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MU101_20_001e_MB Guidance for Industry on the electronic exchange of ICSRs in E2B(R2) format through PV Gateway (PDF, 596 kB, 16.08.2024)
MU101_20_832e_MB Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway (PDF, 564 kB, 04.09.2024)
MU101_20_003e_MB Guidance for Industry Electronic exchange of ICSRs through ElViS (PDF, 1021 kB, 01.07.2021)
MU101_20_004e_MB Drug Safety Reporting Duties in Switzerland (PDF, 149 kB, 01.07.2021)
Drug exposure during pregnancy and «Parent-Child reports» from Switzerland – instructions / recommendations of Swissmedic (PDF, 135 kB, 10.05.2021)
General instructions / recommendations for submission of adverse events following immunisation (AEFI) (PDF, 73 kB, 14.01.2015)
Enhanced Pharmacovigilance FAQ
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