Application for compassionate use permits for veterinary use

Updated 24 October 2018

Please submit your application electronically as this will ease our processing of applications. You need a NemID employee signature for this purpose.

Guidelines

Guidelines for application for a compassionate use permit, veterinary (in Danish only)

Need to apply for a compassionate use permit or permission to use a magistral medicinal product?

Compassionate use permits are only issued for medicines manufactured by pharmaceutical companies.

The Danish Medicines Agency does not grant permission to use a magistral medicinal product (product prepared by a pharmacy) for animals. These applications must – in special cases – be submitted to the Danish Veterinary and Food Administration. Veterinarians can apply for permission to use a magistral medicinal product, which is not listed in Annex 2 of Executive Order 1353 of 29 November 2017 on Veterinarians use, dispensing and prescription of Veterinary Medicines (Danish title: “Bekendtgørelse om dyrlægers anvendelse, udlevering og ordinering af lægemidler til dyr”).

Pursuant to section 11(1) (i) of the Danish Medicines Act, magistral medicinal products are defined as medicinal products prepared in a pharmacy for an individual patient or animal in accordance with a prescription from a doctor or a veterinarian

Forms

Application for single compassionate use permit, veterinary (in Danish only)

Application for general compassionate use permit, veterinary (in Danish only)

If you have a NemID (in the form of an employee signature), you can easily send the application form to the Danish Medicines Agency electronically by clicking ‘Signer’ (sign) at the bottom of the form. Please note that we have only received your application if immediately after submission you receive a receipt containing a reference number which you are to use when making later inquiries to the Danish Medicines Agency. We encourage the use of electronic applications as it eases our administrative processes for the benefit of the review of the application.

If you do not have a NemID, you can fill out the form on the screen and print it by means of the print icon on the tool bar below. The printout page size must be A4. Sign the form and either fax it to the Danish Medicines Agency on +45 4488 9117 or scan it and send it by email to: udleveringstilladelser@dkma.dk.

Note: You have 20 minutes to complete and submit the form after you have opened it. If you spend more time, we will not receive your form.

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