The Responsible Person (FvP, fachtechnisch verantwortliche Person) is the figure who guarantees, in Switzerland, the quality of medicinal products and compliance with therapeutic products legislation in every company holding a Swissmedic establishment licence: manufacturing sites, importers and wholesalers. It is the Swiss counterpart of the EU Qualified Person, but with a broader scope of responsibility and its own requirements, defined by the Medicinal Products Licensing Ordinance (MPLO) and specified in Swissmedic technical interpretation I-SMI.TI.17. Anyone working with Swiss partners — or aiming for this role — needs to know its duties, requirements and operational constraints in detail.
Who is the Responsible Person (FvP)?
Every establishment licence issued by Swissmedic (manufacturing, importation, wholesale, export) requires a named FvP. The Responsible Person exercises direct technical supervision over the company: they ensure medicinal products are handled appropriately, answer for the quality of the products manufactured or distributed, and verify that the company operates in compliance with therapeutic products legislation. Unlike the EU model — where the Qualified Person (GMP) and the Responsible Person (GDP) are separate figures — Switzerland follows a single logic: the FvP covers the scope of the licence, whether manufacturing, importation or wholesale distribution.
The role is personal and named: the FvP is stated on the establishment licence and any change must be notified to and approved by Swissmedic. That is why, in an inspection by the regional inspectorate or Swissmedic, the first question is not "do you have a quality system?" but "who is your FvP, how present are they, and how do they decide?". The robustness of the FvP mandate is, in every respect, as much a compliance requirement as an SOP or a batch record.
Legal basis: TPA, MPLO and technical interpretation I-SMI.TI.17
The regulatory framework has three levels:
- TPA (Therapeutic Products Act, SR 812.21): establishes the licensing obligation and product responsibility;
- MPLO (Medicinal Products Licensing Ordinance, SR 812.212.1): governs the FvP in Art. 5-6 for manufacturing and Art. 17-18 for wholesale and importation, with specific provisions for brokerage and foreign trade;
- I-SMI.TI.17: the Swissmedic inspectorate's technical interpretation (version 7.0, in force since 26 August 2024), which turns the ordinance's requirements into concrete criteria for education, experience and presence. Companies with already-approved FvPs not meeting the updated requirements were granted a 12-month transition period.
Topics like this — regulatory roles, Swissmedic requirements, EU/Switzerland differences — are the bread and butter of The Pragmatic GMP, GuideGxP's free weekly newsletter: one practical, audit-ready analysis every week, straight to your inbox. Subscribe here.
Education and experience requirements
Art. 6 MPLO requires the FvP to have the necessary technical knowledge and to be trustworthy; the education required depends on the licensed activity. I-SMI.TI.17 specifies the accepted profiles and the minimum experience, which varies with the type of company (1 to 4 years), with GMP experience required for manufacturing and batch release and GDP experience for distribution and importation.
| Licensed activity | Required education | Practical experience |
|---|---|---|
| Finished medicinal products and intermediates | Pharmacist degree | Adequate GMP experience, including batch release |
| Blood products and immunological medicinal products | University degree in medicine or natural sciences | Related experience; at least 1 year in specific-risk environments (sterile, biotech, blood products) |
| Active substances (APIs) | University degree in natural sciences | Relevant practical experience (chemical-analytical or biotechnological) |
| Radiopharmaceuticals | Radiopharmacy certificate (European Association of Nuclear Medicine) | Specific experience in the field |
| Wholesale / importation | Adequate scientific education (Art. 18 MPLO) | GDP experience in distribution |
Swissmedic may recognise other educational backgrounds if the candidate demonstrates sufficient knowledge and experience: the application dossier should therefore be built with the same care as a regulatory dossier.
Duties: direct technical supervision and batch release
The FvP's duties defined in Art. 5 MPLO and detailed in I-SMI.TI.17 cannot be delegated in their essential elements:
- Direct technical supervision of the company, with the authority to issue instructions within their field of activity;
- Technical batch release (Art. 7 MPLO), decided in full independence from company management: the FvP may not sit on the company's supervisory bodies;
- Approval of critical PQS processes: audits, deviation management, Product Quality Reviews;
- Immediate notification to Swissmedic if the company ceases, or is about to cease, its activity.
The combination of decision-making autonomy and personal responsibility makes the FvP one of the most exposed roles during an inspection: every release decision must be documented and reconstructable.
Presence, deputisation and language: the operational requirements
I-SMI.TI.17 sets operational constraints that companies and candidates often underestimate:
- Reachability: residence no more than 2 hours' travel from the site;
- Minimum time: a commitment of at least 10% of a full-time position, with regular presence at all sites, proportionate to the risks;
- Remote release: allowed only from a Swiss residence and under defined circumstances;
- Deputisation: the deputy must hold equivalent qualifications and may cover absences of up to 4 months (6 for maternity leave), beyond which a formal replacement application to Swissmedic is required;
- Language: fluent command of an official language of the canton where they operate, to communicate with authorities and staff without intermediaries — a requirement clarified precisely in version 7.0.
FvP vs EU Qualified Person: the differences you need to know
Professionals coming from the EU model should avoid three errors of perspective. First: the FvP is not a QP "under another name" — their responsibility covers the company's entire technical supervision, not just batch certification. Second: Swiss education requirements are defined by the MPLO and the Swissmedic interpretation, not by EU legislation: EU QP eligibility does not automatically translate into FvP suitability. Third: presence, reachability and language constraints are verified during inspections and licensing; a "token" FvP mandate with purely nominal presence is not defensible before the inspectorate.
GuideGxP recommendation
If you aspire to the FvP role, build your path in a verifiable way: accumulate documented GMP experience (ideally including participation in the batch release process), invest in the language of the canton and be ready to demonstrate real availability and reachability. If you are a company, assess the candidate against I-SMI.TI.17 before submitting the application to Swissmedic, and formalise in writing the dedicated time, deputisation and responsibilities. In both cases, master the heart of the role: the release decision.
To master the logic, responsibilities and documentation of batch certification — the competence closest to both QP and FvP — our Qualified Person (QP) Operational Guide – Annex 16 / Batch Release offers a complete framework, with practical examples and an audit-defensible structure.
