Guidance document RMP / ICH E2

1 Abbreviations

aRMM Additional risk minimisation measure Art. Article eCTD Electronic Common Technical Document (ICH) EMA European Medicines Agency EU European Union GVP Guideline on good pharmacovigilance practices ICH International Conference of Harmonisation ICH E2E ICH Harmonised Tripartite Guideline on Pharmacovigilance Planning E2E KAS Known active substance Let. Letter NAS New Active Substance No. Number Para. Paragraph PASS Post-Authorisation Safety Study / Studies PSUR/PBRER Periodic Safety Update Report/Periodic Benefit Risk Evaluation Report PVP Pharmacovigilance Plan Rev. Revision RMM Risk minimisation measures RMP Risk Management Plan rRMM Routine risk minimisation measure SSA Switzerland-specific annex TPA Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA; SR 812.21) TPO Ordinance on Therapeutic Products (Therapeutic Products Ordinance – TPO, SR 812.212.21) TPLO Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (SR 812.212.23) TPLRO Ordinance of the Swiss Agency for Therapeutic Products on the Licensing Requirements for Therapeutic Products (Therapeutic Products Licensing Requirements Ordinance, TPLRO; SR 812.212.22)

2 Objective

This Guidance document describes the requirements for submitting Risk Management Plans (RMPs), RMP Updates, and RMP Summaries. It instructs marketing authorisation holders on the formal and regulatory aspects that apply in this regard.

3 Introduction

The RMP for a therapeutic product describes the primary risks (“safety concerns”) derived from the safety profile (“safety specifications”) of this therapeutic product, the pharmacovigilance activities that are required for further characterisation of the safety concerns (“pharmacovigilance plan”), and the

risk minimisation measures for reducing the probability that the risks will come into effect. The RMP is part of the authorisation dossier.

4 Risk Management Plan (RMP)

4.1 Legal basis

Art. 11 para. 2 let. a no. 5 of the Therapeutic Products Act (TPA) states that applications for authorisation of a therapeutic product with indication must include an assessment of the risks and, if applicable, a plan for their systematic recording, investigation and prevention (pharmacovigilance plan). This mandatory submission is described in more detail in Art. 4 TPO.

4.2 RMP mandatory submission

Applications for authorisation of human medicinal products containing at least one new active substance (NAS) (including orphan drug NAS) must always include a Risk Management Plan. Applications for authorisation of a medicinal product that does not qualify for the simplified authorisation procedure under Art. 12 para. 5 let. a-e TPLO must also be accompanied by an RMP. Biosimilars do not require an RMP. The obligation to submit RMP Updates is described in section “RMP Updates”. Swissmedic will not review, and therefore not approve, any RMPs that are presented in the absence of a submission requirement.

4.3 Content and format of an RMP

The structure of the RMP must follow Guideline E2E of the ICH (“pharmacovigilance planning”) or GVP Module V Rev. 2 (risk management systems) from the EMA (Art. 11 para. 4 TPA in conjunction with Art. 5a para. 1 TPLRO in conjunction with Annex 3 para. 1 let. a. TPO). Any RMP that complies with the aforementioned legal requirements can be submitted. Submission of an EU RMP is preferable. The EMA’s "Guidance on the format of the risk management plan (RMP) in the EU – in integrated format" provides additional details on the content and format of the EU RMP. In addition to this, a Switzerland-specific annex (SSA) can be submitted to describe deviations from the submitted RMP that apply exclusively to Switzerland (see section “Switzerland-specific annex to the RMP”).

5 RMP submission in a first-time authorisation procedure

5.1 Ordinary procedure according to Art. 11 TPA

An RMP must be submitted in accordance with the remarks in section "RMP mandatory submission". As a rule, under Art. 11 para. 1 TPA all information and documents that are relevant for the decision must be submitted; this particularly includes the submission of RMP-related assessment reports from other agencies.

5.2 Simplified procedure according to Art. 14 TPA

Pursuant to Art. 4 para. 1 TPO, submission of an RMP is required for the authorisation process only in the case of those applications listed in this provision (let. a to c). No RMP is needed when applying for authorisation of medicinal products that qualify for the simplified procedure under Art. 14 TPA.

5.3 Authorisation under Art. 13 TPA

If an authorisation application is submitted under Art. 13 TPA, the requirements of Art. 16 et seq. TPO also apply; accordingly, the documentation filed with Swissmedic must correspond to the documentation that was submitted to the reference authority. This means that the documentation submitted would also have to include any RMP filed with the reference authority. For authorisation applications in accordance with Art. 13 TPA that pertain to medicinal products under

Art. 4 TPO (human medicinal products that contain at least one new active substance [NAS] or a new

indication for this medicinal product), under Swiss Module 1.8.2 an RMP to be approved by Swissmedic must also be submitted. The latest RMP approved by the reference authority, including the assessment report, must be submitted; if there is no newer version of the RMP contained in the reference dossier, then the RMP in Swiss Module 1.8.2. will be identical to this. If the reference authority is the FDA, an RMP and, if available, the associated assessment report, should also be submitted in Swiss Module 1.8.2. Preferably, the approved EU RMP should be submitted whenever possible.

5.4 Summary of mandatory RMP for first-time applications for authorisation

Figure 1: Medicinal products requiring an RMP (authorisation under Art. 11 and active substances that do not qualify for simplified authorisation under Art. 12 para. 5 let. a-e TPLO)

Figure 2: Medicinal products requiring an RMP under Art. 13 TPA

Figure 3: Medicinal products not requiring an RMP

6 RMP Updates

6.1 Preconditions for submission

An RMP Update under this guidance document refers to any RMP that is submitted in order to replace a previously approved RMP. RMP Updates are to be submitted only if the first submitted RMP was approved by Swissmedic. (Exception: Applications for indication extensions for an NAS and for active substances that did not qualify for simplified authorisation under Art. 12 para. 5 let. a-e TPLO [see section “Applications for indication extensions”]). RMP Updates do not need to be submitted for KAS and biosimilars for which an RMP has been approved by Swissmedic in the past. The obligation to implement additional risk minimisation measures (aRMMs, definition see section “Definition of aRMMs and officially mandated information materials”) and specific conditions relating to the RMP still applies. If adaptations need to be made to

the aRMMs as a result of a changed risk assessment (e.g. inclusion of additional risks on the patient card) or if the aRMMs are no longer considered necessary, the authorisation holder of the KAS/biosimilar can submit these adaptations with a request “Removal of a condition relating to drug safety”.

6.2 Specific procedures

6.2.1 Applications for indication extensions

Under Art. 4 para. 1 let. c TPO, applications for indication extensions for an NAS (including orphan drug NAS) must always include an RMP Update. This also applies to indication extensions for active substances that did not qualify for simplified authorisation under Art. 12 para. 5 let. a-e TPLO. The cover letter must indicate the most recent version of the RMP that was approved by Swissmedic and, if applicable, the SSA (see section “Switzerland-specific annex to the RMP”).

6.2.2 RMP Updates in the context of other applications

RMP Updates should be submitted in the context of other applications if at least one of the following aspects of the RMP content is affected by the update:

Summary of safety concerns: addition, modification or deletion of risks
Additional pharmacovigilance activities: addition, modification (e.g. of milestones or design of PASS) or deletion of additional PV measures and/or
Additional risk minimisation measures: introduction, modification or deletion of aRMMs. If there is a need for an RMP Update due to other applications, such as applications for modifications to medicinal product information, applications to remove requirements or the submission of PSUR/PBRER, this update must be included with the relevant application. The RMP will be evaluated and approved as part of this application. An EU RMP version can be submitted even if not yet approved. The cover letter must indicate the most recent version of the RMP that was approved by Swissmedic.

6.2.3 RMP Updates as a standalone application

RMP Updates that are not directly associated with an application must be submitted as a standalone "AMS RMP Update" application with a cover letter. If an EU RMP is involved, this should be submitted to Swissmedic as part of a standalone RMP Update only after it has been approved by the EMA (for time limits see section “Time limits and fees”). Submissions must be made via the Swissmedic Portal with the delivery type "communication", if eCTD delivery type "variation/new application" or CD by post. The cover letter must indicate the most recent version of the RMP that was approved by Swissmedic and, if applicable, the Switzerland-specific annex (see section “Switzerland-specific annex to the RMP”).

6.2.4 Summary of the RMP Update requirement

Figure 4: Applications for indication extensions

Figure 5: RMP Updates during the life cycle of a medicinal product

6.3 Time limits and fees

RMP Updates relating to an application must be presented at the same time as the application; the time limits for the respective application apply in addition thereto. The time limits for submitting standalone RMP Updates are as follows:

EU RMP: within 3 months after approval of the RMP Update by the EMA ("CHMP opinion date").
If an EU RMP is not involved: within 3 months after the "final sign off" of the RMP Update.

The fee for reviewing standalone RMP Updates is charged according to the actual time spent pursuant to Art. 1 in conjunction with Art. 4 of the Ordinance on the fees charged by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic; SR 812.214.5) dated 14 September 2018.

7 Switzerland-specific annex to the RMP

7.1 Legal basis

Pursuant to Art. 11 para. 2 let. a no. 5 TPA, as a rule an RMP must be submitted with an application for authorisation; if adaptations must be made to the submitted RMP to account for the situation in Switzerland, a Switzerland-specific annex (SSA) to the RMP must also be filed. The option to submit country-specific annexes is an efficient means of accounting for national situations and corresponds to international practice.

7.2 Procedure

There is no specific procedure for submitting an SSA. The SSA can be submitted along with an RMP for an authorisation application or with an RMP Update. If a Switzerland-specific annex to the RMP has been approved, it must always be submitted together with the RMP Update.

7.3 Content and format of an SSA

In the event of significant deviations from the submitted RMP that apply exclusively to Switzerland, an SSA with details of the deviations must be filed. Such deviations include in particular:

Summary of safety concerns,
Additional pharmacovigilance activities and/or
Additional risk minimisation measures1. The deviations should be listed as well as described and/or substantiated. While there is no legally required form of the SSA, the structure should – where possible and reasonable – be aligned to Guideline E2E of the ICH (pharmacovigilance planning) and GVP Module V. An approved SSA shall be considered an integral part of the underlying RMP; the activities for the pharmacovigilance plan and risk minimisation measures listed therein must be implemented in full. If an SSA is approved, this should always be submitted together with any RMP Update.

8 RMP Summary

8.1 Legal basis

Submission of an RMP Summary is mandatory under Art. 5a para. 2 TPLRO. On the basis of Art. 68 para. 1 let. e. no. 2 TPO, Swissmedic publishes RMP Summaries for authorised medicinal products on its website. RMP summaries are intended for healthcare professionals and third parties seeking

1The method of distribution of information material may differ from the details in the RMP; these deviations do

not have to be described in the SSA (see section “Provision and distribution of officially mandated information material”).

information, and are a supplement to the publicly available medicinal product information. Approval of an application that includes an RMP is subject to submission of an RMP Summary.

8.2 Submission

The RMP Summary must be submitted to Swissmedic as a standalone document with cover letter (not as a separate application) (submission via Swissmedic Portal delivery type "communication", if submitted via eCTD delivery type "variation/new application" or CD by post). The RMP Summary should be submitted in English; publication will also be in English in accordance with Art. 68 para. 3 sentence 2 TPO. A translation into the Swiss national languages is not envisaged. Following a formal review of the RMP Summary submitted, it will be published as described above. No separate correspondence is conducted with the marketing authorisation holder. In the event of a complaint, the marketing authorisation holder will be contacted.

8.3 Content and format of an RMP Summary

The form of the RMP Summary should correspond to the EMA’s "Guidance on format of the risk management plan in the European Union" (Part VI)". When drafting the summary, ensure that it is complete (in particular, all risk aspects ("summary of safety concerns"), additional pharmacovigilance activities and additional risk minimisation measures specified in the RMP and any existing SSA should be taken into account) and easily comprehensible. The following should be added to the document intended for publication: ▪ Title page – stating the name of the medicinal product, active substance, version number of the underlying RMP and version number of any SSA, name of the marketing authorisation holder, date, and the following disclaimer word for word: The Risk Management Plan (RMP) is a comprehensive document submitted as part of the application dossier for market approval of a medicine. The RMP Summary contains information on the medicine's safety profile and explains the measures that are taken in order to further investigate and follow the risks as well as to prevent or minimise them. The RMP summary of "Medicinal product name" is a concise document and does not claim to be exhaustive. As the RMP is an international document, the summary might differ from the "Medicinal product information / Arzneimittelinformation / Information sur le médicament" approved and published in Switzerland, e.g. by mentioning risks occurring in populations or indications not included in the Swiss authorisation. Please note that the reference document which is valid and relevant for the effective and safe use of "Medicinal product name" in Switzerland is the "Medicinal product information / Arzneimittelinformation/ Information sur le médicament" (see www.swissmedic.ch) approved and authorised by Swissmedic. "Name of the marketing authorisation holder" is fully responsible for the accuracy and correctness of the content of the published RMP summary of "Medicinal product name".

8.4 Time limits

The RMP Summary must be sent to Swissmedic within 60 calendar days (CD) after approval of the application for authorisation or the RMP Update. As a rule, the application will be published on the Swissmedic website within 30 days of submission.

9 Implementation of the RMP

As a rule, approval of the RMP requires the marketing authorisation holder to implement the RMP upon introduction of the medicinal product in Switzerland. This applies in particular to:

The pharmacovigilance plan with the activities described therein (e.g. specific / targeted follow-up questionnaires), post-authorisation safety studies [PASS], etc.),
Risk-minimisation measures (appropriate warnings in the information for healthcare professionals and patients, design of the packaging material, aRMMs such as patient cards, checklists, etc.) Any intended deviations must be described and substantiated in an SSA (see section “Switzerlandspecific annex to the RMP”) (this does not apply to differences between the product information details given in the RMP compared to the text of the Swiss medicinal product information; this will be reviewed independently of the RMP). If a Swissmedic-approved RMP covers different pharmaceutical forms, implementation of the RMP is mandatory for all pharmaceutical forms authorised in Switzerland. This also applies to subsequent authorisation extensions. Medicinal products may only be placed on the market with implementation of the pharmacovigilance plan and risk minimisation measures. All aRMMs, including officially mandated information material, must always be implemented or available from the time of market launch of a medicinal product. Swissmedic will review the full implementation of the RMP by way of pharmacovigilance inspections, among other things.

9.1 Implementation of the pharmacovigilance plan (PVP)

As a rule, the complete pharmacovigilance plan must be adopted in a manner suitable for Switzerland. This means, for example, that risk-related questionnaires (targeted questionnaires and follow-up questionnaires) must be provided in all of the official languages. A routine submission of study reports is not envisaged. Study reports on studies mentioned in the PVP must be submitted only if submission of these study reports was expressly stipulated as a condition. However, if the results of studies mentioned in the PVP lead to changes in the product information or other risk minimisation measures, the study reports should be submitted in the context of the corresponding variation application. On the basis of Art. 28 TPO, marketing authorisation holders are obliged to update their product information in line with the latest scientific and technical findings, new incidents and evaluations.

9.2 Implementation of additional risk minimisation measures (aRMMs)

This section applies to both medicinal products that require and do not require an RMP (for medicinal products that do not require an RMP, see also section “Additional clarifications on medicinal products that do not require an RMP”). Additional risk minimisation measures (aRMMs), including officially mandated information material, must be implemented in Switzerland as described in the RMP and, if applicable, the SSA. In particular, this concerns the type of aRMM and the risks addressed. The method of distribution of officially mandated information material may differ from the details in the RMP. These deviations do not have to be described in an SSA (regarding distribution, see section “Provision and distribution of officially mandated information material”).

9.2.1 Definition of aRMMs and officially mandated information materials

Risk minimisation measures (RMMs) are subdivided into routine (rRMMs) and additional RMMs (aRMMs). aRMMs can be further subdivided into information materials (also known as “educational materials” according to GVP) and control instruments for risk minimisation. Information materials are aimed at patients or healthcare professionals and are designed to support compliance with the planned risk minimisation measures. Examples of information materials include guides for patients and healthcare professionals, checklists for healthcare professionals, patient cards and patient diaries. Officially mandated information materials are considered by Swissmedic to refer to any information materials that are either listed as aRMMs in an RMP approved by Swissmedic or in the SSA, or that are mandated as a condition (e.g. for medicinal products that do not require an RMP, see section “Additional clarifications on medicinal products that do not require an RMP”). Control instruments for risk minimisation are designed to ensure that patients are given the necessary support in the safe use of the medicinal product, prevent misuse of the product and/or ensure traceability of the medicinal product (e.g. "Controlled access programme"). All aRMMs that are listed in an RMP approved by Swissmedic or, if applicable, in the SSA, must be implemented in Switzerland.

9.2.2 Content and format of officially mandated information material

The provisions of GVP Module V, XVI and XVI Addendum must be applied as appropriate when creating officially mandated information materials such as patient cards, checklists, educational videos, etc. For instance, these cannot contain any promotional content; the documents submitted cannot be inconsistent with the product information and must be adapted continuously to the approved product information. RMMs must be implemented in accordance with the Switzerland-specific rules, which means that alongside the product information (rRMMs) aRMMs such as patient cards, checklists, educational videos, etc. must be provided in all official Swiss languages. In individual cases, and subject to the explicit approval of Swissmedic, officially mandated information material can be made available in English rather than in the official Swiss languages. The legal responsibility for the content of the material remains with the marketing authorisation holder. The officially mandated information materials must be submitted to Swissmedic on request.

9.2.3 Identification of officially mandated information materials

In order to make a clear distinction for the target readership of officially mandated information materials between advertising materials and officially mandated information materials, officially mandated information materials approved by Swissmedic must be identified by the "Blue safety information" symbol. Only aRMMs in accordance with the RMP approved by Swissmedic or with a condition are considered to be officially mandated information materials. Information materials that are not officially mandated may not show this symbol. This identification should ensure that the target readership is reached more reliably, thereby further improving drug safety.

Figure 6: "Blue safety information" symbol (English)

Figure 7: "Blue safety information" symbol (multilingual)

The symbol must be displayed both on the officially mandated information materials and the envelope used to send the enclosed materials, see also section “Exemptions”. The "Blue safety information" symbol is available in the official Swiss languages and in English and should be used in accordance with the language of the officially mandated material. The symbols can be downloaded from the Swissmedic website. The following sections refer exclusively to officially mandated information materials.

9.2.3.1 Placing and size of the symbol

On officially mandated information materials, the "Blue safety information" symbol should be clearly visible and appear once on the first page/cover page or at the start of a training/educational video/presentation. The size of the "Blue safety information" symbol can be adapted to the officially mandated information material. The symbol should be large enough to be clearly legible. When the officially mandated information materials are initially sent by post, the “Blue safety information” symbol must be clearly visible on the cover letter for healthcare professionals (first page, header) and the envelope (front). The “Blue safety information” symbol should also be used in the cover letter for officially mandated information materials that are initially sent electronically.

On the envelope and cover letter, the symbol should be used in the Swiss language specific to the target readership or, alternatively, in its multilingual form. When the materials are sent by post, the minimum sizes of the "Blue safety information" symbol for the envelope and the cover letter as shown in Figures 8 and 9 should be observed. For materials that are sent electronically, the symbol must be clearly legible in the cover letter with standard settings. When officially mandated information materials are reordered, the symbol is not mandatory on the envelopes or the cover letter.

Figure 8: Minimum size of the "Blue safety information" symbol (monolingual)

Figure 9: Minimum size of the "Blue safety information" symbol (multilingual) If the officially mandated information materials and/or the envelope are also provided with the company logo, the size of the company logo must not exceed 2/3 of the "Blue safety information" symbol.

9.2.3.2 Disclaimer

In addition to the "Blue safety information" symbol, the following disclaimer should appear on the first “Exemptions”).

9.2.3.3 Disclaimer in German

Intended for healthcare professional: Dieses Informationsmaterial wurde als risikominimierende Massnahme durch Swissmedic angeordnet. Es soll sicherstellen, dass Angehörige der Heilberufe die besonderen Sicherheitsanforderungen von [name of the medicinal product, any necessary additions] kennen und berücksichtigen. Die rechtliche Verantwortung für das Informationsmaterial liegt bei [name of the marketing authorisation holder].

Intended for patient: Dieses Informationsmaterial wurde als risikominimierende Massnahme durch Swissmedic angeordnet. Es soll sicherstellen, dass Patientinnen und Patienten und/oder Angehörige und/oder Betreuungspersonen (select as appropriate or add if required) die besonderen Sicherheitsanforderungen von [name of the medicinal product, any necessary additions] kennen und berücksichtigen. Die rechtliche Verantwortung für das Informationsmaterial liegt bei [name of the marketing authorisation holder].

9.2.3.4 Disclaimer in French

Intended for healthcare professional: Ce matériel d’information a été exigé par Swissmedic au titre de mesure de réduction des risques. Il vise à garantir que le personnel de santé connaît et prend en compte les exigences particulières en matière de sécurité relatives à [name of the medicinal product, any necessary additions]. La responsabilité juridique du matériel d’information incombe à [name of the marketing authorisation holder]. Intended for patient: Ce matériel d’information a été exigé par Swissmedic au titre de mesure de réduction des risques. Il doit garantir que les patientes et patients et/ou les proches et/ou le personnel soignant (select as appropriate or add if required) connaissent et prennent en compte les exigences particulières en matière de sécurité relatives à [name of the medicinal product, any necessary additions]. La responsabilité juridique du matériel d’information incombe à [name of the marketing authorisation holder].

9.2.3.5 Disclaimer in Italian

Intended for healthcare professional: Il presente materiale informativo è stato richiesto da Swissmedic come misura di riduzione dei rischi, con l’obiettivo di consentire agli operatori sanitari di conoscere e tenere in considerazione gli specifici requisiti di sicurezza relativi a [name of the medicinal product, any necessary additions]. La responsabilità legale del materiale informativo è in capo a [name of the marketing authorisation holder]. Intended for patient: Il presente materiale informativo è stato richiesto da Swissmedic come misura di riduzione dei rischi, con l’obiettivo di consentire alle e ai pazienti e/o alle relative parenti e ai relativi parenti e/o al personale di assistenza (select as appropriate or add if required) di conoscere e tenere in considerazione gli specifici requisiti di sicurezza relativi a [name of the medicinal product, any necessary additions]. La responsabilità legale del materiale informativo è in capo a [name of the marketing authorisation holder].

9.2.3.6 Disclaimer in English

Intended for healthcare professional:

This information material has been mandated by Swissmedic as a risk minimisation measure. It is intended to ensure that healthcare professionals know and take into account the specific safety requirements of [name of the medicinal product, any necessary additions]. Legal responsibility for the information material lies with [name of the marketing authorisation holder]. Intended for patient: This information material has been mandated by Swissmedic as a risk minimisation measure. It is intended to ensure that patients and/or relatives and/or carers (select as appropriate or add if required) know and take into account the specific safety requirements of [name of the medicinal product, any necessary additions]. Legal responsibility for the information material lies with [name of the marketing authorisation holder].

9.2.3.7 Exemption

The inclusion of the symbol and disclaimer is not mandatory on officially mandated information materials in credit card format. If the disclaimer is not included, the disclaimer, together with the "Blue safety information" symbol must be shown on the cover letter (sent initially). For all other formats, the symbol and disclaimer must be included and be clearly legible. However, if an exemption should prove to be necessary in individual cases, the circumstances should be presented to Swissmedic for review as part of the corresponding ongoing application, or in connection with officially mandated information materials that already exist, in an e-mail to riskmanagement@swissmedic.ch (stating the most recently approved RMP version and, if applicable, the SSA Version and the corresponding application ID). If a new version of the same officially mandated information material is issued, a further request to omit the symbol and/or the disclaimer is not necessary if the space available remains unchanged. In individual cases, and subject to the explicit approval of Swissmedic, officially mandated information material can be made available in English rather than in the official Swiss languages. In this case, the "Blue safety information" symbol and the disclaimer should be used in English.

9.2.4 Provision and distribution of officially mandated information material

Marketing authorisation holders are responsible for providing and distributing officially mandated information material. To maintain medicinal product safety, marketing authorisation holders must ensure that healthcare professionals, patients and carers have access to the full, up-to-date officially mandated information materials at all times. This includes both permanent electronic availability (see section “Publication of officially mandated information materials”) as well as being able to order all officially mandated information materials physically at any time (exception: officially mandated information materials that are not physically available, such as videos). Initial distribution must be in an appropriate format (e.g. sending specimen copies) in order to guarantee initial implementation. Marketing authorisation holders must ensure that healthcare professionals are informed of available officially mandated information material and are informed in a timely manner of updates to content.

Distribution (initial and updates) must be documented clearly.

9.2.5 Publication of officially mandated information material

To ensure healthcare professionals and patients have access to officially mandated information material at all times, this must be published on the electronic publication platform in all three official Swiss languages2. If parts of the aRMM cannot be published on the electronic publication platform (e.g. elements of a “controlled access programme”), Swissmedic must be informed in the course of the RMP evaluation. In the absence of specific notification, Swissmedic will assume that all aRMMs will be published on the electronic publication platform.

9.2.6 Time limits for implementing officially mandated information material for new

authorisations

All aRMMs, including officially mandated information material, must always be implemented or available from the time of market launch of a medicinal product. In the case of new authorisations, officially mandated information material must be published on the electronic publication platform by the time of market launch at the latest.

9.2.7 Time limits for implementing changes to officially mandated information material

9.2.7.1 Medicinal products that require an RMP

If content-relevant changes to the officially mandated information material are necessary or new officially mandated information material is introduced during the lifecycle of a medicinal product, this must be implemented at the next reprint but at the latest 12 months after the official decision on the RMP or the relevant application. A time limit of three months applies for electronic publication. Riskbased shorter time limits may be mandated in individual cases.

9.2.7.2 Medicinal products that do not require an RMP

The requirements in this section apply with effect from 1 November 2026. If officially mandated information material is introduced or the existing material is updated for the reference medicinal product/reference product/basic product after authorisation of the KAS/biosimilar/co-marketing medicinal product, this must be applied by conformation for the relevant KAS/biosimilar/co-marketing medicinal product within four months after publication on the electronic publication platform (publication date of the electronic version) or with the next reprint, but within 12 months at the latest (provision of the printed version) without being requested by Swissmedic. Relevant changes to content of the officially mandated information material that must be applied by conformation include:

• inclusion of additional risks

In individual cases, and subject to the explicit approval of Swissmedic, officially mandated information material can be made available in English rather than in the official Swiss languages (see section “Content and format of officially mandated information material”).

deletion of risks
introduction of new materials/elimination of materials In general, it is also required for conformation that the details in the officially mandated information material correspond to those in the medicinal product information (e.g. with regard to authorised indications, authorised pharmaceutical forms, etc.).

9.2.8 Transitional period for publication of existing officially mandated information

materials

For medicinal products that have existing officially mandated information materials when this guidance document comes into force, these must be made available to the electronic publication platform for publication by 1 November 2026 at the latest.

10 Additional clarifications on medicinal products that do not require

an RMP

The requirements in this section apply with effect from 1 November 2026. In general, aRMMs are related to the active substance and apply analogously to both the reference medicinal product/reference product/basic product and the KAS/biosimilar/co-marketing medicinal product.

10.1 Officially mandated information material published on the electronic

publication platform

10.1.1 Medicinal products authorised before 1 November 2026

For medicinal products that do not require an RMP and for which aRMMs, analogous to those of the reference medicinal product/reference product/basic product, were mandated in the past by specific condition (i.e. specifying the type of information material and the risks addressed), the condition continues to apply unchanged. The same applies for obligations from an RMP approved by Swissmedic in the past. If the reference medicinal product/reference product/basic product has been authorised, the officially mandated information material published on the electronic publication platform and the RMP summary published on the Swissmedic website for the relevant reference medicinal product/reference product/basic product form the basis (reference) for any changes to the officially mandated information material. If the officially mandated information material needs to be adapted to the reference medicinal product/reference product/basic product (e.g. cancellation of patient card, inclusion of an additional risk), an application for the relevant change to the officially mandated information material must be submitted to Swissmedic (application type: “Removal of a condition relating to drug safety”). On completion of the application, the standard condition of conformation of the information material to the reference medicinal product/reference product/basic product is imposed. Future changes can be made without notifying Swissmedic.

If the reference medicinal product/reference product is no longer authorised or the authorisation has been converted to an export licence, the marketing authorisation holder is independently responsible for the officially mandated information material, as in the case of the content of the medicinal product information. Any changes required (deletion/introduction of material, change to the risks addressed) must be submitted to Swissmedic for review in this case (via application “Removal of a condition relating to drug safety”).

10.1.2 Medicinal products authorised after 1 November 2026 with an authorised reference

medicinal product/reference product at the time of authorisation and co-marketing medicinal products

All KAS and biosimilars authorised after 1 November 2026 with a reference medicinal product/reference product at the time of authorisation are required under a standard condition to conform to any officially mandated information material. This also applies to co-marketing medicinal products authorised after 1 November 2026. This standard condition is always mandated, irrespective of whether the reference medicinal product/reference product/basic product has officially mandated information material at that time or not. The officially mandated information material published on the electronic publication platform and the details of the RMP summary published on the Swissmedic website for the reference medicinal product/reference product/basic product serve as a reference for the officially mandated information material and any later changes. Implementation and changes can be carried out without notifying Swissmedic. If in exceptional cases, aRMMs that differ from those for the reference medicinal product are advisable for a KAS with innovation, these must be communicated to Swissmedic with a justification as part of the application for authorisation (see form “New authorisation of human medicinal products”). In the event of cancellation of the authorisation of the reference medicinal product/reference product or conversion of the authorisation to an export licence, the obligation to implement the officially mandated information material for the relevant KAS/biosimilar remains unchanged. The marketing authorisation holder for the KAS/biosimilar is then, as in the case of the content of the medicinal product information, independently responsible for the officially mandated information material. Any changes required (deletion/introduction of material, change to the risks addressed) must be submitted to Swissmedic for review in this case (via application “Removal of a condition relating to drug safety”).

10.1.3 Medicinal product with authorisation after 1 November 2026 without reference

medicinal product/reference product at the time of authorisation

For medicinal products that do not require an RMP for which there is not an authorised reference medicinal product/reference product at the time of authorisation, applications must be submitted to Swissmedic for aRMMs necessary to ensure medicinal product safety, e.g. those approved or recommended by other authorities such as the EMA, FDA or MHRA (see form “New authorisation of medicinal products”). If the necessity of an aRMM is confirmed, implementation is mandated as a condition. If at a later date an aRMM is no longer considered necessary due to a change in risk assessment, the marketing authorisation holder can submit an application for “Removal of a condition relating to drug safety”.

Swissmedic can also impose aRMMs as a condition at any time to ensure medicinal product safety.

10.1.4 Documentation of conformation

Conformation of the officially mandated information material to the reference medicinal product/reference product/basic product must be clearly documented. In addition, a copy of the underlying version of the officially mandated information material for the reference medicinal product/reference product/basic product must be filed together with the documentation.

10.2 aRMMs not published on the electronic publication platform

aRMMs such as specification requirements of a “controlled access programme” are not published on the electronic publication platform. In this case, additional requirements in regard to the KAS/biosimilar/co-marketing medicinal product are defined by specific condition as part of the new authorisation application or a procedure.

11 Queries

Please submit queries in writing to riskmanagement@swissmedic.ch. We also welcome suggestions for improvement to this guidance document.

Change history Version Description sig

7.0 Section 7.3 “Content and format” has been renamed “Content and format of an SSA” and dst, the content has been revised: Deviations regarding risk aspects require an SSA where run, these relate to the “summary of safety concerns” (previously “safety concerns”); Fig. 5 has caw been adapted accordingly. Section 9 “Implementation of the RMP”: Clarification of the validity of the RMP for different pharmaceutical forms. Changes to the disclaimers (gender-compliant formulation in German and Italian disclaimers, “ordered” replaced by “mandated” in the English disclaimer). Section 9.2 “Implementation of additional risk minimisation measures (aRMMs)” has been restructured, some existing subsections have been moved and regrouped in terms of

Section 9.2.2 “Content and format” has been renamed “Content and format of officially mandated information material” and the content supplemented with a framework for provision of information material in English.
Section 9.2.3 “Implementation of aRMMs for medicinal products that do not require an RMP”: Information integrated into the new section 10.
Section 9.2.4.4 “Transitional period for the implementation of identification” has been deleted (no longer valid). New sections Section 9.2.4 “Provision and distribution of officially mandated information material”: Definition of requirements Section 9.2.5 “Publication of officially mandated information material”: Definition of requirements Section 9.2.6 “Time limits for implementing officially mandated information material for new authorisations”: Definition of requirements Section 9.2.7 “Time limits for implementing changes to officially mandated information material”: Definition of requirements Section 9.2.8 “Transitional period for publication of existing officially mandated information materials” Section 10 “Additional clarifications on medicinal products that do not require an RMP”: Definition of requirements

Editorial changes in various sections, “ordered” replaced by “mandated” in all occurrences of “officially ordered information material”.

6.0 Section 1: Updating of abbreviations dst

Section 4.3: "Content and format of an RMP" section was renamed and moved and applies to all RMP submissions (replaces specific information on RMP Updates) Section 5.3: In Swiss Module 1.8.2, the latest RMP approved by the reference authority should be submitted. Additional information: If the reference authority is the FDA, an RMP should also be submitted in Swiss Module 1.8.2. Section 5.4: Changes according to section 5.3 in Fig. 2, addition of biosimilars in Fig. 3 Section 6.1: Applications for indication extensions for NAS (and for active substances that do not qualify for simplified authorisation under Art. 12 para. 5 let. a-e TPLO) must always be accompanied by an RMP, even if no initially approved RMP is available Section 6.2.3: EU "standalone" RMP Updates may be submitted to Swissmedic only after they have been approved by the EMA. Section 9.2: Restructured, new subsection on the definition of aRMMs and officially ordered information materials (section 9.2.1) and new subsection on the identification of officially ordered information materials (section 9.2.4)

Other editorial changes and deletion of redundant content.

5.0 Section 4: Additional information on which applications or medicinal products are wue

subject to mandatory submission; details on specific authorisation procedures Section 5: Additional information on submission of an RMP Update; details on specific procedures Section 6: Additions to the Switzerland-specific annex Section 7: Comprehensive information on the RMP Summary Section 8: New section on implementation of the RMP Section 8.2.1: New section on implementation of additional risk minimisation measures for medicinal products that do not require an RMP

Additional, comprehensive edits in all sections

4.0 Section 6: Additional information on the RMP obligation in the context of dst

authorisation procedures Section 7: Additional information on the preconditions and the procedure for submitting RMP Updates New: Subsection 8.1: Switzerland-specific annex (SSA) to the RMP Section 9: Additional information on the submission of the results of studies in the pharmacovigilance plan and on educational materials Section 10 Additional information on RMP Summaries

Other editorial changes in various sections

3.0 Update: submission via eCTD (section 10) dst

2.0 Additional information on submission via Swissmedic Portal; delivery type dst

"communication" (section 10)