Reporting adverse drug reactions in Switzerland
Three routes lead to Swissmedic. Patients report voluntarily through an online form, healthcare professionals report as a legal duty through ElViS or a regional centre, and marketing authorisation holders report electronically only. Serious cases within 15 days, non-serious within 60.
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What is an adverse drug reaction?
An adverse drug reaction is a harmful and unintended response to a medicinal product where a link to its administration is at least possible. No proof of causality is needed: suspicion is enough. The definition also covers off-label use, overdose, abuse and medication errors.
Who has to report in Switzerland?
Two groups carry the duty: healthcare professionals who prescribe, dispense or administer medicines, and companies that manufacture or distribute ready-to-use medicinal products. The legal basis is Art. 59 TPA, with the detail in Art. 61 ff. TPO. Patients and their relatives may report but are not obliged to.
Which deadlines apply?
Swissmedic grades the deadlines by seriousness, not by who reports. Serious suspected cases go within 15 days, non-serious and previously unknown ones within 60 days. For medical devices the MedDO adopts the deadlines of Art. 87 EU MDR, which are as short as two days.
| Case | Who reports | Deadline | Channel |
|---|---|---|---|
| Serious adverse drug reaction | Professional, authorisation holder | 15 days | ElViS |
| Non-serious, previously unknown reaction | Professional, authorisation holder | 60 days | ElViS |
| Reaction reported by the person affected | Patient, relatives | No deadline | Online form |
| Quality defect with a health risk | Authorisation holder, professional | Without delay | Market surveillance |
| Device: serious public health threat | Manufacturer, CH-REP | 2 days | Economic operator form |
| Device: death, serious deterioration | Manufacturer, CH-REP | 10 days | Economic operator form |
| Device: other serious incidents | Manufacturer, CH-REP | 15 days | Economic operator form |
When does the clock start?
Day 0 is the day the minimum information first reaches any point in the company, including a sales representative, a call centre or a service provider. It is not the day the pharmacovigilance department hears about it. That distinction produces inspection findings with some regularity.
What counts as serious?
A reaction is serious if it is fatal or life threatening, requires or prolongs hospitalisation, leads to persistent disability, causes a congenital anomaly, or is judged medically significant to a comparable degree. The term describes the outcome, not the intensity: a severe headache is not serious, a quiet rise in liver enzymes that ends in hospital is.
- Death or a life threatening situation
- Hospitalisation or its prolongation
- Persistent or significant disability
- Congenital anomaly or birth defect
- A medically significant event that prevented one of the above
What does a report have to contain?
Swissmedic can only process a report that carries four minimum elements. If one is missing you have an enquiry rather than a report. In practice it pays to secure those four first and chase the detail afterwards in follow-up.
- An identifiable patient, at least with initials, age or sex.
- An identifiable medicinal product, ideally with product name, authorisation number and batch number.
- A described reaction with onset and course.
- An identifiable reporter with contact details for follow-up.
What happens after you report?
Swissmedic records the case in the national database, assesses it and forwards it to the WHO database VigiBase. Reports from healthcare professionals often pass first through a regional pharmacovigilance centre at a university hospital, which assesses them clinically and asks follow-up questions. Across many reports, signals emerge that lead to a change in the product information, a letter to professionals or, rarely, a market withdrawal.
Adverse reaction, quality defect or incident?
Three terms, three routes. An adverse drug reaction concerns how the product acted on a person. A quality defect concerns the product itself: discoloured tablets, a faulty container, wrong labelling. An incident concerns a medical device that malfunctioned. Choosing the wrong channel costs time but nothing final: Swissmedic routes it internally.
Frequently asked questions
Do I have to report as a patient?
No. For patients and relatives reporting is voluntary and carries no deadline. Only healthcare professionals and companies have a legal duty. Your report still matters, because it captures complaints that never come up in a consultation.
Can I report anonymously?
The reporter has to be identifiable to Swissmedic so that follow-up questions are possible. Your personal data is treated confidentially and held pseudonymised in the case database. You are not named to the marketing authorisation holder.
What if I am not sure the medicine caused it?
Report anyway. Causality does not have to be proven; suspicion is enough. Assessing causality is the job of Swissmedic and the regional centres, not of the person reporting.
Does a medication error count as a reportable reaction?
A medication error that caused a harmful reaction is reportable like any other serious adverse reaction. Errors without harm are handled as a quality or process matter, but they still matter to an authorisation holder's signal management.
Does the duty also cover complementary medicines and OTC products?
Yes. The duty under Art. 59 TPA covers every authorised medicinal product, including non-prescription products, herbal medicines and authorised homeopathic products.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.