Report an adverse drug reaction from human medicines - for healthcare professionals (e-form)

Updated 19 February 2021

Healthcare professionals can report a suspected adverse reaction (ADR) to medicines by using the Danish e-form below.

Please read the text below if you want to report a suspected ADR. Then click the link at the bottom of the page to access the reporting form.

Getting started

We use the details you provide to build a clear picture of the ADR you have reported. Thus, it will be very helpful to us, if you fill in as many fields as possible.

Contents of an ADR report

Before you submit an ADR report to the Danish Medicines Agency it is important that it contains information about the following:

  • Identification of the suspected medicinal product or active substance. To the extent possible, reports submitted by doctors, dentists, treatment pharmacists and midwifes should contain the product’s name and batch number when the report deals with a biological product appearing from the list of selected biological medicinal products published on the Danish Medicines Agency’s website.
  • A description of the suspected ADR.
  • One or more details on the concerned patient: date of birth, civil registration number (CPR), gender, age or initials. ADR reports submitted by doctors, dentists, treatment pharmacists or midwifes must contain the patient's civil registration number (CPR).
  • Identification of the reporter.

Please note that any prefixed zeroes should not be entered if you fill in the provider ID. The field is not mandatory.

Information we must provide when personal data are collected

When you submit an ADR report about a suspected adverse drug reaction, we receive personal data about you, which we register and process. We register your basic information, such as name, workplace and contact details in case we have follow-up questions to your ADR report.

According to article 13 of the General Data Protection Regulation, we must provide you with a number of details.  The details we must give you are:

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