Companies covered by the rules
Definition of pharmaceutical companies covered
Pharmaceutical companies are defined as companies having obtained an authorisation under section 7(1) or section 39(1) of the Danish Medicines Act, or a representative in Denmark of a foreign company holding such an authorisation or authorised under Article 44, 47, 49, 52, 53 or 54 of regulation 2019/6 of 11 December 2018 on veterinary medicines, with the exception of public hospitals.
Healthcare professionals who have a duty to give notice of or apply for approval of their relationship with pharmaceutical companies
- Proprietary pharmacists
- Prescribing pharmacists
- Midwives
- Doctors
- Nurses
- Dentists
Healthcare professionals who have a duty to give notice of financial support provided to pharmaceutical companies
- Bioanalysts, incl. students
- Pharmacists, incl. students
- Pharmacy technicians, incl. students
- Midwives, incl. students
- Clinical dieticians, incl. students
- Doctors, incl. students
- Radiographers, incl. students
- Social and healthcare assistants, incl. students
- Nurses, incl. students
- Dentists, incl. students
- Veterinarians, incl. students
- Veterinary nurses, incl. students
The following healthcare professionals have a duty to give notice of financial support provided to pharmaceutical companies:
- Owners of and senior staff of stores authorised to sell OTC medicines permitted for sale outside pharmacies or medicinal products for production animals (see section 35 – link to section)
- Persons who offer commercial advice on and buy medicinal products outside pharmacies, including persons in the hospital sector (see section 36)
- Persons who offer commercial advice on medicinal products mean persons who, for business purposes, offer professional advice on medicinal products to municipalities, regions, the state, hospitals and other healthcare institutions.
- For example, consultants and other persons offering professional advice on medicinal products as part of their business operations. The provision does not include employees at pharmacies or medical sales representatives employed by a pharmaceutical company.
- Persons who purchase medicinal products are defined as persons who are employed to purchase medicinal products, i.e. purchasing agents employed at hospitals, in regions, municipalities or self-governing institutions.
Link to list of pharmaceutical companies covered by the rules
Definition of medical device companies covered and medical device companies manufacturing, importing or distributing products without an intended medical purpose
Medical device companies are defined as undertakings established in Denmark which manufacture, import or distribute medical devices in risk class IIa, IIb or III, or in vitro diagnostic medical devices, and representatives of such companies, except public hospitals.
Companies manufacturing, importing or distributing products without an intended medical purpose are defined as Danish manufacturers, importers and distributors of products without an intended medical purpose listed in Annex XVI of the EU Regulation No. 2017/745 on medical devices, and which are in risk classes II a, II b and III, as well as EU representatives, established in Denmark, for a manufacturer of these types of products. In the following, this type of company is referred to as a company covered by section 5b(5) of the Danish Act on Medical Devices.
Healthcare professionals who have a duty to give notice of/apply for approval of a relationship with medical device companies and medical device companies manufacturing, importing or distributing products without an intended medical purpose
- Proprietary pharmacists
- Doctors
- Nurses
- Dentists
Healthcare professionals who have a duty to give notice of financial support provided to medical device companies and medical device companies manufacturing, importing or distributing products without an intended medical purpose
- Bioanalysts, incl. students
- Pharmacists, incl. students
- Pharmacy technicians, incl. students
- Midwives, incl. students
- Clinical dieticians, incl. students
- Doctors, incl. students
- Radiographers, incl. students
- Social and healthcare assistants, incl. students
- Nurses, incl. students
- Dentists, incl. students
Specialists who have a duty to give notice of financial support provided to medical device companies and medical device companies manufacturing, importing or distributing products without an intended medical purpose
- Owners of and senior staff of stores selling medical devices (see section 19)
- Medical technicians and other persons who, for business purposes, offer advice on medical devices and buy medical devices (see section 20)
- For example, medical technicians, medical engineers, consultants and other persons offering professional advice on medical devices or medical devices without an intended medical purpose as part of their business operations. The provision does not include medical device consultants employed by a medical device company.
- Persons who buy medical devices or medical devices without an intended medical purpose mean persons who are employed to buy medical devices. For example, purchasers employed at hospitals, in regions, municipalities, self-governing institutions or private clinics.
List of medical device companies covered by the rules
List of medical device companies manufacturing, importing or distributing products without an intended medical purpose
Definition of stores specialised in the sale of medical devices
Stores specialised in the sale of medical devices are defined as stores established in Denmark and specialised in the sale of medical devices in risk class IIa, IIb or III, or in vitro diagnostic 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.
Healthcare professionals having a duty to give notice of/apply for approval of their relationship with stores specialised in the sale of medical devices
- Doctors
List of stores specialised in the sale of medical devices covered by the rules