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Swiss Medic Guidance: Authorisation Procedures for Covid-19 Medicinal products

Yesterday (01.08.2022) the Swiss Medic updated their "Guidance document on Authorisation procedures for Covid-19 medicinal products during a pandemic HMV4". In the exceptional situation of a pandemic, Swissmedic is offering applicants various options for the fastest possible processing of authorisation applications for medicinal products used to prevent and treat a pandemic disease.

This guidance document is primarily intended for administrative bodies and does not directly specify the rights and obligations of private individuals. This guide applies to new authorisations and type II variations, i.e. additional indications used to prevent or treat COVID-19

Swissmedic uses this guide mainly as a resource for deciding on possible authorisation procedures in the exceptional situation of a pandemic in a consistent and equitable manner.

For applicants, its publication is intended to elucidate the specific preconditions and requirements that must be fulfilled so that procedures can be used and applications processed as quickly and efficiently as possible during a pandemic.

Review process:

The marketing authorisation holder informs Swissmedic in advance of the exact submission date so that the formal check by Swissmedic can be carried out promptly. Depending on the classification of the safety relevance, the deadlines may be shortened appropriately to ensure rapid inclusion in the medicinal product information.

CLICK this LINK to know more about Authorisation procedures for Covid-19 medicinal products during a pandemic.


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