Sweden Medical Products Agency - Practical guidance for submissions

Practical guidance for submissions

1. Application for marketing authorisation

Please consider the CMDh recommendations for the cover letter and preferably use the published template (see link to the right).

1.1. Electronic submissions on CD/DVD

Electronic-only submissions (eCTD, NeeS or VNeeS format) are strongly encouraged. A filled “Confirmation of transition to electronic-only submissions” should be submitted together with extension applications to clarify that all future submissions also for other strengths and forms of the product applied for will be submitted electronic only.

The criteria for accepting electronic submissions as originals in all procedures are that the current ICH and EU specifications and the EU eCTD harmonised guidance or the EU NeeS harmonised guidance are followed. The submissions have to pass the technical validation at the MPA.

If the submission requires more than one CD, a DVD is preferred. The CD/DVD should be packed adequately to prevent damage. Each CD/DVD should be properly labelled in accordance with current EU guidance.

The applicant is responsible for checking the CD/DVD for viruses.

Avoid submitting documents in several different formats, unless they are so called working documents.

All submissions, whether entirely on paper or on CD/DVD, should have a paper cover letter with submission subject clearly stated. Original signature is not needed. If in electronic format, the cover letter should also be included on the CD/DVD.

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