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Swissmedic Guidance on Renewals, Variations & Extensions

On January 28, 2022 Swismedic released a list of guidances for different segments, check out the below important list of swiss medic guidances in this LINK

This guidance document explains the requirements pertaining to variations and extensions for human medicinal products. Annex 7 TPLRO (List of variations as per Arts. 21–24 TPO) provides a list of all variations of types IA/IAIN, IB and II and the extensions that are relevant for Switzerland and for which Swissmedic is responsible.

This guidance document applies to the Authorisation, Licensing and Market Surveillance divisions of Swissmedic for applications for a change and/or extension relating to human medicinal products received by Swissmedic from the effective date of the revised Therapeutic Products Act (TPA).

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 throughout the Authorisation division of Swissmedic 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 where such applications were received by Swissmedic from 1 January 2019 (date on which the revised TPA enters into force).


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