Medicinal product groups - substitution groups

Updated 24 April 2015

Medicinal products with the same active constituent in related pharmaceutical forms can mutually replace each other. The system is called generic substitution of synonymous medicinal products and has been used in Denmark since November 1991.

On the basis of the Executive Order on Prescriptions, the Danish Medicines Agency has established substitution groups for as many packages of medicinal products as possible.

The groups are fixed, i.e. all packages in a group must be able to be substituted mutually and substitutions cannot be made with packages outside of the group. Grouping of packages therefore follows these guidelines in the following order:

  • at the most, there may be 10 pct (25 pct for medicinal products in dispensing group B) divergence in the size of package from the smallest package to the largest package in the group.
  • as many packages as possible must be placed in the same substitution group.
  • if it is not possible to include all packages within a group, the package that is furthest percent-wise from the rest of the packages is omitted (defined substitution groups).
  • the percentage calculation is made on the basis of the smallest package size in the group.

There will always be packages that cannot be included in the substitution groups due to the large variation in package sizes on the market.

The above-mentioned guidelines are laid down to create the largest groups possible and hence the greatest opportunity for competition within the groups.

Reimbursement groups

Reimbursement groups are a grouping of medicinal products that are entitled to reimbursement and can be mutually substituted. Reimbursement groups and substitution groups for medicinal products entitled to reimbursement have been entirely merged.

This merging between reimbursement groups and substitution groups ensures that the customer can get the medicinal product dispensed that forms the basis for the group's reimbursement price (unless substitution has not been opted for by the doctor or by the customer her/himself).

In every reimbursement group, a common price for reimbursement is calculated, which is the same for all medicinal products in the group. The reimbursement price is the cheapest medicinal products in every reimbursement group.

Reimbursement groups are formed on the basis of the National Health Security Act.

You can get additional information on reimbursement prices at www.medicinpriser.dk

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