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Parallel-imported medicines and substitution

  • Published: November 30, 2020
  • Last updated: November 30, 2020

A parallel-imported medicine is a drug that is imported into Sweden from another EU or EEA country. The Swedish MPA issues a marketing authorisation for each parallel-imported medicine and decides whether or not it is substitutable. Like other medicines, they are divided into groups made up of mutually substitutable medicines.

A substitution group may include parallel-imported drugs that refer to directly imported drugs within the same group. Direct imports may be both original drugs and generic ones. As a result, within the same substitution group, one parallel-imported drug may refer to an original drug while another refers to a generic drug.

For information on how parallel-imported and directly imported drugs relate to each other, please use Läkemedelsfakta to search for the parallel-imported drug. The 'Registration information' tab includes information such as which is a directly imported medicine, which country the parallel-imported medicine is imported from, and also what differences there are compared to the directly imported product.

Just as in the other cases, prescribers may refuse substitution on medical grounds when there are parallel-imported alternatives.

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Swedish Medical Products Agency (Läkemedelsverket)
Opening hours: weekdays 8:00 am to 4:30 pm CET
Telephone: +46 (0)18-17 46 00
Email: registrator@lakemedelsverket.se

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