Sitemap
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Licensing and supervision
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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
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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
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SPCs, package leaflets and labelling
- Exemption from the requirements for labelling, implementation deadlines, package leaflets etc. for medicinal products
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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
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Upload package leaflets to DKMAnet
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Marketing authorisation
- Call to industry to Apply for Marketing Authorization for Selected Medicines
- Marketing authorisations without Danish product information
- National Scientific Advice
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Application for marketing authorisation
- Allocation of time slots (DCP)
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Updating of documentation before start-up of MRP/RUP
- Procedure for national applications
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Sunset clause
- Paediatric data
- Guidelines for submission and technical validation of applications
- Generic medicines (generics)
- Receipt, acceptance and approval letters
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Renewal of marketing authorisation
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Safety features on medicinal products
- Changing the legal status of a human medicinal product
- Patented indications and substitution
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Variations
- Obligations regarding updates of Active Substance Master Files (ASMF/DMF)
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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
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Questions and answers on variations after 1 January 2010
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Parallel import and parallel trade
- Deregistration
- Parallel distribution
- Naming of medicines
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Case statistics and order books
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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
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Assessment times
- Order books
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Completion of delayed cases in the licensing area
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Number of cases
- Lists of authorised and deregistered medicines
- Medicines authorised with a summary of the risk management plan
- Medicinal products with educational material (EDUMAT)
- Medicines under additional monitoring
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Authorisation procedures
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Company authorisations and registrations
- Organisation data from OMS in EudraGMDP
- Manufacture of medicines and intermediates
- Wholesale distribution
- Manufacture, importation and distribution of API
- Euphoriant substances
- Medicinal cannabis pilot programme
- Retail of medicinal products
- Medical gases
- Retail of medicinal products for livestock
- Non-clinical trials (GLP)
- Radiopharmaceuticals
- Wholesale distribution of certain substances
- Medicine chests for lifeboats and liferafts
- Brokering of medicines
- Supervision and inspection
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Clinical trials
- What is a clinical trial?
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Questions and answers
- Regulation for Clinical Trials
- Substantial modifications
- Assessment times
- GMP and Quality of IMP
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Non-clinical regulatory advice
- Safety reporting during clinical medicinal 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
- End of trials with medicinal products and reporting of results
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Trials in animals
- GCP inspection
- Publications
- How to evaluate evidence of the efficacy of medicines
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Evaluation of reviews
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Report suspected illegal activities
- Falsified medicines
- Compassionate use
- Medicine or not
- Export certificates
- Fees
- Name/address changes
- Relationships
- Financial support
- Medicinal Products Committee
- Publications
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Brexit
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Side effects and product information
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Side effects of medicines
- Report a side effect
- Registration and monitoring
- EudraVigilance
- Companies' reporting of side effects
- Interactive Adverse Drug Reaction overviews
- Stricter reporting requirements
- Compensation for pharmaceutical injuries
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Pharmacovigilance and the EU cooperation
- Childhood vaccines
- Pharmacovigilance and inspections
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Network for the Prevention of Medication Errors
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Danish Pharmacovigilance Update
- Publications
- Additional monitoring
- News on pharmacovigilance
- Biological and biosimilar medicinal products
- Safety updates
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Post Authorisation Safety Study
- Direct Healthcare Professional Communication
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Adverse events
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Drug interaction
- Pharmacovigilance Council
- Find medicines
- Publications
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Side effects of medicines
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Reimbursement and prices
- General reimbursement
- Individual reimbursement
- Calculate reimbursement
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Medicines bought in another EU/EEA country
- Reimbursement Committee
- The EU HTA regulation
- Prices of medicines
- Product numbers
- Central Reimbursement Register
- Reimbursable nutritional products
- Publications
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Pharmacies and sale of medicines
- Pharmacies
- Sale outside pharmacies
- Over-the-counter medicines
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Substitution
- Medicines imported from abroad
- Buying and selling medicines online
- Sale of medicines or food supplements online
- Doctors buying medicines for use in their own practices
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Report suspected illegal sale of medicines
- Prescriptions from another country
- Publications
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Medical devices
- New regulations
- COVID-19 antigen test for self-test
- Advice to consumers on buying face masks
- New Tech – new technological possibilities and medical devices
- Patient safety and safe medical devices
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Development of medical devices
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Regulatory advice for medical device companies
- CE marking
- Incident reporting
- Notified bodies
- Registration and marketing
- Clinical investigations
- Performance studies of in vitro diagnostic medical devices (IVDs)
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Certificates of Free Sale
- Legislation and guidance
- Publications
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Special product areas
- Veterinary medicines
- Natural medicinal products and vitamin and mineral products
- Euphoriant substances
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Medical gases
- Radiopharmaceuticals
- Medicines affecting the ability to drive
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Medicinal cannabis
- Questions and answers on medicinal cannabis
- Medicinal cannabis pilot programme
- Development authorisation
- Fees
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Regulation of innovative medicinal products including ATMP
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About us
- Mission, vision and strategy
- Contact
- Organisation
- Whistleblowing scheme of the Danish Medicines Agency
- The Danish Medicines Agency funding
- Management of conflicts of interest
- Transparency in the Danish Medicines Agency
- Data protection policy
- Targets and tasks
- International collaboration
- Jobs
- Digital services
- About this site
- Social media
- Design
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Campaigns
- Copyright
- Cookies
- Publications
- Sitemap
- Publications