Report a side effect from human medicines or vaccines - for medicine users and relatives (e-form)
The forms for reporting side effects are only available in Danish. You can ask a friend who is familiar with the Danish language to help you fill it in. Guidelines are given in English below.
Medicine users and relatives can report side effects from human medicines (including vaccines) by using the Danish e-form below.
Please read the text below before you report a side effect to us.
Before you fill in the e-form describing a side effect you have experienced from treatment with medicine, there are a few things you should know.
We use the details you provide to build a clear picture of the side effect you have experienced. You must fill in the fields marked with a red star to be able to send the e-form, but it is of great help to us if you fill in all the fields as precisely as possible.
It may be a good idea to have the medicine pack ready when you enter information about the medicine and the manufacturing company.
It takes about ten minutes to fill in the e-form. If you have any questions, please call us on +45 44 88 95 95.
What happens after you have reported an adverse reaction?
We register your report in our database of side effects. We send it to the WHO and to the manufacturing company. If your report is classified as serious, we will also send it to the European Medicines Agency (EMA). The information is anonymised so that the recipients cannot see your name and address.
Our work with adverse reaction reports
Adverse reaction reports from citizens are an important part of our monitoring of the safety of the medicines we use in Denmark.
Together with the EMA and the other regulatory authorities in the EU we regularly assess whether new information about adverse reactions means that the medicine’s package leaflet should be changed. The pharmaceutical company is also obliged to assess the safety of the medicine continuously, and for that purpose they use all adverse reaction reports received from all parts of the world.
All known adverse reactions from a medicinal product must appear from the package leaflet. You can find the package leaflets of all medicinal products authorised in Denmark at www.indlaegsseddel.dk or www.produktresume.dk
Since your report contains your personal data, which we register and process at the Danish Medicines Agency, we inform you that you have the following rights under the Danish Act on Processing of Personal Data:
- You have a right to know that we have collected data about you and saved in our database of adverse drug reactions.
- You have the right to be informed of the personal data that we are processing about you, the purpose of such processing, the classes of recipients to whom they are disclosed, and the source of those data.
- You have the right to object to our processing of your personal data.
- You have the right to ask us to correct or delete information if you believe that the information is inaccurate or misleading.
More information about your rights under the Danish Act on Processing of Personal Data is available in Danish at www.retsinformation.dk
We may contact you if we have questions as to our processing of the reported adverse reaction. You are not obliged to answer our questions.
If you require treatment of the adverse reactions, please consult your doctor.
If you believe that you suffer from injury caused by the adverse reactions, you can report it to the Danish Patient Compensation Association. Read more at www.patienterstatningen.dk