In order to standardise practice, Swissmedic will in future publish both the proposed and approved indications in the Swiss Public Assessment Report. Swissmedic will assess the validity of companies’ claims of commercially confidential information according to the criteria published in the Guidance document SwissPAR.
01.07.2024
Swissmedic publishes both the proposed and approved indications in the Swiss Public Assessment Report (SwissPAR). The applicant may request that Swissmedic refrain from publishing the proposed indication insofar as this would conflict with justified confidentiality interests. To date, Swissmedic has not always assessed the validity of such claims stringently. Swissmedic is standardising its practice and in future will consistently assess and decide on applications for confidentiality of the proposed indication according to the criteria published in the “Commercially Confidential Information (CCI)” section of the Guidance document SwissPAR
Editorial changes have been made to the Guidance document SwissPAR in the interests of standardisation.
The new practice and the revised Guidance document SwissPAR come into effect on 1 July 2024.