15 September 2023
Changes to the guidance document Temporary authorisation of human medicinal products
Swissmedic published its clarification regarding authorised medicinal products, harmonised deadlines for applications before expiry of temporary authorisation and changes to terminology with effect from 15 September 2023. Now, for example, a uniform deadline of a maximum of 90 calendar days before the temporary authorisation expires applies to removal of the conditions relating to temporary authorisation, extension of the temporary authorisation or waiver of a temporary authorisation.
For more information, see here.
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