31 December 2021
Changes to the guidance document Temporary authorisation of human medicinal products HMV4
Should Swissmedic decide, in reviewing an authorisation application, that the data provided are not sufficient for an ordinary authorisation, it is permitted – on the assumption that it meets the criteria set forth in Article 18 TPLO – to issue an “ex officio” temporary authorisation.
For more information, see here.
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