Report a side effect from human medicines or vaccines - for medicine users and relatives (e-form)

Updated 25 September 2018

Medicine users and relatives can report side effects to human medicines (including vaccines) by using the Danish e-form below.

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

Getting started

Before you fill in the e-form, you should know a few things.

We use the details you provide to build a clear picture of the side effect you or someone else has experienced. You must fill in all the fields marked with a red star in order to send the e-form, but it is of great help to us, if you fill in all fields as precisely as possible.

It may be a good idea to have the medicine pack ready as you will need to 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 along the way, please call us on +45 4488 9595.

In some cases, we may need to obtain additional information on the report. If so, we will contact you to obtain the necessary information.

Information we must provide when personal data are collected

When you make a report about a suspected side effect, we receive personal data about you, which we register and process. 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: 

Expand all

We are the data controller - how to contact us

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

Contact details of the Data Protection Officer

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:

By letter:

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

The purpose and the legal basis of the processing of your personal data

We process your personal data for the following purposes:

  • The Danish Medicines Agency monitors the safety of medicines.
  • The report that the Danish Medicines Agency receives is registered in our database of side effects and is part of our work with the monitoring of the safety of medicines.
  • The Danish Medicines Agency sends the report to the European database of side effects (the EudraVigilance database) of the European Medicines Agency (EMA). The EMA does not receive information about your name, CPR (civil registration) number or contact details.
  • In order to monitor the safety of medicines, the pharmaceutical company manufacturing the medicine, the EMA, the drug regulatory authorities in EU/EEA countries and 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 EU drug regulatory authorities to continuously assess if new information on side effects implies that changes should be made to the medicine's package leaflet, etc. The pharmaceutical company also has an obligation to assess the medicine's safety continuously, and in this connection, they use all the information about side effects 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.

Categories of personal data

We process the following categories of personal data about you:

Health data and basic information, e.g. name, initials, CPR (civil registration) number.

Recipients or categories of recipients

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

  • The Danish Medicines Agency sends the report to the European database of side effects (the EudraVigilance database) of the European Medicines Agency (EMA). The EMA does not receive information about your name, CPR (civil registration) number or contact details.
  • In order to monitor the safety of medicines, the pharmaceutical company manufacturing the medicine, the EMA, the drug regulatory authorities in EU/EEA countries and 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's database of side effects 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.

Transfer to recipients in third countries, including international organisations

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.

Storing of your personal data

Reports of suspected side effects are part of the Danish Medicines Agency's monitoring of the safety of specific medicines. Monitoring (pharmacovigilance) data must, according to article 16, second paragraph, of the European Commission's Implementing Regulation on the performance of pharmacovigilance activities, be stored for as long as the medicine is authorised and for at least 10 years after the marketing authorisation has expired.

At the Danish Medicines Agency, we anonymise the individual report in our database of side effects 25 years after registration at the latest. The reason is that it will not be relevant to follow-up on the individual medicine user after that. 

Your rights

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.

Lodging a complaint with the Danish Data Protection Agency

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).

Contact your doctor

Should you need treatment for side effects, please contact your doctor.

If you think you have suffered an actual injury from side effects, you can report the damage and read more at the website of the Danish Patient Compensation Association.

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.