Medicinal products without a Danish marketing authorisation can now be prescribed and dispensed

Recently, the Danish Medicines Agency (DMA) announced how it intends to use and manage a new system, according to which the DMA has the authority to issue dispensing permits on its own initiative for medicinal products without a Danish marketing authorisation.

On 1 January 2024, an amendment of the Danish Medicines Act entered into force granting the Danish Medicines Agency the authority to allow, on its own initiative, the prescription and dispensing of medicinal products without a Danish marketing authorisation in special circumstances. We have previously sent out an insight on the amendment of the Danish Medicines Act, see here.

Special circumstances are, for instance, in case of supply failure or if there is a risk of supply failure, in which case it would be appropriate to dispense a medicinal product that has not been marketed in Denmark. 

The Danish Medicines Agency has set up two new websites for this new system: 

  1. For pharmaceutical companies: Alternatives from other countries in case of supply failure (laegemiddelstyrelsen.dk) (in Danish)
  2. Medicinal products from other countries allowed under Section 29(2) of the Medicines Act (laegemiddelstyrelsen.dk) (in Danish)

The Danish Medicines Agency will use the first website to announce to pharmaceutical companies if the DMA is experiencing supply failure of medicines being marketed in Denmark, so that the pharmaceutical companies can inform the DMA of possible alternatives from other countries. 

The second website the DMA will use to publish a list of medicinal products from other countries having been approved for sale and dispensing without any prior application from a doctor, dentist or veterinarian under the new system.

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Read The Danish Medicines Agency's announcement (in Danish)

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