The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance, "Renewal, Discontinuation, and Status Change of Medicinal Product Authorization,s" detailing the procedures for the renewal, discontinuation, and status change of medicinal product authorizations in Switzerland. This document, effective 1 March 2025, provides regulatory clarity for pharmaceutical companies managing their product lifecycle under Swissmedic regulations.
This guidance applies to:
Renewals of regular and temporary authorizations.
Discontinuation of medicinal products, dosage strengths, and pack sizes.
Status changes between main authorization and export licenses.
Renewal of Medicinal Product Authorizations
A) Duration and Renewal Process
Medicinal products are initially authorized for five years.
A single renewal application is required before the expiration date.
Once renewed, authorization is typically valid indefinitely, unless specified otherwise.
Temporary authorizations (e.g., emergency approvals) are valid for two years and must be renewed separately.
B) Submission Timelines
Applications must be submitted between 12 months and 6 months before expiration.
If a renewal application is not received six months before expiry, the authorization will be automatically withdrawn.
Products under additional regulatory monitoring may have specific submission deadlines.
C) Required Documentation
Completed renewal application form
Updated product information (if applicable)
Justification for continued authorization
Confirmation of compliance with Swissmedic regulatory requirements
Status Change Between Main Authorization and Export License
Swissmedic allows conversion of a product’s status between:
Main Authorization → Export License (Product is no longer sold in Switzerland but remains authorized for export).
Export License → Main Authorization (Reintroducing a product into the Swiss market).
Key Differences:
Export licenses do not include approved product information or pack sizes.
Main authorizations require submission of full product documentation for approval.
Discontinuation of Authorization:
Authorisation holders may opt not to renew authorisation by notifying Swissmedic accordingly at the earliest one year before expiry of the authorisation
If the authorisation of a medicinal product expires, any pending administrative proceedings (concerning applications for variations, for example) will be dismissed.
Status Change:
Describes rules for Status change from main authorisation to export licence and vice versa
Specific Considerations:
Details particular requirements applicable to basic products and co-marketing medicinal products
Processing Time & Fees:
Processing time details can be found in the document
Fees are as per the Ordinance on the Fees charged by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic)
Renewals, discontinuations, and status changes will be published in the Swissmedic Journal in the month following approval. If a pediatric drug is discontinued, Swissmedic will make scientific data available to third parties for potential re-authorization.
By following the outlined procedures, companies can maintain compliance and prevent disruptions in market availability. 🔗 For complete details, refer to the official Swissmedic guidance: Swissmedic Renewal & Discontinuation Guidelines
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