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

Updated 25 September 2018

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 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 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.

If you have any questions along the way, please contact us on +45 4488 9595.

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:

The Danish Medicines Agency is the data controller in respect of the processing of the personal data we have received from you. Please find our contact details below.

Danish Medicines Agency

Axel Heides Gade 1
2300 Copenhagen S
Denmark

CVR no.: 37052485

Telephone: +45 44 88 95 95

Email: dkma@dkma.dk

If you have questions about our processing of your data, we advise you to contact our data protection officer.

Our data protection officer, Troels Mogensen, can be contacted in the following ways:

The Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Denmark
Att. ”Data Protection Officer"

We process your personal data for the following purposes:

  • The Danish Medicines Agency monitors the safety of medicines.
  • The ADR report that the Danish Medicines Agency receives is registered in our Danish ADR database and is part of our work with the monitoring of the safety of medicines.
  • The Danish Medicines Agency forwards the ADR report to the European database of adverse drug reaction reports (the EudraVigilance database) of the European Medicines Agency (EMA).
  • In order to monitor the safety of medicines, the pharmaceutical company manufacturing the medicine, the EMA, the national competent authorities in the EU-EEA countries as well as the European Commission have access to the data in the EudraVigilance database. The EMA also sends information from the EudraVigilance database to the WHO.
  • The Danish Medicines Agency collaborates with the EMA and the other national competent authorities. We continually assess if new information on ADRs should result in a change to e.g. the medicine's package leaflet. The pharmaceutical company also has an obligation to assess the medicine's safety continuously, and in this connection, they use all the information on ADRs that they receive from all over the world.

The legal basis for our processing of your personal data follows from:

Section 56(1) and (2) of the Danish Medicines Act, the Danish Executive Order on Monitoring of Adverse Reactions, Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, the European Commission's Implementing Regulation on the performance of pharmacovigilance activities.

We process the following categories of personal data about you:

  • Basic information, e.g. name, title, workplace.

We disclose or transfer your personal data to the following recipients:

  • The Danish Medicines Agency forwards the ADR report to the European database of adverse drug reaction reports (the EudraVigilance database) of the European Medicines Agency (EMA).
  • In order to monitor the safety of medicines, the pharmaceutical company manufacturing the medicine, the EMA, the national competent authorities in the EU-EEA countries as well as the European Commission have access to the data in the EudraVigilance database. The EMA also sends information from the EudraVigilance database to the WHO.
  • The Danish ADR database is a database established and operated by the British Medicines and Healthcare products Regulatory Agency (MHRA). The Danish Medicines Agency thus uses the MHRA as a data processor. 

Your personal data is transferred to recipients outside the EU and the EEA.

The Danish Medicines Agency's data processor, MHRA, uses a subcontractor, Accenture India, in India.

The Danish Data Protection Agency has authorised the specific transfer of data to a third country in its authorisation dated 8 October 2010, cf. article 46(5) of the General Data Protection Regulation. You can request a copy of the authorisation granted by the Danish Data Protection Agency by contacting us.

Reports of suspected ADRs are part of the Danish Medicines Agency's monitoring of the safety of specific medicines. Pharmacovigilance data must according to EU legislation be stored for as long as the medicine is authorised and for at least 10 years after the marketing authorisation has expired.

The General Data Protection Regulation gives you a number of rights in respect of our processing of your personal data. 

If you want to make use of your rights, you need to contact us.

Right to see your data (right of access)

You have the right to access the information we process about you as well as other information.

Right to rectification (correction)

You have the right to have incorrect information about you corrected.

Right to erasure

In exceptional cases, you have the right to have information about you erased before the time we would generally erase the information.

Right to restriction of processing

In certain cases, you have the right to have the processing of your data restricted. If you do have the right to restriction of processing, then we are only allowed to process your data, with the exception of storage, with your consent or for the establishment, exercise or defence of legal claims or for the protection of the rights of another person or for reasons of important public interest.

Right to object

In certain cases, you have the right to object to our otherwise legal processing of your personal data.

You can read more about your rights in the Danish Data Protection Agency's guidelines on the rights of data subjects. The guidelines are available in Danish at the website of the Danish Data Protection Agency: www.datatilsynet.dk.

You have the right to lodge a complaint with the Danish Data Protection Agency if you are displeased with the way in which we process your personal data. The contact details of the Danish Data Protection Agency are available at www.datatilsynet.dk (in Danish only)

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