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.
The scope of this guidance applies throughout the Authorisation division of Swissmedic for 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.
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Also, there were changes to the guidance document "Formal requirements HMV4 and the form Import of a medicinal product" according to Art. 14 (2) TPA (parallel import) HMV4.