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Swissmedic Guidance: Temporary Authorisation to Use an Unauthorised Medicinal Product

A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a clinical trial approved in Switzerland, so that patients outside of the clinical trial may use the Medicinal Product (MP) tested in the trial without marketing authorisation.

In order to be considered for approval in a clinical trial, the Medicinal Product (MP) must be the same as the Investigational Medicinal Product (IMP) that was used in the relevant Swissmedic approved clinical trial.


This guideline clarifies the requirements for new applications for temporary authorisations of use of unauthorised medicinal products as well as requirements for changes and reporting during the course of such an authorisation.


Before submitting the dossier for authorisation to Swissmedic, the sponsor must obtain a positive decision from the Ethics Committee who approved the reference clinical trial.


The Sponsor should complete the application form and submit to Swissmedic the relevant documents mentioned in "Guidance on the new submission process and Quick instruction for use of new submission form".


After the marketing authorization has been granted, the sponsor must notify Swissmedic that the MP is available on the Swiss market, so that Swissmedic can revoke the Temporary Authorization.


Click this LINK to know more about details on Timelines and application fees related to Temporary Authorisation.


Also check out another updated guidance on the submission process "Guidance on the Submission Process for Clinical Trials with Medicinal Products"


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