Annual reporting
Companies' reporting obligation:
Companies have a reporting obligation with respect to the healthcare professionals and specialists with whom they have had a professional relationship or to whom they have provided financial support in the previous calendar year.
Reports must be digitally submitted once a year no later than 31 January.
Reports must be submitted, listing the healthcare professionals who have had a relationship with the companies and healthcare professionals and specialists to whom the companies have provided financial support.
Information to the affected healthcare professionals and specialists
At the time of submitting reports to the Danish Medicines Agency, companies must inform the healthcare professionals and specialists concerned of the information submitted.
The Danish Medicines Agency recommends doing so before submitting the reports to the Agency so that the companies have time to update their reports with any changes before submitting them to the Agency by 31 January.
Reporting templates
Reports must be made in separate Excel sheets.
Template for reporting of relationship
Template for reporting of financial support
Report submission form
Companies with a Danish business registration number (CVR) must submit the template using this form requiring a MitID Business login.
Companies without a Danish business registration number must submit the template using this form which does not require a MitID Business login.
FAQ
May we submit a combined report with affiliated companies?
Only these companies are obliged to submit a report about healthcare professionals who have had a relationship with the company. Each company only needs to submit a report about the persons who have had a relationship with the company.
A company, which is not comprised by the above definitions, will not be covered by the rules on relationships just because another company of the group is covered by the rules.
Is it safe to include personal data, such as civil registration numbers of healthcare professionals, in the reports?
Company reports must be submitted by way of a form as it enables us to ensure that the report is actually submitted by the company and that data is sent in a secure way.
Delegated to third-party companies - do we have to submit a report?
These companies are covered by the reporting obligation and the duty to inform.
The rules also apply if one of these companies delegates a task to a third party, for example a contract organisation or consultancy firm. In such cases, there is a relationship with the pharmaceutical or medical device company or the store specialised in the sale of medical device that delegated the task.
Consequently, the company that delegated the task must submit reports of proprietary pharmacists, prescribing pharmacists, midwives, doctors, nurses and dentists who have carried out work for the company via a third party.
We have collaborated with the same healthcare professional several times. Do we have to enter a start date and end date every time we have collaborated with the healthcare professional?
Reporting on healthcare professionals or specialists only has to be submitted once covering one period for the year in question. If a healthcare professional or specialist has had several relationships with your company or been granted financial support for multiple activities within the reporting year in question, please state the start date of the first relationship and the end date of the last relationship in that year. In terms of financial support, you must enter the end date of the last activity for which the healthcare professional or specialist has received financial support in the reporting year.