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null How to submit a Swedish summary of product characteristics to Fimea?

How to submit a Swedish summary of product characteristics to Fimea?

The primary means of submission of a Swedish SPC (national type IB (C.I.z) application) is through CESP in eCTD format. A Swedish SPC can also be submitted outside the eCTD. If sent by post, the submission should be accompanied by a paper cover letter and include the material in electronic format on a CD. For additional information, please see the instructions for electronic marketing authorisation submissions.

19 Oct 2020