Company signals are evaluated in-house by the marketing authorisation holder without the involvement of an authority. By contrast, signals from authorities are signals evaluated by (foreign) authorities.
As soon as a company signal is also evaluated by an authority, it is considered to be a signal from an authority and the corresponding requirements and time limits apply.
The reporting obligation exists from the date the application for authorisation is submitted until the expiry date of the last batch supplied in Switzerland.
Swissmedic should be informed of signal evaluations and any safety- and efficacy-related procedures (referrals) of the EMA, FDA and MHRA. Signals from other authorities do not have to be reported. The following general principle applies: marketing authorisation holders are responsible for the safety of their medicinal products. They are obliged to update the medicinal product information – continuously and without being prompted – in line with the latest scientific and technical findings, new incidents and evaluations.
Swissmedic must be notified within 90 days of risk-minimisation measures decided as part of a PSUR/PSUSA procedure by the EMA.
Signals can be reported to Swissmedic by post (CD by post) or via the Portal.
For submissions via the Portal, the signal documentation together with the "Signal Notification Form" should be submitted as a "Safety Communication" via the eGov Portal (see Guidance document "Drug Safety Signals HMP"). Information on Portal registration can be found on the Swissmedic website via Services & lists à eGov services à eGov Portal à Registration eGov Portal.
The procedure for a company signal from a manufacturing partner in another country relating to a medicinal product authorised in Switzerland is the same as that for a regular company signal (according to the Guidance document "Drug Safety Signals HMP").
Yes, marketing authorisation holders of medicinal products with new active substances (NAS) and known active substances (KAS) with innovation must report signals from authorities.
Only marketing authorisation holders of KAS without innovation, biosimilars and co-marketing medicinal products who adapt their medicinal product information by conformation are not subject to the reporting obligation (for details see Guidance document "Drug Safety Signals HMP").
(Company signals must be reported regardless of the authorisation category of the medicinal product.)
Marketing authorisation holders are obliged to report signals relating to their authorised medicinal products or active substances. If a PRAC publication refers to a signal relating to an active substance that is not authorised in Switzerland, this does not need to be reported. If there is any doubt in individual cases, forwarding the signal to Swissmedic as a precautionary measure is recommended.
Yes, any measures decided as part of signal evaluation procedures must be implemented by marketing authorisation holders of known active substances with innovation as part of the signal evaluation procedure, even if other adaptations are made by conformation.
The obligation to submit reports begins on the day of authorisation and usually lasts for four years (for details see Guidance document "Information on PSUR PBRER submission HMP"). The reporting periods must follow on seamlessly from one another so that complete, uninterrupted coverage is guaranteed from the day of authorisation to the end of the required observation period. Furthermore, the observation periods for the submitted PSURs/PBRERs should not overlap.
Yes, the full legally stipulated period of 4 years from the date of authorisation must be covered without any gaps.
The reports should generally be submitted once a year and cover a 12-month period. The submission cycle can be modified (e.g. to harmonise it with the EU submission cycle) on request.
Submissions for PSUR/PBRER applications may be made in the formats eCTD (delivery type “variation/new application”) or eDOK (delivery type “communication”) via the Swissmedic eGov Portal or by post (CD by post) to Swissmedic.
PSURs do not usually need to be submitted for KAS (with or without innovation). However, a PSUR obligation can be imposed in individual cases, in which case the applicant/marketing authorisation holder will be notified in an official decision.
The EURD list contains all active substances and combinations of active substances and their EU reference dates, submission frequencies and data lock points for PSUR obligations in the EU, whereas the PSUR obligation in Switzerland is based on the authorisation date and status in Switzerland. Harmonisation of the submission frequency with the EU periodicity based on the EURD list is possible on request.
Knowledge of the exposure in Switzerland is essential to enable the potential risks to be evaluated and produce a risk-adjusted evaluation that reflects the realities of prescribing and use in Switzerland.
The stated number of patients refers to all patients who accessed the medicinal product after market launch – both via commercial and non-commercial supply channels (e.g. compassionate use programmes, named patient supply, sample dispensed by the marketing authorisation holder). Data from clinical trials are not taken into account.
Yes, the PSUR obligation restarts and applies for a period of 4 years from the date of conversion to an authorisation without special conditions ("non-limited authorisation").
RMP Updates associated with an application must be submitted together with the corresponding application.
The following applies to the submission of standalone RMP Updates:
Standalone RMP Updates should be submitted in the formats eCTD (delivery type "variation/new application") or eDOK (delivery type "communication") via the Swissmedic eGov Portal or by post (CD by post).
An EU RMP is usually submitted to Swissmedic. If there are major deviations from the submitted RMP that apply to Switzerland, an SSA should be prepared.
Such deviations include in particular:
There is no specified form for the SSA. However, the structure should, where possible, accord with Guideline E2E of the ICH and GVP Module V. The deviations described in the SSA should be listed as well as described and substantiated. An approved SSA is considered to be an integral part of the underlying RMP; the activities for the Pharmacovigilance Plan and risk minimisation measures listed therein must be implemented in full.
RMP Summaries are intended for healthcare professionals and third parties seeking information and are a supplement to the publicly available medicinal product information. They are published in English on the Swissmedic website.
The RMP Summary should be submitted within 60 calendar days after approval of the application for authorisation or the RMP Update as a separate document with a cover letter (not as a separate application). As a rule, the application will be published on the website within 30 days of submission.
For certain medicinal products, information material (also known as educational material) in addition to the information for healthcare professionals and patient information is required to inform healthcare professionals and patients on the safe use of the medicinal product (e.g. checklists, guidelines). Officially ordered information materials are considered by Swissmedic to refer to any information materials that are either listed in an RMP or SSA approved by Swissmedic, or that are ordered as a condition (e.g. for medicinal products that do not require an RMP).
Marketing authorisation holders must ensure that healthcare professionals, patients and carers have access to the materials and are able to order them physically at any time. If the distribution is not specified when the RMP is authorised or the information material is imposed as a condition, the current practice is for initial distribution by post (specimen copies, documentation of distribution). In the subsequent lifecycle, the provision of electronic forms is also possible in principle, provided the material can also be physically reordered at any time. Officially ordered information material that must be signed (e.g. risk information forms) and officially ordered information material for patients (e.g. patient cards) are not provided in electronic forms.
The provision of information material to patients by the treating healthcare professional is essential to ensure the safe use of the medicinal product. However, the Therapeutic Products Act does not include a specific legal obligation to provide these materials.
Nevertheless, there is an obligation implicit in professional and liability legislation, as part of the general duty of care for healthcare professionals, to implement officially ordered safety measures. In individual cases, it may therefore be relevant from the standpoint of liability law whether, and if so how, patients were informed about the content of the information material.
Stating references in the officially ordered information material is not mandatory, but the applicable regulations must be observed. The provisions of GVP Modules V, XVI and XVI Addendum must be applied as appropriate when producing officially ordered information material. For instance, these must not contain any promotional content or inconsistencies with the medicinal product information, i.e. the material must be adapted continuously to the approved medicinal product information.
Explicit approval of officially ordered information material does not usually occur. The provisions of GVP Modules V, XVI and XVI Addendum should be applied as appropriate when producing the information material. For instance, it cannot contain any advertising; the documents submitted must not contradict the medicinal product information and must be adapted continuously to this information. The legal responsibility for the content of the material rests with the marketing authorisation holder. The materials must be provided to Swissmedic on request.
All information material must be made available in the official Swiss languages (German, French, Italian). If, in exceptional cases, the information material is to be distributed exclusively in English, explicit approval by Swissmedic is required, but such approval is not required if the information material is provided in English in addition to the official Swiss languages.
No. All information material must be provided in the official Swiss languages. In justified exceptional cases, the exclusive use of English documents can be requested and requires the approval of Swissmedic.
Swissmedic requires that risk‑minimising information materials be provided which match those of the reference product in both content and purpose.
The official decision specifies the risks that must be covered and the materials to be implemented. The aim is to ensure that users have access to the same safety-related information that is available for the reference product.
The decisive factor is whether this RMP (incl. information material) was approved by Swissmedic or whether, for example, information material was ordered in connection with a signal. If so, it is considered to be "officially ordered information material".
The Guidance document "RMP ICH E2E Information submission HMP" does not explicitly require the redistribution of existing ordered information materials when the new "Blue safety information" is added.
The Guidance document "RMP ICH E2E Information submission HMP" requires officially ordered information materials to be identified in order to rule out any risk of confusion with promotional materials. This is mandatory as of 1 July 2026. As a rule, all materials, including those in the medicinal product packaging, must be identified.
An exemption applies to materials in credit card format. In this case, identification is not mandatory (see Guidance document "RMP ICH E2E Information submission HMP"). Deviations in order to take account of specific circumstances can be requested.
The RMP summaries published on the Swissmedic website contain information on the type and content (addressed risks) of the necessary information material. In-house monitoring by companies should be able to identify updates to the RMP Summary for the reference product / reference preparation.
If a marketing authorisation holder of a medicinal product with a known active substance / biosimilar believes that the information material needs to be adapted (e.g. cancellation of patient card, inclusion of an additional risk), a request for adaptation of the information material should be submitted to Swissmedic (application type: "Removal of a condition relating to drug safety"). The request for a "Removal of a condition relating to drug safety" should be submitted in the form of a cover letter describing what condition should be cancelled. The request is submitted in the formats eCTD (delivery type "variation/new application") or eDOK (delivery type "communication") via the Swissmedic eGov Portal or by post (CD by post).
No, a DHPC must always be sent by post.
DHPCs are produced separately in each of the three Swiss languages (German, French Italian). The "Red safety information" symbol in the Swiss language specific to the target readership should be placed right-aligned on the first page of the DHPC. On the envelopes, the "Red safety information" symbol can be used in the Swiss language specific to the target readership or, alternatively, in its multilingual form.
