Licensing and supervision
Brexit
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
Marketing authorisation
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
Parallel import and parallel trade
Deregistration
Parallel distribution
Naming of medicines
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
Order books
Completion of delayed cases in the licensing area
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
Authorisation procedures
Company authorisations and registrations
Supervision and inspection
Clinical trials
How to evaluate evidence of the efficacy of medicines
Evaluation of reviews
Report suspected illegal activities
Falsified medicines
Compassionate use
Medicine or not
Export certificates
Fees
Name/address changes
Relationships
Financial support
Medicinal Products Committee
Publications
Side effects and product information
Side effects of medicines
Additional monitoring
News on pharmacovigilance
Biological and biosimilar medicinal products
Safety updates
Post Authorisation Safety Study
Direct Healthcare Professional Communication
Adverse events
Drug interaction
Pharmacovigilance Council
Find medicines
Publications
Reimbursement and prices
General reimbursement
Individual reimbursement
Calculate reimbursement
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
Pharmacies and sale of medicines
Pharmacies
Sale outside pharmacies
Over-the-counter medicines
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
Report suspected illegal sale of medicines
Prescriptions from another country
Publications
Medical devices
Incident reporting
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
Development of medical devices
Regulatory advice for medical device companies
CE marking
Notified bodies
Registration and marketing
Clinical investigations
Performance studies of in vitro diagnostic medical devices (IVDs)
Certificates of Free Sale
Legislation and guidance
Publications
Special product areas
Veterinary medicines
Natural medicinal products and vitamin and mineral products
Euphoriant substances
Medical gases
Radiopharmaceuticals
Medicines affecting the ability to drive
Medicinal cannabis
Regulation of innovative medicinal products including ATMP
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
Campaigns
Copyright
Cookies
Publications
Sitemap
News
Subscribe to news
Edit subscription
Unsubscribe
News categories
Themes
Our newsletter DKMA Update
RSS Feed
Publications
Order publications
2024
2023
2022
2020
2019
2018
2017
2016
2015
2014
2013
2012
2011
2010
2009
2008
2007
2006
Go to main content
News
About us
Contact us
Publications
Cookies
Licensing and supervision
Licensing and supervision
Brexit
Licensing of medicines
Authorisation procedures
Company authorisations and registrations
Supervision and inspection
Clinical trials
How to evaluate evidence of the efficacy of medicines
Evaluation of reviews
Report suspected illegal activities
Falsified medicines
Compassionate use
Medicine or not
Export certificates
Fees
Name/address changes
Relationships
Financial support
Medicinal Products Committee
Publications
Side effects and product information
Side effects and product information
Side effects of medicines
Additional monitoring
News on pharmacovigilance
Biological and biosimilar medicinal products
Safety updates
Post Authorisation Safety Study
Direct Healthcare Professional Communication
Adverse events
Drug interaction
Pharmacovigilance Council
Find medicines
Publications
Reimbursement and prices
Reimbursement and prices
General reimbursement
Individual reimbursement
Calculate reimbursement
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
Pharmacies and sale of medicines
Pharmacies and sale of medicines
Pharmacies
Sale outside pharmacies
Over-the-counter medicines
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
Report suspected illegal sale of medicines
Prescriptions from another country
Publications
Medical devices
Medical devices
Incident reporting
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
Development of medical devices
Regulatory advice for medical device companies
CE marking
Notified bodies
Registration and marketing
Clinical investigations
Performance studies of in vitro diagnostic medical devices (IVDs)
Certificates of Free Sale
Legislation and guidance
Publications
Special product areas
Special product areas
Veterinary medicines
Natural medicinal products and vitamin and mineral products
Euphoriant substances
Medical gases
Radiopharmaceuticals
Medicines affecting the ability to drive
Medicinal cannabis
Regulation of innovative medicinal products including ATMP
Licensing and supervision
/
Licensing of medicines
/
Case statistics and order books
/
Number of cases
/
Den decentrale anerkendelsesprocedure 2023
Licensing and supervision
You must accept marketing cookies to share the page by mail
Update consent
Share by mail
Your email:
Recipient's email:
Verify you are a human
...
