X
This page contains elements that are not optimised for mobile viewing. Click the link below to view the page in desktop mode.
Desktop mode
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 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
Error
This page is not available in English
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
...
Click here to see the Danish page 'Væsentlig opdatering af spørgsmål og svar om reference-dokumentet (RSI) ved kliniske forsøg'
Go to English frontpage
