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Vigilance-System

Reporting adverse reactions

Pharmacovigilance
Here you can find information and forms for reporting adverse drug reactions. The second form is for reporting adverse reactions to antidotes and antivenoms only.

Electronic reporting

ElViS

Companies

Forms

MU101_20_004d_FO UAW Antidota Antivenine (DOCX, 195 kB, 26.10.2022)

TAM-Vigilance

Veterinary medicinal product

Haemovigilance

Meldung Transfusionsreaktion (PDF, 1 MB, 14.10.2024)

Meldung schwerwiegendes Vorkommnis im Umgang mit labilen Blutprodukten (PDF, 603 kB, 22.11.2024)

Biovigilance on transplant products / gene therapy / genetically modified organisms

BW314_00_991e_FO Form Notification of a release into environment, transmission to a person/animal of an authorized GT/GMO (DOCX, 369 kB, 02.10.2023)

BW314_00_984e_MB Biovigilance (single notifications, PSURs) and quality defects relating to authorised ATMPs and other products (bacteriophages, etc.) and procedures (PDF, 1 MB, 01.10.2023)

Materiovigilance (Medical devices)

Reporting incidents and FSCAs (Field Safety Corrective Action)

Economic operators

Users

Clinical trials (cleared by Swissmedic)

Safety measures in clinical trials

Further information

Documents

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Pharmacovigilance

TAM-Vigilance

Materiovigilance

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