Changes to guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4

01.05.2022

Clarifications on the prioritisation and fast-tracking of pandemic medicinal products and on the patient information requirements

Swissmedic will continue to give priority to authorisation 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 authorisation applications for pandemic medicinal products are to be assessed in line with the official time limits for the fast-track or temporary authorisation procedure (in accordance with the guidance document Time limits for authorisation 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 TPO.

The revised guidance document is valid with effect from 1 May 2022.

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