Swissmedic Guidance on Marketing Authorization Transfers

Swissmedic’s guidance (ZL404_00_001) outlines the legal framework and process for transferring marketing authorizations of human and veterinary medicinal products, effective 01-May-2023. Based on Art. 10 of the Therapeutic Products Ordinance (TPO) and FeeO-Swissmedic, a written transfer application must be submitted at least three months prior, including a declaration and completed HMV4 form. The new holder assumes all rights and obligations, including batch release. Transitional arrangements allow sticker updates for packaging and healthcare information. Transfer fees are outlined in FeeO-Swissmedic, and Swissmedic may ensure compliance.

Source:https://www.swissmedic.ch/dam/swissmedic/de/dokumente/zulassung/zl_hmv_iv/zl404_00_001d_wluebertragungderzulassung.pdf.download.pdf/zl404_00_001d_wluebertragungderzulassung.pd

Region: Switzerland