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Denmark
transparency obligations overview

Latest update: 14 September 2018 | Important Notes

Report Due Date

31 January, annually

Authority

Danish Health and Medicines Authority

Who Must Report

Pharmaceutical and medical device companies (see details in text)

Covered Recipients

Doctors, nurses, pharmacists and dentists

Pharmaceutical Companies and Medical Device Companies

What is reported:

Transfers of value with any healthcare professionals (HCPs) with whom the company has collaborated, including services between industry and HCPs, such as:

  • Research cooperation
  • Speaker arrangements
  • Training services
  • Consultancies

Include name, CVR number, the associated healthcare professional’s full name, primary place of work, home address, authorisations ID or social security number and time period for the association. However, it is important to note that Class I products are exempt from these transparency rules.

Who must report:

Pharmaceutical and medical device companies, including:

  • Companies authorized by the Danish Medicines Act § 7, paragraph 1 (marketing) or a license under § 39 paragraph 1 (business license). Public hospitals and the regional drug organization Amgros are not covered.
  • Manufacturers that market medical devices in hazard class IIa, IIb or III, medical devices for in vitro diagnostics or active implantable medical devices, representatives of the manufacturers of this type of product, as well as importers and distributors of this type of product, established in Denmark are covered by the rules.
  • Stores established in Denmark, specialized medical equipment suppliers in risk class IIa, IIb or III, medical devices for in vitro diagnostic or active implantable medical devices and representatives of such transactions are covered by the rules. This includes specialized businesses when medical equipment accounts for more than 50 percent of the store’s product range and turnover.

How to Report

  1. Log in with NemID employee signature (read more and create through NemID business) to https://www.nemid.nu/dk-da/erhverv/
  2. Check email address.
  3. Choose the year for the report.
  4. Attach completed template
  5. Before signing the form, you must have completed and saved the information about the associated health professionals in the template.
  6. See information through the summary page
  7. Print before submitting if you want a copy of the report. Do this by clicking on the print icon.
  8. Click SUBMIT.
  9. You will receive a receipt sent to the email you provided.

HCP Obligation

Link for HCPs to apply for permission to work with companies.
(HCPs have to report the actual fees received. Furthermore, medical device companies have the obligation to inform the Danish HCPs of their obligation to report/apply for permission.):
Danish Medicines Agency

Note

Third-party-organised conferences and company-organised events that take place outside Denmark fall within the scope of the new transparency obligations. The scope of the HCPs under this reporting obligation is even wider: doctors, dentists, pharmacists, nurses, pharmacy assistants, midwives, bioanalysts, clinical dietitians, radiographers, social and healthcare assistants or students in these disciplines, as well as owners and senior executives in stores selling medical devices, as well as medical technicians must report sponsorships to the National Health Board, where it will be public information. There is no reporting obligation on the company in these cases.
Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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