Asset Publisher
null
Can the submission of the summary of product characteristics in Swedish be combined with some other kind of variation application?
Can the submission of the summary of product characteristics in Swedish be combined with some other kind of variation application?
A summary of product characteristics in Swedish can’t be combined for exampla with a renewal, type II variation application or with an application of transfer of a marketing authorisation to a new holder. Addition of a summary of product characteristics in Swedish must be applied by a national type IB variation, which can be grouped with an appropriate clinical (classification C) variation.
4 Apr 2019