Reporting of adverse reactions to medicinal cannabis – guidance for healthcare professionals
Healthcare professionals may report suspected adverse reactions to medicinal cannabis (cannabis end-products) using our e-form.
Please read the text below and then click on the link to the e-form at the bottom of the page to report a suspected adverse reaction.
Getting started
We use the details you provide to build up a clear picture of the suspected adverse reaction you are reporting. Please complete as many fields as possible so that the information may be included in our pharmacovigilance activities.
If you have questions while completing the e-form, please call us on +45 4488 9595.
Mandatory information in adverse reaction reports
When you report a suspected adverse reaction to the Danish Medicines Agency, you should provide at least the following details:
- Identification of the suspected cannabis end-product
- Indication and dose
- A description of the suspected adverse reaction
- Detail(s) about the affected patient: date of birth, civil registration number, gender, age or initials
- Identification of reporter
A report submitted by a doctor should, to the extent possible, include the patient’s civil registration number, the method of administration of the cannabis end-product and the batch number of the cannabis intermediate product.
In some cases, we may need to obtain additional information to enable our assessment of the report. If so, we will contact you to obtain the necessary information.
Information obligation when collecting personal data
When you make a report about a suspected adverse reaction, we receive personal data about you, which we register and process.
Article 13 of the General Data Protection Regulation obliges us to inform you about a number of details:
We are the data controller - how to contact us
The Danish Medicines Agency is the data controller when processing the personal data, we have received about you. Please find our contact details below.
Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Denmark
Company registration number (CVR): 37052485
Telephone: +45 4488 9595
Email: Send an email
Contact details of the data protection officer
If you have questions about our processing of your data or wish to exercise your rights, please contact us. Use one of the following contact options:
Email: Send an email. If your inquiry contains sensitive or confidential information (e.g. personal health data and civil registration number, we advise you to always use secure communication. Address your inquiry “Data Protection”. Find out how to send secure email to the Danish Medicines Agency on this page.
Letter: The Danish Medicines Agency, Axel Heides Gade 1, 2300 Copenhagen S, Denmark, Attn. “Data protection”.
You may also contact the ministry-wide data protection officer (DPO): Helle Ginnerup-Nielsen at the Danish Ministry of the Interior and Health. Use one of the following contact options to contact the data protection officer:
Email: Send an email. If your inquiry contains sensitive or confidential information (e.g. personal health data and civil registration number, we advise you to always use secure communication. Address your inquiry “Data protection officer”. Find out how to send secure email to the Danish Ministry of the Interior and Health on the website of the Danish Ministry of the Interior and Health.
Letter: Danish Ministry of the Interior and Health, Slotsholmsgade 10-12, 1216 Copenhagen K, Denmark, Attn.: “Data protection officer”
Purposes and 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 to cannabis end-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 legal basis for our processing of your personal data is as follows:
Section 56 of the Danish Act on a Medicinal Cannabis Programme, section 5 and section 8 of the Danish Executive Order on Reporting of Adverse Reactions from Medicinal Cannabis and Processing of Adverse Reaction Reports, section 6(1), section 7(3) and section 11(1) of the Danish Data Protection Act, article 6(1)(e), article 9(2)(h) and (i) of the General Data Protection Regulation and section 32(1) of the Danish Executive Order on the Civil Registration System.
Categories of personal data
We process the following categories of personal data about you:
- Basic information;for example your name, title, place of work and possibly your contact details
- Personal health data if you are reporting a suspected adverse reaction that happened to you personally
The use of data processors
The Danish Medicines Agency engages data processors to carry out tasks on its behalf. We have entered into data processor agreements with our data processors. We monitor their compliance with the data processor agreements according to the rules in force.
Recipients or categories of recipients
We disclose your personal data to the following recipients:
The Danish Medicines Agency may disclose your data for research purposes, specifically scientific and statistical surveys of substantial public interest. This follows from section 10 of the Danish Data Protection Act.
If we have an obligation to do so, the Danish Medicines Agency may disclose your personal data to the Danish National Archives for archiving. This follows from section 14 of the Danish Data Protection Act and section 12 of the Danish Archives Act.
Storing of your personal data
At present, we cannot say for how long we will be storing your personal data. We will determine the storage period based on the following principle:
Your data will only be stored for as long as it is necessary to monitor the safety of medicinal cannabis, taking into account that it may be relevant to identify you for follow-up to ensure patient safety.
Your rights
The General Data Protection Regulation gives you several rights as regards 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 such right applies, the data may, with the exception of storage, only be processed by us with your consent, or for the establishment, exercise or defence of legal claims, or to protect 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. Contact details for the Danish Data Protection Agency can be found at www.datatilsynet.dk.
E-form
Link to e-form for reporting adverse reactions
Information obligation when collecting personal data
Under Article 13 of the General Data Protection Regulation, the Danish Medicines Agency has an obligation to inform you about its processing of your report containing personal data about you and your rights. The guidance provided above applies in this respect.
Please disregard the guidance provided in the introduction to the reporting e-form, as the guidance concerns the processing of personal data in adverse reaction reports for authorised medicinal products, and, among other things, the legal basis is not the same as that applying to the processing of personal data in reports of suspected adverse reactions to medicinal cannabis covered by the medicinal cannabis programme.
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