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.