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Swedish MPA accepts electronic submission on route to full digitalisation

This article was originally published in SRA

Executive Summary

Sweden’s Medical Products Agency is now accepting electronic submissions for marketing authorisation applications filed under the European centralised procedure1. The agency has further confirmed that it plans to accept electronic submissions for the other authorisation procedures - the mutual recognition and decentralised procedures as well as national procedures - from 1 April. The MPA will accept two electronic formats for submissions: electronic Common Technical Documents; and non eCTD electronic Submissions.

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