Application for parallel import

Updated 09 July 2021

Parallel import implies that a medicine, for which the Danish Medicines Agency 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 on parallel import of medicinal products

Labelling and repackaging of parallel imported medicinal products (in Danish)

Specification of requirements for parallel importers using 'batch pooling'

Guidelines for application for a parallel import marketing authorisation of an already authorised medicinal product

Guidelines for application for renewal of parallel import marketing authorisation

Application forms

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

Application for renewal of marketing authorisation for parallel import of an already authorised medicinal product (e-form) (in Danish only)

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