The Nordic Medicinal Agencies release Guidance on Nordic packages

Friday, February 21, 2014

The new documents Guideline on Nordic packages and Frequently Asked Questions have been prepared in order to facilitate the regulatory work when making common Nordic medicinal packages.

These documents apply to medicinal products for both human and veterinary use. The Guideline on Nordic Packages document contains general information on Nordic packages, whereas the Frequently Asked Questions document gives detailed advice on different package issues. Marketing authorisation holders may submit questions regarding issues relating to Nordic packages.  For this purpose a specific form, Question to the Nordic package group, is published and should be used. The documents are a product of cooperation between the Medicines Agencies in Denmark, Finland, Iceland, Norway, and Sweden.


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