Changes to guidance document Authorization procedures for Covid-19 medicinal products during a pandemic HMV 4 – Clarifications on the prioritization and fast-tracking of pandemic medicinal products and on the patient information requirements

29. April 2022 – Swissmedic will continue to give priority to authorization applications for medicinal products used to prevent and treat a pandemic disease (e.g. Covid-19) and fast-track these according to the pandemic situation so that effective and safe medicines can be made available to patients as quickly as possible. If authorization applications for pandemic medicinal products are to be assessed in line with the official time limits for the fast-track or temporary authorization procedure (in accordance with the guidance document Time limits for authorization applications HMV4), the corresponding requests must be made before the application is submitted. These requests will also be given priority and fast-tracked in line with the pandemic situation. As a further clarification, Swissmedic states that patient information (if available) for pandemic medicinal products must also be provided in the official languages as set out in Art. 26 para. 2 Ordinance on Medicinal Products.

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