Sweden publishes revised guideline on Nordic packages

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.