Pharmaceutical Companies and Medical Device CompaniesWhat 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
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.
- 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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