Changes to the guidance document Temporary authorisation of human medicinal products

15. September 2023 – 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.