Report a side effect of cannabis products
Report side effects of medicinal cannabis
If you use medicinal cannabis or are close to someone who do, you can report side effects from such products by using our Danish e-form.
Please read the text below and then click on the link to the form at the bottom of the page to report a side effect you suspect is caused by medicinal cannabis.
You will find it helpful to have the pack of medicinal cannabis ready to fill in the details about the product.
You can find the form here (in Danish only)
It takes about ten minutes to complete the e-form.
If you have questions along the way or cannot use the e-form to make a report, please call us on +45 4488 9595.
Tell your doctor if a side effect has happened to you, a relative or someone close to you
You should always tell your doctor if you, a relative or someone close to you experience side effects. Your doctor can assess if the side effect means you should receive a different treatment.
What is a side effect?
A side effect is an unwanted effect caused by medicinal cannabis.
A side effect could be:
No systematic studies have been made of the type of side effects caused by medicinal cannabis or how common they are.
When you make a report about a suspected side effect, we receive personal data about you, which we register and process.
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
CVR no.: 37052485
Telephone: +45 44 88 95 95E-Mail: Send an email
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:
- Email: Send an email
Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Att. ”Data Protection Officer"
The purposes and the legal basis of the processing of your personal data
We process your personal data for the following purposes:
- The Danish Medicines Agency records all suspected side effects to cannabis products in our database of side effects, and we use data about side effects to investigate if there are new or changed product risks.
- The side effect data will be used for our monitoring and evaluation of the four-year medicinal cannabis pilot programme.
The legal basis for our processing of your personal data follows from:
Part VIII of Danish Act no. 1668 of 26 December 2017 on a Medicinal Cannabis Pilot Programme, and Danish Executive Order no. 1732 of 26 December 2017 on the Reporting of Adverse Reactions from Medicinal Cannabis and Processing of Adverse Reaction Reports.
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 of categories of recipients
We disclose or transfer your personal data to the following recipients:
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
At present, we cannot say for how long we will be storing your personal data, but it will definitely be stored throughout the duration of the four-year period of the medicinal cannabis pilot programme (1 January 2018 – 31 December 2021). When it is to be decided for how long your data will be stored after the four-year period, the following will be emphasised:
– that your data are stored for as long as it is relevant for reasons of patient safety to identify you to pose follow-up questions. After that, the patient details will be anonymised.
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.