Adverse Drug Event Report
An encrypted adverse drug event (AE/ADR) report for Swissmedic pharmacovigilance. Covers patient demographics, suspected product details, event description, severity, outcome and reporter information. Compliant with HMG Art. 59, ICH E2A and WHO-UMC guidelines.
About this template
This template provides pharmaceutical companies, healthcare professionals and pharmacies with a structured adverse drug event (ADE/ADR) reporting form for Swissmedic pharmacovigilance obligations. It captures all elements required by Swissmedic's electronic reporting system: patient demographics (without name), suspected product details, event description and timeline, clinical severity grading, outcome, and reporter identification. All data is encrypted end-to-end.
What it collects
- Patient age group and gender (no name required)
- Suspected medicinal product — name, lot number, expiry date
- Event description and onset date
- Event severity classification (mild / moderate / severe / life-threatening / fatal)
- Clinical outcome at time of reporting
- Causality assessment (certain / probable / possible / unlikely)
- Concomitant medications and relevant medical history
- Reporter identification and professional category (HCP or consumer)
Swissmedic HMG Art. 59 reporting obligation
Holders of marketing authorisations and persons operating in the health care sector are obliged to report suspected adverse reactions to Swissmedic under Swiss Heilmittelgesetz (HMG) Article 59. Serious adverse events must be reported within 15 calendar days. Non-serious events must be reported within 90 days. This form supports both expedited and periodic reporting workflows.
How to use it
Use this template
Click 'Use template' to create a copy in your dashboard.
Add your company or site details
Update the form description with the MAH (Marketing Authorisation Holder) name and the reporting contact for Swissmedic.
Configure routing
Route submissions to your pharmacovigilance team inbox. Ensure the team has the decryption key.
Integrate with your safety database
Export encrypted responses and import into your validated safety database (Argus, ARISg, etc.) according to your data management procedure.
Pharmacovigilance obligations under Swiss HMG
Switzerland's Heilmittelgesetz (HMG) Article 59 establishes a comprehensive pharmacovigilance obligation for marketing authorisation holders. Any individual or company placing a medicinal product on the Swiss market must establish a pharmacovigilance system, maintain qualified personnel, and report suspected adverse reactions to Swissmedic. The European Union's Good Pharmacovigilance Practices (GVP) Module VI, which Swissmedic largely adopts, specifies the technical requirements for case reporting, including the minimum information required for a valid case.
A valid adverse event report requires at minimum: (1) an identifiable reporter, (2) an identifiable patient, (3) a suspected product, and (4) an adverse event. This template captures all four elements. Additional detail — causality assessment, medical history, concomitant medications — improves the signal-detection value of the report and should be included where available.
ICH E2A and WHO-UMC causality terminology
ICH E2A defines the minimum data elements for expedited case reports. The WHO-UMC causality assessment scale (certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable) is the standard terminology used by Swissmedic and international partners in the VigiBase signal detection network. Using standardised causality terminology maximises the value of your reports for international signal detection.
Reporter obligations: HCPs vs consumers
Healthcare professionals (HCPs) — physicians, pharmacists, nurses — have a professional and in some cases legal obligation to report suspected adverse reactions. In Switzerland, the HMG and cantonal professional regulations establish this duty. Consumer reports (from patients or caregivers) are equally valued by Swissmedic from a signal-detection perspective and should be encouraged by marketing authorisation holders through patient information materials.
Frequently asked questions
What is the difference between an adverse event and an adverse drug reaction?
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product, regardless of causality. An adverse drug reaction (ADR) is an AE for which a causal relationship between the drug and the event is at least reasonably possible. For spontaneous (post-marketing) reports, all events are assumed to have at least a possible causal relationship by default — the reporter does not need to establish causality to submit a valid report.
What constitutes a serious adverse event?
An adverse event is serious under ICH E2A if it: results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event that may jeopardise the patient. Serious adverse events must be reported to Swissmedic within 15 calendar days of the MAH becoming aware.
Can this form be used for clinical trial adverse event reporting?
This form is designed for spontaneous post-marketing adverse event reports. Clinical trial adverse events (including SUSARs) have different reporting requirements under HFG, ICH E6 and EU CT Regulation and should be reported through the designated clinical trial safety reporting pathway. Consult your CRO or sponsor safety team.