PSUR requirements after authorisation

In the official decision issued for an application according to Art. 13 TPA, the marketing authorisation holder is also obliged to inform Swissmedic immediately and in full, of all conditions imposed by the reference authority concerning the medicinal product that have not yet been fulfilled, and to submit related applications. In Switzerland, the PSUR obligation applicable in the EU does not apply to all products. In such cases, the following general rule applies: the PSUR is a condition specific to Switzerland and as such is always stipulated explicitly under a separate point in the official decision (under “Conditions”). If this is not the case, there is no PSUR obligation, and no PSURs need to be submitted.