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Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)

Swissmedic, the Swiss Agency for Therapeutic Products, has published comprehensive guidance "Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)" outlining the processes for the renewal, discontinuation, and change of status of authorizations and export licenses for therapeutic products. This guidance is essential for ensuring compliance with regulatory requirements and maintaining the validity of authorizations for pharmaceutical products.

Renewal of Authorization: The process of extending the validity of an existing authorization for a therapeutic product beyond its initial term.

Discontinuation of Authorization: The process of officially ending the authorization of a therapeutic product.

Change of Status: Modifications to the status of a therapeutic product’s authorization, including changes from main authorization to export license or other status alterations.

This guidance document describes the rules that apply to the renewal or discontinuation of authorisation, how these rules are to be handled and the associated rights and obligations incumbent on authorisation holders.

This guidance document applies to authorisation renewals, to notifications or applications to discontinue authorisation for a medicinal product, dosage strength or pack size, and to applications for changes of status between main authorisations and export licences for human and veterinary medicinal products authorised by the regular or notification procedure or holding temporary authorisation.

Applications for the renewal of authorization must be submitted to Swissmedic at least six months before the current authorization expires. The application should include:

  • A completed application form

  • The current authorization certificate

  • Documentation of any changes made to the product since the last authorization

  • Evidence of ongoing compliance with regulatory requirements

The initial authorisation period for medical products is five years. Five years after the initial authorisation, a once-only application to extend the authorisation must be filed, Renewal is subject to ongoing compliance with the authorisation conditions, and once renewed, authorisation generally lasts for an unlimited time.

When a medicinal product receives temporary authorisation in response to an application for this purpose, or when an ex officio time-limit is necessary to protect the health of the patient, its initial duration can be less than five years. In these cases, authorisation is usually limited to two years.

For more detailed information, refer to the full guidance document available on the Swissmedic website: Renewal and Discontinuation of Authorization or Change of Status.


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