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  • Medical device

    I need to submit a variation application for a medical device with ancillary medicinal substance. Under "Choose submission type" I'm not able to locate choose this as it doesn't come up as an option. Can you please clarify what I should choose for a variation application for a medical device with ancillary medicinal substance included. There is no information regarding this in the IRIS guide for applicants, version 3.7.

    Thank you. 

    Mariann Jeremiassen