FAQs: General Pharmacovigilance

In the special case that a report of serious and/or so far unknown adverse effects includes both medicinal products and foodstuffs or cosmetic products as suspect products, it is nevertheless subject to reporting and must primarily be forwarded to Swissmedic.

* _{Complementary and herbal medicines are medicinal products. They are subject to the Therapeutic Products Act and are the responsibility of Swissmedic.
Further information: Herbal medicinal product (swissmedic.ch), Lists and directories (swissmedic.ch)}

**_{Foodstuffs are regulated in food legislation. Foodstuffs include, among others, nutritional supplements and novel foods (such as cañihua and protein extracts from insects), etc. 
Further information: Focus on food [available in German, French and Italian] (admin.ch)}

*** _{Cosmetic products (cosmetics) are also subject to food legislation. These include perfuming products and products used to cleanse and care for skin, hair, teeth and mucous membranes.
Further information: Cosmetics [available in German, French and Italian] (admin.ch).}

Additional information: Questions on delimitation (swissmedic.ch).

Last updated on: 03.10.2023

Article 59 of the Therapeutic Products Act (TPA) requires the manufacturer of therapeutic products or the distributor of ready-to-use therapeutic products to ensure that a reporting system is in place. This means, among other things, that the marketing authorisation holder or the manufacturer must designate a qualified person who is responsible for complying with reporting duties with respect to adverse drug effects and must inform Swissmedic of this person's name on request. Qualified means that the person responsible for PV (QPPV) has very good knowledge of pharmacovigilance and can produce the corresponding documentation / certificates on request. This person does not necessarily have to belong to the company, but his or her responsibilities must be set out in writing. The QPPV does not necessarily have to reside in Switzerland, but his or her name and address must be notified to Swissmedic on request.

AMBV Art. 12; VAM Art. 65

Last updated on: 01.01.2019

The person responsible for PV, or a deputy, must be contactable at least during business hours on Swiss working days.

Outside these times, it is recommended that the marketing authorisation holder organise an on-call service to ensure that a suitably qualified person is reachable at all times in emergencies. For example, this could be a toxicology information service or other appropriate information source.

Last updated on: 17.02.2016

The duty to report ADRs from Liechtenstein is governed by the authorisation status of a medicinal product.

The market in Liechtenstein is covered by the Swissmedic monitoring network under the terms of the Customs Treaty. Reports of ADRs involving medicinal products that are authorised in Switzerland and may be marketed in Liechtenstein under the terms of the Customs Treaty must be reported to Swissmedic. Medicinal products authorised in the EEA are covered by the European monitoring system. Adverse drug reactions and quality defects involving medicinal products authorised in the territory covered by the Agreement with Austria must be reported to the Ministry of Health in Austria.

http://www.llv.li/#/11134/arzneimitteluberwachung

http://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20006977

Last updated on: 01.01.2021

Art. 59 TPA requires all adverse drug reactions (ADRs) involving therapeutic products not authorised in Switzerland and with special authorisation to be reported to the Safety of Medicines Department at Swissmedic. The same criteria apply as for authorised medicinal products: all serious adverse reactions and all unknown non-serious adverse reactions must be reported (Art. 61 TPO). Only adverse drug reactions should be reported and not simply any adverse events. In other words, the doctor has assumed a causal connection between the event and use of the therapeutic product.

The reference document is the "Summary of Product Characteristics" (SPC) or the "Investigator’s Brochure" (IB) (if the product is not yet authorised worldwide).

The duty to report to Swissmedic falls on the treating doctor and on the company that is made aware of the ADR.

Last updated on: 01.01.2021

Lack of efficacy in itself does not have to be reported in Switzerland. However, Swissmedic recommends that all cases of lack of efficacy should be reported, particularly if clinically relevant complications are likely to ensue (e.g. in the case of vaccines, contraceptives, antibiotics or therapeutic products used to treat life-threatening conditions). All reported cases are entered in the national database and subsequently forwarded to the WHO database.

Clusters of cases involving lack of efficacy must be reported in accordance with Art. 59 TPA.

Last updated on: 14.01.2015

Off-label use in itself does not have to be reported. However, if these cases are reported to Swissmedic, they are entered in the national database. If an ADR occurs, it must be reported under the terms of Art. 59 TPA.

Last updated on: 14.01.2015

Cases of medication error, overdose, misuse and occupational or accidental exposure without additional adverse drug reactions (ADRs) do not have to be reported individually in Switzerland. However, if these cases are reported to Swissmedic, they are entered in the national database. Cases with additional ADRs must be reported individually in accordance with Art. 59 TPA.

The manufacturer or authorisation holder must provide notification of signals associated with these incidents in a report:

A company should state not only its own therapeutic product as suspect but also all the therapeutic products stated by the primary reported as being suspect or that are classified as suspect by the company.

Last updated on: 14.01.2015

Companies generally receive reports submitted to Swissmedic by healthcare professionals (HCPs) and consumers in cases where the company's medicinal products are classified as suspect. If only the active substance of the suspect medication is known, the case is sent only to the company, provided just a single authorisation holder exists for this active substance.

If Swissmedic receives a report from a company in which the medicinal product of another company is also classified as co-suspect, Swissmedic does not send this report to the second company.

Last updated on: 01.01.2021

Swissmedic is receiving a growing number of enquiries from companies about single case reports. These enquiries usually come from head office and are passed on unfiltered to Swissmedic by the company's Swiss branch. Many of these enquiries are irrelevant for medical evaluation of the case, or the information is already contained in the report sent to the company. These enquiries are not answered by Swissmedic.

However, in individual cases, Swissmedic continues to answer or process justified enquiries about unclear information, or additional information required to evaluate the case.

Last updated on: 01.01.2021

Questionnaires / information sheets from companies are only forwarded to the primary reporter for further investigation or completion if a written enhanced PV agreement has been concluded with Swissmedic.

Last updated on: 01.01.2021

The medical assessment of individual case reports improves report quality and is important for early detection of safety signals. Therefore, Swissmedic expects individual case reports from pharmaceutical companies to include a medical assessment containing the following information (see Table 1):

1. Expectedness of the adverse drug reaction (ADR)
   The following information is required for all reported ADRs: details regarding the “labelledness” in the Swiss Product Information (PI) for healthcare professionals or, in the case of ADRs not described there, additional information on the “listedness” in the Company Core Safety Information (CCSI).
   In addition, for “serious and unlabelled” ADRs: literature findings, class effects, similar cases in the database, etc.
2. Assessment of causality
   This should be provided for serious ADRs. It should take into account factors such as temporal association, information on dechallenge and rechallenge and alternative causes. An assessment as “unrelated” or “not assessable” is only justifiable based on plausible and comprehensible arguments. In this respect, an “implied causality” should be assumed for spontaneous reports.
3. Need for risk-minimising measures (including signal evaluation).
   The need for risk-minimising measures should be discussed for serious ADRs that are not labelled in the Swiss Product Information for healthcare professionals (serious/unlabelled).

Swissmedic recommends entering the medical assessment in the “Sender’s comment” field.

References
TPA Art. 58,59
TPO Art. 61,65,66
International Guidelines on Good Case Management Practice (EMA Module VI, CIOMS V, ICH E2D)

Last updated on: 20.09.2023

Narratives must be provided for all serious and non-serious unexpected cases. The narrative should contain all relevant information about the case and should serve as a standalone “medical story”. Follow-up information should be clearly identified as such and overwriting the initial narrative must be avoided.

International Guidelines on Good Case Management Practice (EMA Module VI, CIOMS V, ICH E2D).

Last updated on: 16.06.2015

Follow-up information does not need to be requested for non-serious expected cases provided the minimum criteria are known. In all other cases, at least two requests for follow-up information should be made at an interval of not more than four weeks if relevant information for assessing the case is missing. In the event of death or life-threatening situations, the first request should be made within the first 24 hours after the case report has become known. Follow-up requirements should be documented.

Last updated on: 23.04.2020

The current Clinical Trials Ordinance stipulates that ADRs that occur in the course of a Category A study (one that does not require approval from Swissmedic) must be reported to the Safety of Medicines Department at Swissmedic in accordance with the provisions of Art. 59 TPO (Art. 41 para. 4 ClinO). The reporting duty applies only to the sponsor and company, not to the investigator.

In other words, companies and sponsors are required to report all ADRs to Swissmedic within the reporting timelines of the spontaneous reporting system (Art. 59 TPO, as fleshed out by Art. 61 ff TPO). Since non-serious ADRs are generally recorded by the investigator only in the CRF and passed on to the sponsor at the end of the study, these can be sent to Swissmedic as a single report at the end of the study. If the sponsor or company becomes aware of them before the end of the study, they must be reported to Swissmedic sooner (i.e. within the period of the reporting obligation).

Last updated on: 01.01.2019

In Category A Investigator-Initiated Trials, the Sponsor-Investigator is subject to notification requirements under Art. 41 para. 4 of the Clinical Trials Ordinance (ClinO) in conjunction with Art. 59 of the Therapeutic Products Act (TPA). The Sponsor-Investigator is obligated to ensure that Swissmedic is notified of all serious expected or unexpected adverse drug reactions (ADRs) within 15 days and of all non-serious unexpected ADRs within 60 days.

Notifications should be submitted via the ElViS reporting platform. The following should be entered in the “Other comments” free text field: Cat A study, #name of study#.

From Swissmedic's perspective, the term “SUSAR” (suspected unexpected serious adverse reaction) is only used for Category B and C studies and not in connection with ADRs after marketing authorisation. Notification of suspected fatal or life-threatening unexpected ADRs in Category A studies to Swissmedic within 15 days is therefore acceptable (see Art. 41 para. 4 ClinO, Art. 59 para. 1–3 TPA and Art. 62 para. 1 let. a TPO). 

Last updated on: 09.12.2024