • Updating of documentation prior to initiation of MRP
      • Procedure for national applications
      • Sunset clause - initiation or cessation of marketing
      • Paediatric data
    • Renewal of marketing authorisation
    • Variations
    • Parallel import
    • Deregistration
    • Parallel distribution
    • Naming of medicines
      • Practice for implementation and authorisation of name changes
    • Case statistics and order books
      • Number of cases on the authorisation of medicinal products
      • Assessment times
      • Order Books
    • Lists of authorised and deregistered medicines
    • The Licensing Committee
      • Minutes
      • Dates of meetings
  • Company authorisations and registrations
    • Company authorisations in general
    • Company registrations in general
    • Manufacture and import of medicines and intermediates
      • Qualified person
      • GDP and GMP
    • Manufacture, import and distribution of active substances
      • Rules for active substances
    • Wholesale distribution
      • Receipt control of company authorisation
    • Brokering of medicines
    • Distribution of medicines outside pharmacies
      • Medicinal gasses
    • Blood establishment activity
    • Tissue establishment activity
    • Euphoriant substances
      • Lists of euphoriant substances
      • Activities
      • Import and export
      • Destruction
    • Radiopharmaceuticals
    • Toxicological and pharmacological trials
      • GLP
  • Supervision/inspection
    • Form for reporting pharmacovigilance activities in 2013
    • Inspection of authorised pharmaceutical companies
    • GMP certifikat
    • Medicines control
      • European laboratory cooperation
      • Accreditation of the DHMA's laboratory
    • Danish Drug Standards
    • Product defects and withdrawals
      • Reporting of product defects
    • The Danish Pharmacopoeia Commission
      • Meetings of the European Pharmacopoeia Commission
  • Compassionate use
    • Application - medicines for human use
    • Application - medicines for veterinary use
    • Experimental treatment with medicinal products
  • Definition of a medicine
    • Getting started
    • Medicinal product or borderline product
    • This is how we assess your product
    • How to advertise your product
    • What is the function of your product?
    • Who to contact
    • Special classifications
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  • Fees
    • Application for annual fee exemption
    • Fees on euphoriant substances
  • Export certificates
  • Name/address changes
• Side effects and trials
  • Side effects
    • Report a side effect or incident
      • Humans
      • Animals
      • Blood and blood products
      • Tissues and cells
      • Clinical trials
    • Additional monitoring
    • Registration and monitoring
    • Companies' reporting of side effects
      • Spontaneous adverse reaction reports
      • EudraVigilance
      • Follow-up on adverse reaction reports
    • Drug Analysis Prints: reported adverse reactions
    • Medicines with stricter reporting requirements for doctors, dentists and veterinarians
    • Compensation for pharmaceutical injuries
    • Positive experience with ADR reporting
    • The Danish Pharmacovigilance Council
    • The Council for Adverse Drug Reactions
    • The EU Pharmacovigilance Risk Assessment Commitee (PRAC)
    • Drug interaction
  • Clinical trials
    • Trials in humans
      • Applying via DKMAnet
    • Trials in animals
    • Inspection of clinical trials (GCP inspection)
      • Storage and filing of essential documents
      • Source data list
      • ‘First in human’ clinical trials
      • Notification of serious or repeated non-compliance
    • Cataloguing of active substances
    • Assessment times
    • Fees
    • Applications on CD-ROM or via Eudralink
    • Clinical trials - questions and answers
  • Adverse events
    • Network for the Prevention of Medication Errors
  • Safety updates
    • EU synchronisation of PSUR submission
  • Direct Healthcare Professional Communication
    • Delivered DHPCs
    • Preparation of DHPCs
• Retail and online sale
  • Pharmacies
    • Pharmacy licensing
    • Dose dispensing
      • List of dose-dispensed medicines
      • Extended storage period
      • Approval of packaging
    • Fees
    • List of distributors of medicines for production animals
    • Over-the-counter sales outlets
    • Reporting of drug misuse
    • Subsidy for pharmacies
    • Foreign pharmacy staff
    • Consultants on the Appointment of Proprietor Pharmacists
  • Sale outside pharmacies
    • Over-the-counter medicines and V-marked medicines
    • Medicines for production animals
    • Fees
  • OTC medicines
  • Importing medicines
    • Medicines retained by customs
      • Examples of medicines retained by Danish customs
    • EU/EEA countries
    • Inquire about import
  • Medicines online
    • Reliable information
  • Counterfeit medicines
    • Pharmaceutical companies’ reporting
• Prices and reimbursement
  • Prices of medicines
    • Search for prices on medicinpriser.dk
      • Calculate your co-payment
    • Medicine Prices for companies
      • Example of medicine price files
    • Notification of prices and range via DKMAnet
      • Guideline for creating XML-files
      • Listing of centrally authorised products
      • Minimum price changes
      • Notification of supply capacity
      • Deadlines
      • Emergency forms
    • Notification of supply failure
      • Emergency form for notification of supply failure
    • Medicinal product groups - substitution groups
    • Conversion from PPP to ESP (consumer price)
    • Price development
  • Reimbursement
    • General reimbursement
      • Medicines eligible for reimbursement
      • Application
      • Decisions
      • Reassessment
    • Individual reimbursement
      • Single reimbursement
      • Increased reimbursement
      • Reimbursement for the chronically ill
      • Reimbursement for the terminally ill
      • Social subsidies
    • Calculate reimbursement
    • CTR - the Central Reimbursement Register
    • Reimbursement thresholds
    • Reimbursement prices
    • The Reimbursement Committee
      • Minutes
  • Substitution
  • Product numbers
  • Statistics
    • Analyses
      • Medicine consumption in the primary healthcare sector
      • Consumption analyses
• Temaer
  • DCP time slots
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  • Medicintjek-app
  • Changes of reimbursement for medicine
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  • We are building a new website
  • Facts about influenza
    • Influenza: A viral infection
    • The ABC of influenza - the three types
    • Possible side effects of the influenza vaccine
    • Transmission and spread
    • What to do if you fall ill
    • The WHO keeps an eye on the world's influenza virus
    • Influenza A (H1N1) - questions and answers
• News
  • Subscribe to our newsletters
  • Danish Pharmacovigilance Update
  • Indication
• Product areas
  • Medical devices
  • Veterinary medicines
    • Task force on medicines for production animals
    • Veterinary premix and medicated feed
  • Herbal medicines, vitamins and minerals
    • Herbal medicinal products
    • Vitamins and mineral preparations
  • Blood and blood products
  • Tissues and cells
    • Register of authorised tissue establishments
  • Medicinal gasses
  • Euphoriant substances
  • Radiopharmaceuticals
  • Drugs affecting the ability to drive
• Product information
  • Medicintjek
  • Summaries of product characteristics
  • Package leaflet
  • Lists with information about medicinal products
• Legislation
  • The Danish Medicines Act
  • The Danish Pharmacy Act
  • The Danish Health Act
  • Pharmacovigilance legislation
  • Guidelines on advertising of medicinal products
  • Fees for authorisation and application
  • Doctors, dentists and proprietary pharmacists associated with a pharmaceutical company
    • Doctors and dentists
    • Companies' notification
  • Report suspected illegal activities with medicines
• About us
  • Mission, vision and values
  • Organisation
  • Committees and councils
  • Networks and task forces
  • The Medicine Profile – citizens' medication overview
  • Annual accounts and annual reports
  • Performance contracts
  • About DKMAnet
    • DKMAnet - questions and answers
  • Our websites
• Contact us
  • Phone book
  • Public Health Medical Officers in Denmark
  • National Institute of Radiation Protection
  • Press contact
  • EAN number, CVR number and bank details
  • Request access to documents
• Cookies
• Themes
• Publications
  • Decisions and practices
• Questions and answers
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