Glossary of Swiss pharmacovigilance
Forty terms used daily in Swiss vigilance work, from adverse drug reaction through day 0 to SUSAR. Each entry opens with a one-sentence definition and then gives the Swiss context: which authority, which deadline, which legal basis.
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- Adverse drug reaction (ADR)UAW / ADR
A harmful and unintended response to a medicinal product where a link to its administration is at least possible.
The term requires no proof of causality: suspicion is enough to report. It also covers reactions from off-label use, overdose, abuse and medication errors.
In Switzerland healthcare professionals and marketing authorisation holders have a reporting duty under Art. 59 TPA. Serious cases go to Swissmedic within 15 days, non-serious and previously unknown ones within 60 days.
- BASEC
The submission platform for applications to the Swiss ethics committees.
BASEC is used to file initial applications, amendments, safety reports and interim and final reports, and to document the history. The committee decides no later than 30 working days after completeness is confirmed.
The completeness check is where the clock stops: an incomplete dossier does not start the deadline. Missing language versions and the insurance certificate are the most frequent causes.
- Batch recallRecall
Withdrawing a specific batch from the market when a quality defect or a safety risk requires it.
The recall level follows the risk and ranges from informing wholesalers to a recall at patient level. Reconstructing where the batch was shipped is the time critical part.
Swissmedic publishes recalls and is informed beforehand. Recall effectiveness is checked through the return rate and documented.
- Clinical Trials Ordinance (ClinO)KlinV / OClin / OSRUm / ClinO
The ordinance on clinical trials in human research, SR 810.305, with the authorisation procedure and safety reporting.
ClinO governs risk categories A, B and C, the procedure before the ethics committee and Swissmedic, the deadlines, safety reporting including SUSARs, sponsor duties, and documentation and archiving.
Clinical trials with medical devices fall under the separate ClinO-MD. If you are categorising a protocol, read the category definitions first and the competence rules second.
- Corrective and preventive action (CAPA)CAPA
The corrective and preventive action that addresses a deviation at its root cause.
A CAPA consists of the immediate correction, the root cause analysis, the preventive measure, a due date, an owner and an effectiveness check. Without the effectiveness check it is not closed.
A deviation you found, analysed and fixed yourself reads in an inspection as a process under control. A deviation the inspector finds first is a system finding.
- Day 0
The calendar day on which the minimum information first reaches any point of the company or a contracted third party.
Day 0 is not the day the pharmacovigilance department receives the case. It covers the field force, the medical information inbox, the distributor's complaint hotline and every partner under an SDEA.
Setting day 0 wrongly is the most common substantive deadline breach and the first thing an inspection checks. The effective countermeasures are a 24 hour forwarding duty for every patient-facing function and recording the first contact in the case log.
- Direct healthcare professional communication (DHPC)DHPC
The letter agreed with the authority that informs healthcare professionals of a new safety risk.
A DHPC is triggered when a signal is confirmed and changing the product information alone would work too slowly. Content, recipients and timing are agreed with Swissmedic.
In Switzerland the mailing has to be planned in the languages concerned, alongside updating the professional and patient information. Distribution must be documented.
- Educational material
An additional risk minimisation measure in the form of information material for professionals or patients.
Educational material becomes a condition when the product information alone does not control a risk well enough: dosing cards, pre-treatment checklists, patient cards or pregnancy prevention programmes.
In Switzerland it has to be available in the language regions concerned and agreed with Swissmedic. Distribution and effectiveness must be documented, otherwise the measure is not evidenced in regulatory terms.
- ElViS
The Swissmedic electronic vigilance reporting portal, the entry point for all medicinal product vigilance reports.
Since 1 July 2021 Swissmedic accepts reports from marketing authorisation holders electronically only: by a gateway connection in ICH E2B(R3) format or through the ElViS portal. Paper and e-mail are not accepted from companies.
Access runs through the federal eIAM login. Healthcare professionals may use ElViS but are not obliged to, and otherwise report through a regional pharmacovigilance centre.
- EudraVigilance
The central EU system for collecting and analysing adverse reaction reports, operated by the EMA.
Switzerland does not participate in EudraVigilance. A report in EudraVigilance satisfies no Swiss duty, and access to EudraVigilance data does not replace Swiss case processing.
A global system therefore needs a defined branch: Swiss cases are identified, assessed against the Swiss product information and submitted separately through ElViS.
- Field safety corrective action (FSCA)FSCA
A corrective safety action in the field through which a manufacturer reduces the risk of a product already on the market.
Typical FSCAs are a recall, exchange, retrofit, software update, enhanced monitoring or changed instructions for use. As a rule the action has to be notified to Swissmedic before it is implemented in the market.
It is accompanied by a field safety notice to the affected users. Effectiveness has to be tracked and closure documented.
- Field safety notice (FSN)FSN
The customer letter that accompanies a field safety corrective action.
The FSN names the product, the affected serial or batch numbers, the risk in plain language, the action required and a contact point. It goes to every affected user and operator.
In Switzerland the FSN is needed in the language regions concerned. Evidence of who received it and who responded belongs to the documentation of the action.
- Follow-up
The targeted chase on a reported case, to fill in missing data and the outcome.
Follow-up is not a courtesy loop but the part of the process that makes a case assessable. The questions are specific: outcome, re-exposure, laboratory values, concomitant medication, alternative explanations.
At least two documented attempts are expected, with date, channel and the question asked, and more for a serious case with an unknown outcome. Follow-up that brings new relevant information triggers a follow-up report on the same deadline as the initial one.
- Good pharmacovigilance practices (GVP)GVP
The EU guidelines that describe, in modules, how pharmacovigilance is put into practice.
The GVP modules are not directly applicable law in Switzerland but are treated in practice as the state of the art. Building your system on GVP and adding the Swiss specifics puts you in a defensible position.
What has to be added is above all the Swiss roles and channels: RPPV instead of QPPV, ElViS instead of EudraVigilance, and the Swiss product information as the expectedness reference.
- Human Research Act (HRA)HFG / LRH / LRUm / HRA
The federal act on research involving human beings, SR 810.30, the framework act for clinical trials in Switzerland.
The HRA governs consent, protection of dignity and personality, data protection in research, the role of the ethics committees, risk categorisation, the registration duty, and liability and insurance.
It is made concrete in ordinances, in particular the Clinical Trials Ordinance (ClinO) for medicines and ClinO-MD for medical devices.
- ICH E2B(R3)
The international XML data standard for the electronic transmission of individual case reports.
E2B defines which fields a case report contains and how they are structured, from report identification through patient data to the assessment of outcome. Swissmedic works with version R3.
Anyone running a gateway connection has to meet the Swissmedic validation rules; a case that fails validation counts as not submitted and the deadline keeps running.
- ICH E2C(R2)
The ICH guideline that sets the structure and content of the periodic benefit-risk report.
E2C(R2) describes the chapter structure of the PBRER, from the worldwide authorisation status through exposure estimation and the data overview to the integrated benefit-risk analysis and the conclusions.
Swissmedic accepts reports in this format. If you reuse an EU report for Switzerland, add Swiss exposure, Swiss actions and the assessment against the Swiss product information.
- Individual case safety report (ICSR)ICSR
The structured electronic report of a single suspected case.
An ICSR bundles patient data, the suspect medication, the reaction, its course and the report source into a defined data model. The standard is ICH E2B(R3) and the terms are coded in MedDRA.
In Switzerland an ICSR is submitted to Swissmedic through ElViS, by gateway or through the portal. The submission acknowledgement is the proof that the deadline was met and belongs in the case file.
- Literature search
The systematic, documented search for published safety information on your own products.
The search covers databases such as Embase and Medline plus the Swiss trade press, with product-specific search strings, a defined frequency and documented hit assessment. The deliverable is the reproducible search strategy, not the hit list.
A literature case with an identifiable patient in Switzerland is handled like a spontaneous case, with day 0 on the day you became aware of the publication.
- Marketing authorisation holderMAH
The legal entity in whose name a medicine is authorised in Switzerland and which answers for its safety.
The authorisation holder carries the pharmacovigilance duties: the system, the RPPV, reports, PSURs, signal management and actions. These can be outsourced operationally; the responsibility stays.
A Swiss registered office is not required for every authorisation, but a working Swiss pharmacovigilance system with a reachable RPPV is.
- Materiovigilance
Post-market surveillance of medical devices, with a duty to report incidents and corrective actions.
Professionals and operators report serious incidents without delay to the manufacturer or its Swiss authorised representative and to Swissmedic. Manufacturers and representatives report as economic operators within two, ten or fifteen days.
The device involved has to be quarantined unchanged: not cleaned, not repaired, not reprocessed, not discarded. Without the device, root cause analysis is usually impossible.
- MedDRA
The Medical Dictionary for Regulatory Activities, used to code reactions and diagnoses.
MedDRA is hierarchical, from the lowest level term through the preferred term up to the system organ class. Coding makes cases comparable and is what allows a signal to emerge from individual reports.
Missing or coarse coding is a common quality defect: a reaction captured as free text is invisible to every analysis. MedDRA is updated twice a year and the version in use has to be documented.
- Medical Devices Ordinance (MedDO)MepV / ODim / ODmed / MedDO
The ordinance on medical devices, SR 812.213, with materiovigilance in Art. 66.
The MedDO is largely aligned with EU Regulation 2017/745 and, for incident reporting deadlines, refers to its Art. 87: two, ten and fifteen days depending on severity.
It also governs the Swiss authorised representative, the duties of importers and distributors, and registration. For in vitro diagnostics the parallel IvDO applies, referring to EU Regulation 2017/746.
- Medicinal Products Ordinance (TPO)VAM / OMéd / OM / TPO
The ordinance on medicinal products, SR 812.212.21, with the pharmacovigilance implementing provisions in Art. 61 ff.
The TPO makes the TPA reporting duty concrete: which cases have to be reported, within what deadline, in what form, who the qualified person responsible for pharmacovigilance is and which periodic reports are required.
Anyone building Swiss pharmacovigilance reads Art. 61 ff. TPO first and then the Swissmedic guidance documents that describe implementation in detail.
- Minimum information
The four elements without which a case report is not valid: patient, product, reaction, reporter.
You need an identifiable patient, an identifiable medicinal product, a described reaction and an identifiable reporter. If one is missing you have an enquiry, not a report.
Receipt of the minimum information sets day 0 and starts the clock. Further detail is chased in follow-up, which does not extend the deadline.
- Periodic benefit-risk evaluation report (PBRER)PBRER
The content format of the periodic safety report under ICH E2C(R2), combining benefit and risk in one document.
The PBRER replaced the older PSUR structure and explicitly requires an integrated benefit-risk appraisal rather than a case collection. It carries cumulative and interval data, a signal overview and an assessment of how well risk minimisation is working.
In day-to-day use PSUR and PBRER are treated as synonyms: PSUR names the regulatory duty, PBRER the format in which it is met.
- Periodic safety update report (PSUR)PSUR
The periodic safety report in which the authorisation holder re-evaluates a product's benefit-risk balance.
A PSUR summarises the safety data of an interval: worldwide exposure, individual cases, literature, studies, signals, regulatory actions and the resulting benefit-risk evaluation. The content format is the PBRER under ICH E2C(R2).
Swissmedic sets the submission interval per authorisation. Expectedness is judged against the Swiss-approved product information, which is why an EU PSUR normally needs a Swiss annex.
- Pharmacovigilance inspectionPV inspection
Swissmedic's examination of an authorisation holder's pharmacovigilance system.
The examination tests whether the described system matches the one actually run. The entry point is the PSMF; the substance is sampling from the case log across twelve to twenty-four months, traced back to the source document.
Findings are graded and worked off through CAPA. A company that knows, analysed and corrected its own deadline breaches fares far better than one presenting clean statistics with no deviation process.
- Pharmacovigilance system master file (PSMF)PSMF
The central description of an authorisation holder's pharmacovigilance system.
The PSMF describes the organisation, roles, processes, databases, service providers and contracts, and carries a change log. It is the document an inspection starts from.
In Switzerland the system has to be described and the description kept current, even though the PSMF itself is an EU construct. A Swiss annex covering the RPPV, ElViS access, an SDEA overview and the Swiss SOPs has proved its worth in inspections.
- Product information for professionalsFachinformation
The Swissmedic-approved product information for healthcare professionals, the reference for whether a reaction is expected.
Expectedness is always assessed against the Swiss-approved product information, not the EU SmPC and not the company core safety information. A reaction listed in the EU can be unexpected in Switzerland.
It follows that a case's reportability and deadline depend on the Swiss text version. The current version therefore belongs in every case assessment, not only in the authorisation dossier.
- Qualified person for pharmacovigilance (QPPV)QPPV
The responsible person for pharmacovigilance required in the EU, resident and operating in the Union.
The QPPV is registered in EudraVigilance and named in the pharmacovigilance system master file. Their remit stops at the EU border: Switzerland needs a separately named RPPV.
In practice it is often the same individual. That is acceptable as long as the Swiss role is documented in its own right, notified to Swissmedic and reachable during Swiss business hours.
- Qualified person responsible for pharmacovigilance (RPPV)RPPV
The person named by the marketing authorisation holder who is responsible for the Swiss pharmacovigilance system.
The RPPV must demonstrate extensive pharmacovigilance knowledge and be reachable during Swiss business hours, with on-call cover beyond them. Residence in Switzerland is not required, but the details must be given to Swissmedic on request.
The role covers oversight of the system, case release, signing the PSUR, signal management decisions and acting as the contact point in an inspection. A documented deputy is mandatory and its absence is the single most common finding.
- Quality defect
A defect in the product itself: discoloured tablets, a faulty container, wrong labelling or contamination.
A quality defect concerns the medicine, not its effect on a person, so it runs through market surveillance rather than pharmacovigilance. Where health is at risk, it is reported without delay.
The affected batch is quarantined, a retention sample kept and the distribution data pulled together. The qualified person decides on the recall and its level in agreement with Swissmedic.
- Regional pharmacovigilance centreRegional PV centre
One of five centres attached to university hospitals that process and clinically assess reports from healthcare professionals.
The centres take reports, assess causality and relevance, ask follow-up questions and advise professionals on stopping, switching or re-exposure in an individual case. The assessed cases go on to Swissmedic.
For a healthcare professional the centre is the better address when a clinical assessment is needed; ElViS is the direct route when the case is fully documented.
- Risk categories A, B and CCategories A, B, C
The classification of clinical trials by hazard potential, which decides which authorisations you need.
For category A the approval of the competent cantonal ethics committee is enough. For categories B and C under ClinO, and category C under ClinO-MD, a Swissmedic authorisation is added.
Hazard potential rises from A to C. A wrong categorisation costs a resubmission and therefore weeks, which is why it is settled before the dossier is assembled.
- Risk management plan (RMP)RMP
The plan describing a medicine's known and potential risks and the measures that address them.
An RMP holds the safety profile, the important identified and potential risks, missing information, the pharmacovigilance plan and the risk minimisation measures, split into routine and additional ones.
For Switzerland an EU RMP is adapted: Swiss contact details, the wording of the Swiss product information, language versions of educational material and the actual Swiss distribution set-up. Measure effectiveness has to be assessed and reported in the PSUR.
- Safety data exchange agreement (SDEA)SDEA
The contract that governs the exchange of safety data between two partners.
An SDEA defines the scope, the day 0 definition, exchange deadlines, formats, language, responsibility for literature and PSURs, signal exchange, audit rights, escalation and data handover on termination. The internal deadlines have to be shorter than the regulatory ones.
You need an SDEA with licensors and licensees, distributors, service providers, co-marketing partners and, for a medical device, with the Swiss authorised representative. Without periodic case count reconciliation it is a paper control.
- Serious
A classification by outcome: death, life threatening, hospitalisation, persistent disability or congenital anomaly.
Serious describes the consequence, not the intensity. A severe headache is not serious; a largely asymptomatic rise in liver enzymes that leads to hospitalisation is. A further category covers medically significant events of comparable importance.
The classification drives the deadline: serious means 15 days. It is justified in the case file and is a frequent inspection checkpoint, because a lenient classification effectively extends the deadline.
- Signal
Information that makes a new or changed association between a medicine and an event look possible.
A signal is not yet knowledge but a hypothesis that has to be tested. Sources are your own cases, literature, studies, actions by other authorities, databases such as VigiBase and quality trends.
A single well documented case can be a signal if the reaction is characteristic. Swiss case numbers are small, so qualitative review and alignment with the global signal process matter more than statistics.
- Signal management
The documented cycle of signal detection, validation, prioritisation, assessment, decision and tracking.
Every step needs an owner, a date and a reasoning a third party can follow. A signal is either refuted, kept under observation or confirmed; a confirmed signal leads to an action.
An inspection does not examine your method but your traceability: can someone else understand from the file why the decision went the way it did? The minute is the deliverable, not the database query.
- Sponsor
The person or institution that takes responsibility for initiating, managing and financing a clinical trial.
The sponsor answers for the protocol, GCP compliance, monitoring, safety reporting, amendments, insurance, archiving and the end-of-trial notification. In investigator-initiated studies this is often the hospital or the investigator.
A sponsor established abroad needs a representative in Switzerland so that the authority and the ethics committee have a reachable contact.
- Standard operating procedure (SOP)SOP
The written instruction that binds a pharmacovigilance process.
An SOP states the purpose, scope, responsibilities, the process with its deadlines and the records to be produced. Without a date, a version and an approval it is regulatorily worthless.
A Swiss system needs at least case processing, deadline monitoring, literature searching, signal management, PSURs, training, deviations and CAPA, and the ElViS outage procedure.
- Suspected unexpected serious adverse reaction (SUSAR)SUSAR
A suspected, unexpected and serious adverse reaction occurring in a clinical trial.
Unexpected means not described, or not described at this severity, in the investigator's brochure. All three attributes, suspected, unexpected and serious, have to be present together.
The sponsor reports fatal or life threatening SUSARs within 7 days and all others within 15 days, to Swissmedic and to the ethics committee. The clock runs over the weekend too.
- Swiss authorised representative (CH-REP)CH-REP
The Switzerland-based representative of a foreign medical device manufacturer towards Swissmedic.
The CH-REP is the authority's contact point, keeps the technical documentation available and is built into the vigilance processes. It is a regulatory role, not a sales function.
In practice materiovigilance often fails at this interface: without a contractually defined reporting chain and access to the incident data, the CH-REP cannot meet its duties.
- swissethics
The umbrella organisation of the Swiss ethics committees for research on human beings.
swissethics coordinates the seven cantonal ethics committees, publishes the templates for applications, consent forms and notifications, and runs the BASEC submission platform.
The approval itself is not granted by swissethics but by the competent cantonal committee. In multicentre studies one committee leads the procedure and the involved committees are consulted.
- Swissmedic
The Swiss Agency for Therapeutic Products, the national authorisation and surveillance authority.
Swissmedic grants marketing authorisations, runs market surveillance, operates pharmacovigilance and materiovigilance, inspects establishments and authorises clinical trials in categories B and C.
Reimbursement through basic health insurance and the Specialities List are not Swissmedic matters but the responsibility of the Federal Office of Public Health. The two procedures run separately, with their own deadlines.
- Therapeutic Products Act (TPA)HMG / LPTh / LATer / TPA
The federal act on medicinal products and medical devices, SR 812.21, the basis of Swiss therapeutic products law.
Art. 59 TPA establishes the duty to report adverse reactions and quality defects. The act also governs authorisation, manufacture, distribution, advertising and market surveillance.
The implementing provisions sit in the ordinances, in particular the TPO for medicines and the MedDO for devices. If you are looking for a deadline, it is in the ordinance, not the act.
- Tox Info Suisse145
The national poisons advice centre, reachable around the clock on 145.
For poisoning, accidental ingestion or overdose, Tox Info Suisse advises the public and professionals immediately and free of charge. In a life threatening emergency call 144.
A report to Swissmedic is a safety report for market surveillance, not treatment. The two do not exclude each other: treat first, report afterwards.
- Training
The documented evidence that every patient-facing function knows its pharmacovigilance duties.
Training is not only for pharmacovigilance staff: it covers the field force, medical information, marketing, quality, regulatory and management. The minimum content is what a report is, how to recognise one, forward it inside 24 hours, and to whom.
The evidence is dated attendance lists, a content outline and a repeat on a defined cadence. An untrained field force is the classic route by which day 0 gets lost.
- Trend report
The report of a statistically significant increase in non-serious incidents or expected reactions.
Individually the events would not be reportable; in aggregate they are. The manufacturer has to define thresholds in advance and document the analysis so it can be followed.
Without a defined threshold there is effectively no trend report, because nobody can establish when the trend occurred. That is precisely what a vigilance inspection asks about.
- VigiBase
The global database of individual case reports, maintained by the WHO Collaborating Centre in Uppsala.
Swissmedic forwards Swiss reports to VigiBase in pseudonymised form. Swiss cases therefore feed international signal detection even though Switzerland does not take part in EudraVigilance.
For authorisation holders VigiBase is a source for signal management, not a reporting route: the Swiss duty is met through ElViS only.
Not sure what applies to your product?
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Frequently asked questions
What is the difference between an RPPV and a QPPV?
The RPPV is the qualified person responsible for pharmacovigilance under Swiss law; the QPPV is the equivalent role in the EU. Switzerland is not part of EudraVigilance, so the Swiss role has to be named, documented and reachable during Swiss business hours, even where it is the same individual in practice.
What does day 0 mean?
Day 0 is the calendar day on which the minimum information about a case first reaches any point in the company or a service provider, including the field force or a call centre. The 15 and 60 day deadlines run from that day.
Where do I find the legal basis for these terms?
The reporting duty sits in Art. 59 TPA, the detail in Art. 61 ff. TPO, materiovigilance in Art. 66 MedDO, and clinical trials in the HRA and ClinO. Each entry links the original source on fedlex.admin.ch or swissmedic.ch.
Does an EU definition apply automatically in Switzerland?
The definitions largely coincide in substance because they rest on ICH standards. The roles, channels and reference documents differ: ElViS instead of EudraVigilance, RPPV instead of QPPV, and the Swiss product information instead of the EU SmPC as the expectedness reference.
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.