The list came into force on 15 June 2009.
For products with a marketing authorisation, the list is based on the marketing authorisations valid on the date the list in question was issued. For marketing authorisations granted after this date and amendments to such marketing authorisations, the conditions and restrictions indicated in the marketing authorisations apply.
The following documents have been created by Nordic medicine agencies:
- Guideline on Nordic packages
- Frequently Asked Questions
- Question form - Question to the Nordic package group
- Request for a Nordic mock-up cooperation
All documents are published on the website of the Medical Products Agency (Sweden).
The documents Guideline on Nordic packages and Frequently Asked Questions are documents that 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.
Request for a joint Nordic assessment of mock-ups, please use the form ”Request for a Nordic mock-up cooperation”.