Swissmedic Vigilance News
Edition 31 – November 2023
Edition 31 – November 2023
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Update to the guidance document<br />
“RMP ICH E2E Information submission HMP”<br />
The guidance document “RMP ICH E2E Information<br />
for submission HMP” has been fully revised. The<br />
most important change concerns the obligation<br />
to submit RMPs, which now only applies to first authorisation<br />
applications for new active substances<br />
and their indication extensions.<br />
There is no RMP obligation for known active substances<br />
without/with innovation or for biosimilars.<br />
Other changes include clarifications regarding the<br />
submission of RMP updates and concerning the<br />
implementation of the RMP, as well as additional<br />
risk-minimisation measures.<br />
The changes take effect on 1 November 2023.<br />
Guidance document RMP / ICH E2E –<br />
Information for submission of RMP HMP<br />
<strong>Swissmedic</strong> <strong>Vigilance</strong> <strong>News</strong> | Edition 31 – November 2023<br />
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