Sweden publishes revised guideline on Nordic packages

25 February, 2015

On behalf of the medicines agencies of the five Nordic countries (SE, DK, NO, FI, IS), the Swedish MPA has published Edition 2 of the Guideline on Nordic Packages for human and veterinary medicines:

  • The Guideline on Nordic Packages can be found here.

  • A Question and Answer document relating to the guideline can be found here.

Links to two other useful forms can also be found here:

  • A form for asking additonal questions to the Nordic Package Group.

  • A form for requesting a Nordic mock-up assessment cooperation.

The procedure for requesting Nordic mock-up assessment cooperation is in a recently extended pilot phase and the Nordic package group would urge more applicants to make use of this facility.

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