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 covered by pharmaceutical companies
- Proprietary pharmacists
- Prescribing pharmacists
- Midwives
- Doctors
- Nurses
- Dentists
Link to list of pharmaceutical companies covered by the rules
Definition of medical device companies covered by the rules
Medical device companies are defined as companies established in Denmark that manufacture, import or distribute medical devices in risk class II a, II b or III, or in vitro diagnostic medical devices, and representatives of such companies, with the exception of public hospitals.
Healthcare professionals covered by medical device companies
- Proprietary pharmacists
- Doctors
- Nurses
- Dentists
List of medical device companies covered by the rules
Definition of medical device companies manufacturing, importing or distributing products without an intended medical purpose:
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 covered by medical device companies manufacturing, importing or distributing products without an intended medical purpose:
- Proprietary pharmacists
- Doctors
- Nurses
- Dentists
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 covered by stores specialised in the sale of medical devices
- Doctors
List of stores specialised in the sale of medical devices covered by the rules