Magistral medicines

Updated 03 May 2018

Magistral medicines are medicinal products prepared in a pharmacy for an individual patient or animal in accordance with a prescription from a doctor or veterinarian (see section 11(1) (i) of the Danish Medicines Act, consolidation act no. 99 of 16 January 2018).

Private pharmacies (in primary sector) are not allowed to prepare magistral medicines if other medicinal products having the same therapeutic efficacy are available in the market (see section 13(2) of the Danish act on pharmacy practice, consolidation act no. 801 of 12 June 2018).

Permission for magistral preparation of medicinal products for human use

In special cases, the Danish Medicines Agency can, following an application from the patient’s doctor, grant permission to a pharmacy to prepare a magistral medicine having the same therapeutic efficacy as a medicinal product that is available in the market (see section 13(5) of the Danish act on pharmacy practice, consolidation act no. 1040 of 3 September 2014).

When is permission required?

You do not have to apply for permission to prepare all types of magistral medicines. If a medicinal product with the same therapeutic efficacy is not available in the market, permission is not required. However, if the magistral medicine has the same therapeutic efficacy as a marketed medicinal product, the patient's doctor must apply for permission so that the pharmacy can prepare the magistral medicine.

If the pharmacy or the doctor is unsure whether a permission is required in a specific case, please call us on +45 44 88 96 96.

Doctors can apply to us for permission to prepare a magistral medicine by using the encrypted form below (in Danish only).

To use the form, you need your digital employee signature.

You can also send the application by ordinary post to:

Danish Medicines Agency
Pharmacies & Reimbursement
Axel Heides Gade 1
DK-2300 Copenhagen S

There are no format requirements for the application.

Permissions are issued to the patient. Until August 2015, we issued permissions to the doctor who submitted the application. These permissions may still be used, regardless of the doctor who prescribes the magistral medicine.

If you have any questions, please call us on +45 44 88 96 96.

Form

Permission for magistral preparation of medicinal products for human use (in Danish, opens in a new window)

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.

Magistral medicines for veterinary use

Please contact the Danish Veterinary and Food Administration, which administers the rules on the use of magistral medicines for veterinary use (in Danish)

  • Magistral preparation of red morphine drops

    | 14 October 2016 |

    The Danish Medicines Agency has reviewed relevant available literature and not seen any documentation that there is a significant difference in the therapeutic efficacy of magistral red morphine drops and the marketed medicinal product Oramorph, oral drops and oral solution - regardless of any difference in the strength of the medicinal products.

  • Magistral preparation of hydrocortisone tablets 5 mg

    | 14 October 2016 |

    Hydrocortisone Orion 10 mg tablets are now marketed as scored tablets that can be divided into two equal doses.

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