Changes to the guidance document Temporary authorisation of human medicinal products HMV4

31 décembre 2021 – 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.