Pharma and medical device regulation—Denmark—Q&A guide

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Pharma and medical device regulation—Denmark—Q&A guide
  • 1. Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.
  • 2. Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?
  • 3. Describe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.
  • 4. What legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?
  • 5. What requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?
  • 6. Are there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?
  • 7. How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?
  • 8. What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?
  • 9. To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?
  • More...

Pharma and medical device regulation—Denmark—Q&A guide

This Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical device regulation in Denmark published as part of the Lexology Getting the Deal Through series by Law Business Research (published: August 2020).

Authors: Accura Advokatpartnerselskab—Morten Bruus; Christoffer Ege Andersen

1. Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.

The Danish healthcare system can generally be divided in the following manner.

  1. State: the Ministry of Health is responsible for establishing the overall framework of Danish healthcare, including legislation on the organisation of healthcare services, medicinal products and medical devices.

  2. Regions: the five regions are responsible for public hospitals and general practitioners. The vast majority of the medicinal products and medical devices dispensed at public hospitals are purchased through a company named Amgros, which is a partnership between the five regions. Amgros carries out tendering procedures and purchases medicinal products and medical devices for all public hospitals. Further, the regions are responsible for hospital pharmacies.

  3. Municipalities: the 98 municipalities are responsible for home care.

  4. The private sector: Denmark has a number of private hospitals operating alongside the public hospitals within many therapeutic areas. Private pharmacies are privately owned and have a monopoly on the sale of prescription-only medicinal products and some over-the-counter medicinal products.

2. Identify the competent authorities for

Popular documents