Procedures for summaries of product characteristics, package leaflets and labelling
Preparation of product information
Translations of product information
Guidance on Nordic packages
The documents 'Guideline on Nordic packages' and 'Questions & Answers' 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' contains general information on Nordic packages, whereas the 'Questions & Answers' 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, should be used. The documents are prepared in cooperation between the medicines agencies in Denmark, Finland, Iceland, Norway, and Sweden.