How should the summary of product characteristics in Swedish be submitted for new Marketing Authorisation applications, which are currently under assessment?

For Marketing Authorisation applications which are submitted after 9.2.2019 a Swedish summary of product characteristics is required and the Marketing Authorisation will not be granted without it. For Marketing Authorisation applications which are submitted before 9.2.2019 a Swedish summary of product characteristics can be submitted by a national type IB variation after the Marketing Authorisation is granted. The Swedish summary of product characteristics can also be submitted at the national phase of the Marketing Authorisation application.