FAQ about companies’ reporting

You can submit your reports by using this e-form (in Danish) on our website.

Before you log in to the e-form, please download, save and fill in the Reporting template (in Danish). To submit your report to the Danish Medicines Agency, you log in to the e-form, attach the filled in Excel sheet and send the report.

Please check that the email address is correct. We will send a confirmation, including any questions, by email to the email address you have stated.

Please use this template (in Danish). You can also find the template on this page.

You should save the template before you fill it in.

When you fill in the template, please do not change or add columns, and do not change headings and cell formats. Such changes may affect the validation of the Excel sheet when you attach it to the e-form Report a relationship with healthcare professionals (e-form) (in Danish).

The reporting obligation applies to:

• Companies authorised under section 7(1) (marketing authorisation) or section 39(1) (company authorisation) of the Danish Medicines Act. Public hospitals and AMGROS, the pharmaceutical procurement service for the five regional authorities in Denmark, are not covered by the rules.

• The rules apply to manufacturers that market medical devices in classes IIa, IIb or III, in vitro diagnostic medical devices or active implantable medical devices, representatives of manufacturers of this type of products as well as importers and distributors of this type of products that are established in Denmark.

• The rules apply to stores established in Denmark and specialised in the sale of medical devices in classes IIa, IIb or III, in vitro diagnostic medical devices or active implantable medical devices, and representatives of such stores. A store is a specialised distributor if medical devices account for more than 50% of the store’s product range and turnover.

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.

A Danish unit of a foreign company can ease the work of the foreign company

If a company has a Danish unit (e.g. a foreign parent company with a Danish subsidiary), the Danish unit can ease the work of the foreign company by completing the required information and sending the required information to the foreign company, which can then submit the completed information to us.

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, doctors, nurses, prescribing pharmacists (only medical device companies) and dentists who have carried out work for the company via a third party.

Simultaneously with the reporting to the Danish Medicines Agency, the company must inform the relevant proprietary pharmacists, doctors, nurses, prescribing pharmacists and dentists of the contents of the report (the information about the person reported to the Danish Medicines Agency).

You can read more about companies’ duty to inform under sections 2 (when establishing a relationship) and 3 (when reporting to the Danish Medicines Agency).

Reporting must be made once a year no later than 31 January.

If a proprietary pharmacist, doctor, nurse, dentist or prescribing pharmacist carries out a professional task for a pharmaceutical company, medical device company or store specialised in the sale of medical device, this is considered a relationship. The type of business determines which healthcare professionals the company needs to report:

• Pharmaceutical companies must report information on doctors, dentists, proprietary pharmacists and prescribing pharmacist who have had a relationship with the company concerned in the past calendar year.

• Medical device companies must report information on doctors, nurses, dentists and proprietary pharmacists who have had a relationship with the company concerned in the past calendar year.

• Reporting by stores specialised in the sale of medical devices must include information on doctors who have had a relationship with the store concerned in the past calendar year.

Example:

Question: Should a company report nurses who give presentations to a pharmaceutical company?

Answer: No, pharmaceutical companies only need to report doctors, dentists, prescribing pharmacists and proprietary pharmacists that they have had a relationship with.  Other professional groups, such as nurses, psychologists, bioanalysts, radiographers etc. should not be reported.

Note! Please note that the rules on companies’ reporting obligation only apply to doctors, nurses and dentists undertaking clinical duties in Denmark as well as proprietary pharmacists.

Nurses should only be reported by medical device companies.

Example:

Question: We are both a pharmaceutical company and a medical device company. We conduct clinical trials in which nurses participate. Do we have to report the nurses?

Answer: No, you do not have to report nurses if the specific relationship with your company only concerns medicinal products (see the Danish executive order no. 693 of 3 July 2019 on healthcare professionals’ relationships with pharmaceutical and medical device companies and stores specialised in the sale of medical devices) (in Danish).

Yes, this is considered a relationship whether or not the healthcare professional receives payment for the specialist services provided. If a proprietary pharmacist, doctor, nurse (only medical device companies) or dentist carries out work for a pharmaceutical or medical device company, it will be considered a relationship. The company must report the relationship to the Danish Medicines Agency whether or not any payment is made.

The same applies to stores specialised in the sale of medical devices that have relationships with doctors.

No, if your company pays the expenses of a specialist or healthcare professional participating in professionally relevant activities abroad (congress, symposium, course, conference, supplementary training etc.), it should not be reported to the Danish Medicines Agency.

Companies only have a duty to inform when they accept to give financial support to: bioanalysts, veterinarians, pharmacists, pharmacy technicians, midwives, clinical dieticians, doctors, radiographers, nurses, social and healthcare assistants, dentists, veterinary nurses and students within these professions. Moreover, certain specialists are covered by the rules, read more in section 2

Note that financial support and relationships are two different things regulated by two different sets of rules:

• Financial support means support given to a specialist or healthcare professional by a pharmaceutical or medical device company for the payment of any direct expenses (e.g. transportation, accommodation or registration fees) in connection with the person’s participation in for instance a course abroad.
  The specialist or healthcare professional does not carry out any work for the company but receives professional information and training abroad.

• If a proprietary pharmacist, doctor, nurse, prescribing pharmacist or dentist carries out a professional task, for example participation in an advisory board or presentation at a congress for a company, this is considered a relationship. This is the case regardless of whether the work is carried out in Denmark or abroad.

Relationships must be reported – whereas financial support should not be reported.
Read more about financial support

Generally, all relationships must be reported to the Danish Medicines Agency. This applies to single relationships as well as long-term relationships.

In relations to a clinical trial or a clinical investigation of medical devices, companies are obligated to report the doctors, nurses (in relations to a medical device company), dentists, prescribing pharmacists (in relations to a pharmaceutical company) and proprietary pharmacists who has the overall responsibility during the clinical trial. That means the primary investigator and others with similar responsibilities.

Subinvestigators and others with similar tasks, should not be reported, unless they receive payment for their work.

If you arrange (or co-arrange with the media, a patient association or other organisation or via an agency/consultancy firm) panel debates open to the public about general health issues and a proprietary pharmacist, doctor, nurse, prescribing pharmacist (only in relation to medical device companies) or dentist participates in the panel, this is considered a relationship that must be reported to the Danish Medicines Agency.

You also need to report the healthcare professional’s participation if the debate is arranged by the media, a patient association or other organisation or via an agency/consultancy firm, and your company supports the debate financially and funds from your company are used to make a payment to a proprietary pharmacist, doctor, nurse, prescribing pharmacist (only in relation to medical device companies) or dentist.

No, companies do not have to report relationships concerning ownership of securities (see the Danish executive order no. 693 of 3 July 2019 on healthcare professionals’ relationships with pharmaceutical and medical device companies and stores specialised in the sale of medical devices) (in Danish).

The Danish executive order no. 693 of 3 July 2019 on healthcare professionals’ relationships with pharmaceutical and medical device companies and stores specialised in the sale of medical devices (section 17(2)(ii) as amended by the Danish executive order no. 1685 of 16 December 2016 on an amendment of the executive order on healthcare professionals’ relationships with pharmaceutical and medical device companies and stores specialised in the sale of medical devices) stipulates that companies’ reporting must contain the following information about the healthcare professionals:

• full name
• workplace
• home address

• Health professionals' registration ID or civil registration number (CPR-nummer)

Consequently, we expect that companies ask the healthcare professionals to provide this information, including their home address.

Note that the columns Address, Postcode and City in the template (Excel) concern the healthcare professional’s home address, not the workplace.
In the column Workplace, it is sufficient to indicate the hospital or the name of the medical practice, e.g. Rigshospitalet. 
In the column Civil registration number, please state the health professionals' registration ID or civil registration number of the healthcare professional.

You only have to enter one period. If a healthcare professional has had several relationships with your company, please state the start date of the first relationship and the end date of the last relationship.

Companies submit reports to the Danish Medicines Agency via an e-form which is available on our website. By way of this e-form, we make sure that the report is actually submitted by the company and that data is sent in a secure way.

You have to use your employee digital signature (key file) to report a relationship with healthcare professionals.

If you experience problems when you log in to the e-form, it may be due to the following:

• you use an outdated browser (e.g. Internet Explorer 8). In that case, please try a later version or another browser (e.g. Google Chrome).
• the employee digital signature is not working. Make sure that you use the employee certificate (key file). Please contact NemID if you cannot log in to the e-form using the key file.

You can read more about NemID business and get an employee certificate (key file) via NemID erhverv

Please send the reporting by email to Send an email. Attach the filled in Excel sheet (without the civil registration numbers of healthcare professionals).

Please note that emails to the Danish Medicines Agency are not encrypted.

Reporting by foreign companies

Please send the filled in Excel sheet to Send an email as a protected file.

How to protect your file before sending it:

You can protect your Excel sheet when you save it: select "Save as" and then choose "General options" from the drop-down menu "Tools". Then write a password and select "OK" and reenter the password and click "OK".

If the validation is unsuccessful, an error message will explain which fields in the Excel sheet you need to correct. You should correct each field so that it has the right content or format. For example, empty fields may affect the validation.

Please note that the error message can be long if many fields in the Excel sheet are not filled in correctly.

Below you can find examples of problems that will lead to unsuccessful validation of the attached file:

Example – empty fields:

Postcode and City are mandatory fields. If these fields are empty, the validation fails.

If you do not have the relevant postcode, please enter ”0” and under City you can write ”not disclosed”.

Example – civil registration numbers:

The civil registration number field is mandatory and must show the civil registration number or the ID number. In the civil registration number column, please enter the civil registration number correctly using this format: ”xxxxxx-xxxx”. For example ”16 August 1965” will not be accepted.

Example – start and end dates:

The Start date and End date fields are mandatory.

The system only accepts this date format: ”14-02-2015”. The system does not accept these date formats: ”31-07-14” and ”Jan. 14”, an empty field or ”ongoing”. If a relationship continues in 2017, please enter ”31-12-2016” in the end date field. 

Example – format changes:

The validation may fail if changes are made to headings, the formats of fields or if more sheets are added to the template. For example, you may have added an additional column for information about the type of relationship.

Another example is a border added to a cell to distinguish between different trials. Such changes may affect the validation of the Excel sheet when you try to attach it to the e-form.

If the validation still fails after you have made all the corrections listed in the error message, please send us a screenshot of the error message by email to Send an email