Transfer of Marketing Authorisation for medicinal products managed in eCTD format

Can an application to transfer the authorisation be submitted in eDok format when submissions for the medicinal product have been in eCTD format?

Applications to transfer an authorisation are generally submitted by the future Marketing Authorisation Holder. Applications for medicinal products managed by the previous Marketing Authorisation Holder in eCTD format may, according to the revised Therapeutic Products Act, no longer be submitted outside the eCTD Life Cycle. The rule of thumb is «once eCTD, always eCTD». This means that the future Marketing Authorisation Holder, as the company submitting the application, has to submit the application to transfer the authorisation in a subsequent eCTD sequence via the eGov portal. Swissmedic merges the eCTD Life Cycle.. The future Marketing Authorisation Holder should check that the application appears correctly on the Swissmedic portal, once the application has been submitted.

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Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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