Swissmedic has published guidance document MU100_00_001, Requirements of the Responsible Person for Pharmacovigilance (human medicinal products), version 1.0, valid from 1 September 2026. This is the first version of the document.
The guidance sets out Swissmedic’s expectations for the Responsible Person for Pharmacovigilance (RPV) and the deputy RPV, covering appointment timing, qualifications, deputisation, specific tasks and the oversight of outsourced pharmacovigilance activities.
Scope of the Swissmedic RPV Guidance
The guidance applies to marketing authorisation holders and manufacturers of human medicinal products in Switzerland, which are obliged to have a suitably qualified RPV and a deputy.
The document does not cover:
- Responsible Persons for Haemovigilance under Art. 28 para. 1 MPLO
- Responsible Persons for Materiovigilance, the vigilance contact person under Art. 67 MedDO
Swissmedic states the objective as specifying the requirements for Swiss RPVs and their deputies clearly and transparently, so that pharmacovigilance obligations are met fully, correctly and continuously from the outset.
Legal Basis for the Swiss RPV Requirements
The guidance is built on the following provisions:
- TPA: Art. 59 on mandatory notification, the notification system and the right to notify; Art. 60 on inspections; Art. 67 para. 5 on medicinal product information
- MPLO: Art. 12 para. 1 let. d on the appointment of a person responsible for pharmacovigilance
- TPO: Art. 28 and 29 on medicinal product information; Art. 60 on periodic reports; Art. 61 and 62 on mandatory notification and notification timelines; Art. 64 on the duration of mandatory notification; Art. 65 on the notification system; Art. 66 on the content and form of notifications and GVP
The RPV is designated by the marketing authorisation holder or manufacturer under Art. 65 para. 3 TPO and is responsible for fulfilling the obligation to report adverse drug reactions.
The Swiss Pharmacovigilance Notification System
Companies that manufacture therapeutic products or distribute ready-to-use medicinal products in Switzerland must establish and operate a notification system for medicinal product safety. The system must be incorporated into a quality management system and must meet the requirements of Art. 59 TPA and Art. 60, 61, 62, 64, 65 and 66 TPO together with Annex 3 TPO. Swissmedic states that this means the EMA GVP requirements in Module I apply in full.
The core functions of the system are:
- Central recording and archiving by the marketing authorisation holder or manufacturer of all safety-related information subject to mandatory notification
- Continuous assessment of incoming pharmacovigilance data with regard to new or changed risks
- Introduction and monitoring of risk minimisation measures where the assessment of the data makes this necessary
- Timely communication to Swissmedic, through the designated notification systems, of all information subject to mandatory notification, in particular individual case reports originating in Switzerland from all sources and safety signals
RPV Appointment Timing and Duration of the Notification Obligation
The temporal scope of the RPV’s responsibility is therefore not limited to the period during which the marketing authorisation or establishment licence remains valid, but extends for as long as the statutory notification obligation continues.
Timing of the Appointment
The RPV and the deputy must have been appointed and be available at the point an application for an establishment licence with market release is submitted. Swissmedic identifies this as a licensing requirement and states that the application cannot be approved where the condition is not met.
The obligation to notify Swissmedic of safety-related information exists from the time the marketing authorisation application is submitted. The regulatory responsibility of the RPV therefore begins before the marketing authorisation is issued, under Art. 12 para. 1 let. d MPLO in conjunction with Art. 61 and Art. 64 TPO.
Duration of the Notification Obligation
Art. 64 TPO sets the duration of the notification obligation as running until the expiry date of the last batch supplied. Swissmedic states that compliance must be ensured by the RPV of the manufacturer or marketing authorisation holder irrespective of whether the authorisation or establishment licence remains in force, including after it is no longer valid.
All safety-related information must continue to be collected, assessed and, where necessary, notified until that point. Only then can the role be eliminated or adjusted, provided no further regulatory obligations exist.
RPV Qualification Requirements
Swissmedic derives two qualification requirements from Art. 12 para. 1 let. d MPLO:
- Specific specialist knowledge. Sufficient theoretical and practical specialist knowledge in pharmacovigilance and sound knowledge of Swiss legislation on medicinal product safety. This can be demonstrated by participation in recognised continuing education programmes or courses on EU and/or Swiss pharmacovigilance regulations, or by several years of relevant professional experience.
- Language skills. Fluency in at least one official Swiss language, which Swissmedic describes as essential for correct processing of safety-related information, communication with the Agency and review of documents. A reliable, quality-assured translation process must be in place for pharmacovigilance-relevant documentation and communication.
Beyond the two formal qualification criteria, the guidance requires the RPV and deputy to demonstrate appropriate professional qualifications, sufficient time available for the role, clearly defined responsibilities and the necessary organisational integration.
Deputisation Rules for the RPV
A qualified deputy must always be appointed to maintain the functioning of the notification system and ensure communication with Swissmedic. The guidance sets out that:
- The deputy must be able to assume the tasks of the primary Responsible Person without interruption and in full
- All qualification requirements applicable to the RPV apply equally to the deputy
- The deputisation rules must be documented in writing and must define how responsibilities, handovers and communication channels are regulated, so that pharmacovigilance processes remain compliant at all times
Specific Tasks of the RPV
Swissmedic lists the following tasks for the RPV and deputy:
- Central pharmacovigilance contact for Swissmedic. Replying comprehensively, precisely and promptly to all Agency enquiries, in particular on potential or confirmed product risks, including active cooperation during Swissmedic inspections.
- Provision of contact details. The RPV name, telephone number and e-mail address must be provided to Swissmedic immediately on request at all times.
- Monitoring compliance of submitted pharmacovigilance documents. Ensuring that ICSRs, safety signals and associated risk minimisation measures are submitted on time, in full and in high quality.
- Implementation of risk minimisation measures in Switzerland. Ensuring implementation of all measures required by Swissmedic or defined in the RMP, with reference to the guidance document RMP ICH E2E Information for submission HMP.
- Long-term retention of pharmacovigilance data. Unless otherwise specified by the company, ensuring orderly archiving of all pharmacovigilance-relevant documents and datasets for at least 10 years after expiry of the medicinal product authorisation in Switzerland.
- Organisation and provision of pharmacovigilance training. Ensuring that all employees of the marketing authorisation holder connected to medicinal product safety receive adequate initial training and regular refresher courses.
- Setting up and maintaining a local pharmacovigilance QMS. Ensuring a documented, functional QMS covering standard operating procedures, training documentation, deviation and CAPA management, and regular audits.
Outsourcing Pharmacovigilance to External Service Providers
The RPV and deputy do not have to be employed directly by the company, and their place of residence does not have to be in Switzerland. The language requirement in section 5.1.3 applies regardless of where the person is based.
Where pharmacovigilance tasks are delegated to an external third party or organisation, in whole or in part, responsibilities must be set out in writing in all cases under Art. 65 para. 3 TPO and Art. 12 para. 2 MPLO. The written arrangement must define the delegated activities, the interfaces, the notification obligations to be fulfilled, and the documentation and data security requirements.
Swissmedic expects a structured, verifiable oversight process covering at least:
- Regular performance monitoring, including key performance indicators, quality of notifications and adherence to time limits
- Documented audits
- Quality reviews
- Clear escalation and communication channels
- Assurance of the service provider’s qualifications, including in the event of staff changes
- Verification that contractually agreed tasks are performed in full, for example ICSR notifications, signal reports and PSUR submissions
Overall responsibility for pharmacovigilance remains with the marketing authorisation holder even where operational tasks are outsourced.
Impact on Marketing Authorisation Holders and Manufacturers
These requirements have several practical consequences for marketing authorisation holders and manufacturers, particularly in relation to licensing, continuity of pharmacovigilance responsibilities, outsourcing and inspection readiness.
- The requirement for a qualified deputy able to take over without interruption and in full, holding the same qualifications as the RPV, makes deputy qualification records and written deputisation rules directly inspectable items.
- Appointment before submission of an establishment licence application with market release is a licensing condition, which brings RPV recruitment and qualification into the licensing timeline rather than the post-authorisation phase.
- The notification obligation running to the expiry date of the last batch supplied means the RPV role must be maintained beyond withdrawal of an authorisation or licence, which affects role elimination planning and archiving arrangements.
- Companies using external pharmacovigilance service providers require a documented oversight process containing the six elements listed by Swissmedic, together with a written definition of delegated activities, interfaces, notification obligations and data security requirements.
- Local pharmacovigilance QMS elements named by Swissmedic, namely SOPs, training records, deviation and CAPA management and audits, define the documentation set expected at inspection.
Summary
Swissmedic guidance MU100_00_001 consolidates the requirements applying to the Responsible Person for Pharmacovigilance and the deputy for human medicinal products in Switzerland. It confirms that the notification system must sit within a quality management system and meet EMA GVP Module I in full, sets appointment of the RPV and deputy as a condition for approval of an establishment licence application with market release, applies identical qualification requirements to the RPV and the deputy, and requires the notification obligation to be maintained until the expiry date of the last batch supplied.
For outsourced pharmacovigilance activities, the guidance requires written definition of the delegated scope and a structured, verifiable oversight process, with overall responsibility remaining with the marketing authorisation holder. The document is version 1.0 and has been valid since 1 September 2026.
