Report adverse reactions of cannabis products
Healthcare professionals can report adverse reactions to medicinal cannabis (cannabis products) by using our e-form.
Please read the text below if you want to report an adverse reaction. Then click the link at the bottom of the page to access the reporting form.
We use the details you provide to build a clear picture of the adverse reaction you report. You must fill in the fields marked with a red star in the e-form, but it is of great help to us, if you fill in as many fields as possible.
It takes about ten minutes to fill in the e-form. If you have questions along the way, please call us on +45 4488 9595.
What to include in an adverse reaction report
When you report a suspected adverse reaction to the Danish Medicines Agency, it is important to include at least the following details:
- Identification of the suspected cannabis product.
- Indication and dose.
- A description of the suspected adverse reaction.
- One or more details about the affected patient: date of birth, civil registration number (CPR no.), gender, age or initials.
- Identification of the reporter.
A report submitted by a doctor should as far as possible contain information about the patient’s civil registration number (CPR no.), method of administration of the cannabis product, and the batch number of the cannabis intermediate product manufacturer.
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 adverse 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 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:
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 95
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: firstname.lastname@example.org
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 adverse reactions of cannabis products in our database of adverse reactions, and we use data about adverse reactions to investigate if there are new or changed product risks.
- The adverse reaction 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:
- Basic information such as name, title and workplace.
Recipients or categories of recipients
We disclose or transfer your personal data to the following recipients:
- The Danish Medicines Agency's database of adverse reactions 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.