The Common Baltic Package Guidance has been updated to be in line with the amended Directive 2001/83/EC and QRD template. Some amendments have been made to the sections 2 and 3 of outer carton to regulate the usage of Latin and national languages. New explanatory information about list of excipients has been added to the section 3 to provide clearer guidance and thereby to simplify preparing common package.

This guidance replaces the previous version dated May 2005 (guidance2009.pdf).