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DATA PRESENTATION

Compassionate use permits

DATABASE

Primary variables

Introduction

Compassionate Use Permits System administers dispensing authorisations for medicines that are not approved or marketed in Denmark.

As a general rule, it is unlawful to sell and dispense medicine that is not approved either by the Danish Medicines Agency or the EU Commission, but in special cases it may be temporarily necessarily to treat a patient with a non-approved medicine although this requires a dispensing authorisation which is available on application to the Danish Medicines Agency by doctors, dentists or vets.

Before granting a dispensing authorisation, the Danish Medicines Agency assesses whether this involves a special therapeutic reason for using an unauthorised drug, whether there is documentation for its efficacy for treating the disease concerned and that the quality is satisfactory and it is safe to use. The Danish Medicines Agency deals with around 9000 applications a year and these often relate to drugs already approved in other countries.

 

More details

Type
Clinical support register
Purpose
Administration

Collection Period

Collection Period
Coverage
Nationwide
Population
The register holds compassionate use permits
Database Categories

Application requirements

Compassionate Use Permits allows doctors, veterinarians and dentists to apply for an authorization to sell or deliver medicinal products not marketed in Denmark.

The application can be filled in paper form or electronically via the Danish Medicines Agency's website (using NemID Employee Signature).

Application process

  • Fill out an application and send it to the Danish Medicines Agency
  • The applicant will receive a reply to the application
  • The applicant must notify the pharmacist himself by placing a copy of the delivery permit at the prescription

Contact information

Data owner
Danish Medicines Agency
Contact data owner
Islands Brygge 67
2300 København S
Website - data owner
bit.ly/danish-medicines-agency
Data administrator
The Danish National Archives
Contact data administrator
The Danish National Archives
T: 33 92 33 10
E: Mailbox@sa.dk
Website - data administrator
bit.ly/danish-national-archives