Report adverse reactions of cannabis end-products

Healthcare professionals can report adverse reactions from medicinal cannabis (cannabis-end products) by using our e-form.

Please read the text below and then click on the link to the form at the bottom of the page to report an adverse reaction.

Getting started

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 your ADR 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 end-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 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 end-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 to be provided when personal data are collected

When you make a report about a suspected adverse reaction, we receive personal information about you that 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 certain information:

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We are the data controller – how to contact us

As data controller, the Danish Medicines Agency processes the personal information we receive from you. Please find our contact details below.

Danish Medicines Agency

Axel Heides Gade 1
2300 Copenhagen S
Denmark
CVR (company registration) number: 37052485
Telephone: +45 44 88 95 95
Mail: Send an e-mail

Contact details of the data protection officer

If you have questions about the processing of your data, please contact our data protection officer.

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

E-mail: Send an e-mail

Letter:

Danish Medicines Agency

Axel Heides Gade 1
2300 Copenhagen S
Denmark
Attn.: ”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 end-products in our database of adverse reactions, and we use ADR data to investigate if there are new or changed product risks.
• The ADR 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 data, such as name, title and workplace.
• Personal medical data when reporting a suspected adverse reaction that you have experienced yourself

Recipients or categories of recipients.

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

• The Danish Medicines Agency's database of side effects, 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 data processor, MHRA, used by the Danish Medicines Agency is based in the UK. On 28 June 2021, the European Commission adopted a decision, acknowledging that the UK has an adequate level of data protection and thus is a secure third country pursuant to article 45 of the General Data Protection Regulation.

MHRA, uses a subcontractor, Accenture India, in India.  The Danish Data Protection Agency has authorised the specific transfer of data to a third country by 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 be retained in the four-year period of the medicinal cannabis pilot programme (1 January 2018 – 31 December 2021). In determining for how long your data should be stored after this period, we will pay special attention to the following:

Your data is retained only for the period necessary to identify and contact you if we need more information to safeguard patient safety. After that, patient details will be anonymised.

Your rights

The General Data Protection Regulation gives you a number of rights to control how we process your personal data. 

You can use these rights by contacting 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 inaccurate information about you corrected.

Right to erasure

In exceptional cases, you have the right to have information held about you erased before the time we would otherwise do so.

Right to restriction of processing

In certain cases, you have the right to restrict the processing of data held about you. If processing has been restricted, we are – with the exception of storage – only allowed to process these data 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.

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.

Form

Link to e-form for reporting side effects