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19. Can i submit an effective RMP upgrade and additionally my PSUR?

This can end in having to fill in a large number of groups of monitored alter product information into even more load out of taking translations. And that MAHs can look at the substitute for focus on the advised amendments to help you SmPC and plan leaflet. Such instance, precisely the revised components of the fresh SmPC and you can package leaflet is always to be provided when you look at the track alter along with English language beneath the Eu local appendix.

Where in actuality the suggested change commonly in accordance with the studies recorded inside PSUR, such are not thought and you may a difference would have to getting submitted since the suitable to your relevant federal skilled expert.

However if no transform for the device recommendations are being suggested as part of the PSUR, the fresh new MAH cannot become people tool suggestions from inside the European union local appendix.