Application for parallel import or parallel trade

Updated 10 May 2022

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.

Parallel import and parallel trade can include both foreign as well as Danish-produced medicines. Parallel import is import of a human medicine and parallel trade is import of a veterinary medicine.

In general

Forsøgsordning for udtagning af digitale retentionsprøver ved ompakning af parallelimporterede lægemidler (in Danish only)

Parallel import – questions and answers

Ompakning af parallelimporterede lægemidler – etiketter til den indre emballage (in Danish only)

Specification of requirements for parallel importers using 'batch pooling'

 

Parallel import

Guidelines on parallel import of medicinal products

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

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

Kom godt i gang med elektroniske ansøgninger om parallelimport (in Danish only)

Guidelines for application for renewal of parallel import marketing authorisation

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

 

Parallel trade

Parallel trade is described in article 102 in the Regulation.

National procedure rules for parallel trade in veterinary medicines are laid down in the executive order on parallel trade in veterinary medicines (in Danish only).

National guidelines on parallel trade in veterinary medicines (in Danish only).

Danish application form to be used to apply for authorisation to parallel trade a veterinary medicine is pending. Danish application form for notification of changes to medicines that are parallel traded is also pending.

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