Source: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/marktueberwachung/pharmacovigilance/haeufige-fragen-und-antworten/haeufige-fragen-und-antworten--allgemeine-pharmakovigilanz.html
Timestamp: 2019-11-22 09:32:55
Document Index: 42668241

Matched Legal Cases: ['Art. 59', 'Art. 61', 'Art. 59', 'Art. 59', 'Art. 58', 'Art. 61', 'Art. 59', 'Art. 59', 'Art. 59', 'Art. 41', 'Art. 59', 'Art. 61']

FAQs: General Pharmacovigilance
What reporting duties do companies have in Switzerland?
The «qualified person responsible for pharmacovigilance» in Switzerland: What conditions apply?
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.
What rules apply in Switzerland to the contactability of the person responsible for pharmacovigilance (PV)?
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
What regulations apply when reporting adverse drug effects from Liechtenstein?
The duty to report ADRs from Liechtenstein is governed by the registration status of a therapeutic product.
The market in Liechtenstein is covered by the Swissmedic monitoring network under the terms of the Customs Treaty. Reports of ADRs involving therapeutic products that are registered in Switzerland and may be marketed in Liechtenstein under the terms of the Customs Treaty must be reported to a regional pharmacovigilance centre (RPVC) in Switzerland (healthcare professionals) or to Swissmedic (companies). Therapeutic products registered in the EEA are covered by the European monitoring system. Adverse drug effects and quality defects involving therapeutic products registered in the territory covered by the Agreement with Austria must be reported to the Ministry of Health in Austria.
Last updated on: 14.01.2015
What reporting duties apply to a therapeutic product not registered in Switzerland for which a doctor has obtained special authorisation in individual cases?
Art. 59 TPA requires all ADRs involving therapeutic products not registered in Switzerland and with special authorisation to be reported to the Safety of Medicines Department at Swissmedic. The same criteria apply as for registered therapeutic products: all serious adverse effects and all unknown adverse effects must be reported (Art. 61 VAM). No adverse events should be reported – only adverse drug reactions. This means that the doctor assumes a causal connection between the event and use of the therapeutic product.
The reference document is the SPC or IB (if the product does not yet have marketing authorisation worldwide).
The reporting duty falls on the attending physician (to a regional pharmacovigilance centre, RPVC) and on the company that is made aware of the ADR (to Swissmedic).
When does lack of efficacy / loss of drug effect / drug ineffective have to be reported as a single report?
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.
Does off-label use have to be reported in Switzerland?
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.
Which therapeutic products have to be reported / stated as suspect?
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.
When does Swissmedic pass on reports to companies?
Companies generally receive reports submitted to Swissmedic by HCPs and consumers via the regional pharmacovigilance centres (RPVC) and in which the company's therapeutic products are classified as suspect. If only the active substance of the suspect medication is known, the case is generally only sent to the company that holds the first marketing authorisation.
If Swissmedic receives a report from a company in which the therapeutic product of another company is also classified as co-suspect, Swissmedic does not send this report to the second company.
When does Swissmedic pass on enquiries from companies about reports from the Regional Pharmacovigilance Centres (RPVC)?
Swissmedic is receiving a growing number of enquiries from companies about single case reports from the RPVC. 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 or passed on by Swissmedic.
However, in individual cases, Swissmedic continues to pass justified enquiries about unclear information, or additional information required to evaluate the case on to the RPVC for processing or reply.
When does Swissmedic pass on questionnaires / information sheets from the companies to the primary reporters?
Questionnaires / information sheets from companies are only passed on to the regional pharmacovigilance centres (RPVC) for further investigation with the primary reporter (healthcare professional) or for completion if a written enhanced PV agreement has been concluded with Swissmedic.
For details please refer to the leaflet on enhanced Pharmacovigilance
What requirements does Swissmedic expect the medical assessment of individual case reports to fulfil?
Medical assessment of individual case reports improves report quality and is an important tool in the early detection of signals. Swissmedic therefore expects all individual case reports submitted by pharmaceutical companies to include a medical assessment containing the following information:
Level of awareness of the ADR
Details relating to the labelledness in the Swiss Information for healthcare professionals or, if the adverse drug reaction is not described in the Information for healthcare professionals, additional details of the listedness in the Core Company Data Sheet (CCDS), findings from the literature, class effects, similar cases in the database, etc.
This should take into account factors such as chronological correlation, information on dechallenge and rechallenge and alternative causes. An assessment of unrelated or not assessable is only justified if a plausible and verifiable explanation can be provided (e.g. unrelated if the adverse event occurred before the suspected medicinal product was administered). An inadequate data situation or alternative explanations are unsuitable explanations because a causal relationship with the suspected medicinal product cannot be ruled out with sufficient certainty. Implied causality should instead be assumed for spontaneous reports, and causality should consequently be rated as related or possible.
3. Need for risk minimising measures (including signal evaluation)
Swissmedic recommends entering this information in the «Sender's comment» field.
TPA Art. 58,59
TPO Art. 61,65,66
International Guidelines on Good Case Management Practice (EMA Module VI, CIOMS V, ICH E2D)
What should be remembered when writing case narratives?
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
When should follow-up information be requested?
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 requests should be documented.
Information sheet regarding «Drug exposure during pregnancy» and «Parent-Child reports»:
Information sheet regarding reports on adverse events following immunisation (AEFI):
How must ADRs from registers, patient programmes, cohort studies and other forms of data compilation be reported? Who is required to report them?
Art. 59 of the Therapeutic Products Act states that the healthcare professional who prescribes, treats or dispenses and the manufacturer / distributor of a therapeutic product have a duty to report. This means that only these healthcare professionals are required to report observed ADRs, and not a society / host organisation / patient advocacy organisation that compiles data. However, as soon as a company becomes aware of ADRs observed under one of these programmes, it has a duty to report them under Art. 59 TPA. Divergent contractual arrangements do not release the person required to report from their statutory reporting obligation. When reporting ADRs, care must be taken to ensure that the nature of the data compilation is specified on the backing form.
Last updated on: 30.09.2015
How do ADRs from a Category A study have to be reported?
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).
https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/marktueberwachung/pharmacovigilance/haeufige-fragen-und-antworten/haeufige-fragen-und-antworten--allgemeine-pharmakovigilanz.html