Companies' reporting obligation and duty to inform about relationships
Pharmaceutical and medical device companies have a reporting obligation and a duty to inform when they establish a relationship with a healthcare professional. Stores specialised in the sale of medical devices have a reporting obligation and a duty to inform when they establish a relationship with doctors.
Here are six important things you need to know about the reporting obligation and the duty to inform:
1. Companies covered by the rules
Pharmaceutical companies, medical device companies and stores specialised in the sale of medical devices have a reporting obligation and a duty to inform.
Pharmaceutical companies
The rules apply to companies with permission subject to 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.
Medical device companies
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.
Stores specialised in the sale of medical devices
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.
2. Companies with a duty to inform
When establishing a relationship with one of the healthcare professionals mentioned below, pharmaceutical and medical device companies as well as stores specialised in the sale of medical devices must inform the person of his/her notification duty and obligation to apply for permission as well as the Danish Medicines Agency’s publication of the relationship.
Pharmaceutical companies
The duty to inform means that your company must inform doctors, dentists, proprietary pharmacists and prescribing pharmacists of the rules when you establish a relationship with them.
Medical device companies
The duty to inform means that your company must inform proprietary pharmacists, doctors, nurses and dentists of the rules when you establish a relationship with them.
Stores specialised in the sale of medical devices
The duty to inform means that your company must inform doctors of the rules when you establish a relationship with a doctor.
3. Companies must report annually
Pharmaceutical and medical device companies as well as stores specialised in the sale of medical devices must inform the Danish Medicines Agency about the healthcare professionals they have had a relationship with.
Reports must be submitted annually no later than 31 January. Here company owners or company representatives can submit a report about healthcare professionals who have had a relationship with the company:
Form
It requires a NemID employee signature to use the form above.
Inform healthcare professionals about the report
Simultaneously with the report to the Danish Medicines Agency, the company must inform the relevant doctors, nurses, dentists, proprietary pharmacists and prescribing pharmacists of the contents of the report (the information about the person reported to the Danish Medicines Agency).
4. Guidelines
In the guidelines, you can read more about the reporting obligation and the duty to inform, the Danish Medicines Agency’s use of reports and the consequences of any failure to report:
5. Frequently asked questions
Read more about how you submit reports, what you need to report or get help with technical problems in connection with the report:
6. Changes to reports
If you discover any errors in your reports to the Danish Medicines Agency, you have to submit a new report. A revised list should be attached to the new report. It is inadequate to only submit the changes only.
Legislation
Pharmaceutical companies
The Danish Medicines Act provides the legal framework for pharmaceutical companies’ reporting obligation and duty to inform when they establish a relationship with a healthcare professional.
The specific rules on pharmaceutical companies having a relationship with healthcare professionals appear from: the Danish executive order no. 693 of 9 July 2019 on healthcare professionals’ relationships with pharmaceutical and medical device companies and stores specialised in the sale of medical devices (in Danish only).
Medical device companies
The Danish Act on Medical Devices provides the legal framework for medical device companies’ and stores’ reporting obligation and duty to inform when they establish a relationship with a healthcare professional.
The specific rules on medical device companies and stores having a relationship with healthcare professionals appear from: 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 only)