![]() 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: 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). Inform healthcare professionals about the report It requires a NemID employee signature to use the form above. ![]() Report a relationship with healthcare professionals (e-form) (in Danish only) Here company owners or company representatives can submit a report about healthcare professionals who have had a relationship with the company: Reports must be submitted annually no later than 31 January. 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. The duty to inform means that your company must inform doctors of the rules when you establish a relationship with a doctor. Stores specialised in the sale of medical devices 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. 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. 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. 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.Ī store is a specialised distributor if medical devices account for more than 50% of the store’s product range and turnover. ![]() 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. 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 companies with permission subject to section 7(1) (marketing authorisation) or section 39(1) (company authorisation) of the Danish Medicines Act. Pharmaceutical companies, medical device companies and stores specialised in the sale of medical devices have a reporting obligation and a duty to inform. Here are six important things you need to know about the reporting obligation and the duty to inform: 1. Stores specialised in the sale of medical devices have a reporting obligation and a duty to inform when they establish a relationship with doctors. Pharmaceutical and medical device companies have a reporting obligation and a duty to inform when they establish a relationship with a healthcare professional.
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