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Application for parallel import

Updated 14 August 2012

Parallel import implies that a medicine, for which the Danish Health and Medicines Authority has already granted a marketing authorisation, is imported into Denmark through other distribution channels than the ones agreed with the patent holder.

Foreign as well as Danish medicines may be imported in parallel, and it may be human as well as veterinary medicines.

Certain minor deviations in a parallel imported product are acceptable provided the imported product has no therapeutic difference from the original - and directly distributed - product.

Guidelines

Guidelines on parallel import of medicinal products

Application forms

Application form for a parallel import marketing authorisation for an already approved medicinal product (e-form) (in Danish only)