How do you set up regulatory and quality in Switzerland, from the Swissmedic license to the Responsible Person (FvP)?
We support pharma and biotech companies in Switzerland on regulatory and quality, from the Swissmedic license to the Responsible Person (FvP). The Responsible Person decides on the release of every batch and is named in the license.
Overview
What does Switzerland require of manufacturers, importers and wholesalers?
Swissmedic establishment licenses under the TPA and the MPLO · Responsible Person (FvP) · technical release and market release · team in Basel
Last updated: November 6, 2026
Anyone who manufactures, imports or distributes medicinal products at wholesale in Switzerland needs an establishment license from Swissmedic (TPA Art. 5, 18 and 28). Each of these licenses requires a Responsible Person who carries out direct technical supervision of the facility (MPLO Art. 3(1)(c), Art. 5 and Art. 11).
- Two releases, two roles. The manufacturer's Responsible Person decides on the technical release of a batch and issues a batch certificate (MPLO Art. 7); the marketing authorization holder's Responsible Person decides on market release before the batch is placed on the market (MPLO Art. 13).
- The license names the person. It lists the Responsible Person and cannot be transferred to other persons or other sites (MPLO Art. 40); for every change to its content, the holder files an application with Swissmedic (MPLO Art. 41(1)).
- Independence is part of the requirement. The Responsible Person may not sit on a supervisory body of the company and decides on the release or rejection of batches independently of the management (MPLO Art. 5(6) and Art. 17(6)); in Swissmedic's interpretation, a CEO therefore cannot be the Responsible Person (I-SMI.TI.17d, section 5.4).
- Part time is possible, with a floor. Where the scope and nature of the facility allow it, the Responsible Person works part time, with responsibilities set out in writing and a defined minimum presence (MPLO Art. 5(7)); Swissmedic expects at least 10% of a full-time position and no more than five mandates (I-SMI.TI.17d, sections 5.6.2 and 5.6.4.1).
- Imported products need a recognized GMP control system. The manufacturer must hold a manufacturing license from a country whose GMP control system Swissmedic considers equivalent, or manufacture under the Swiss GMP rules (MPLO Art. 11(1)(i)).
Services
How we support you
License application and changes
Application for an establishment license for manufacturing, import, wholesale or trade in foreign countries with the evidence under MPLO Art. 3, 11 or 21: quality assurance system, job descriptions and organization charts, documentation system. Plus change applications under Art. 41(1) and notification of significant changes to premises, equipment or processes under MPLO Art. 41(2).
Absence and change of the Responsible Person
Rules for a longer absence: the deputy acting on behalf of the Responsible Person for up to four months, the deputy's written acceptance of full responsibility, and the application to Swissmedic for a change of Responsible Person if the absence lasts longer (I-SMI.TI.17d, section 8).
How we work together
What it comes down to
In Switzerland, the Therapeutic Products Act (TPA, German HMG) and the Medicinal Products Licensing Ordinance (MPLO, German AMBV) govern who may manufacture, import and distribute medicinal products. Swissmedic grants the licenses, and each one requires a Responsible Person (in German fachtechnisch verantwortliche Person, FvP). This page covers medicinal products; medical devices and IVDs fall under separate law.
| Activity | License | What the Responsible Person decides or ensures |
|---|---|---|
| Manufacturing | TPA Art. 5, MPLO Art. 3 | Technical release of every batch with a batch certificate (MPLO Art. 7) |
| Import, wholesale, export | TPA Art. 18 and 28, MPLO Art. 11 | Wholesale, import and export in line with the GDP rules (MPLO Art. 17(2)) |
| Market release as marketing authorization holder | MPLO Art. 12, on top of the import or wholesale license | Market release before placing on the market (MPLO Art. 13) |
| Trade in foreign countries | TPA Art. 18, MPLO Art. 21 | Proper conduct of the trade (MPLO Art. 23) |
Anyone seeking a marketing authorization in Switzerland needs a manufacturing, import or wholesale license of their own and a domicile, registered office or branch in Switzerland (TPA Art. 10(1)(b) and (c)). A marketing authorization therefore always comes with a licensed facility and a Responsible Person.
As rules of Good Manufacturing Practice, the MPLO declares the EU GMP Guide (EudraLex Volume 4) and the guidelines under the PIC Convention applicable (Annex 1); as rules of Good Distribution Practice, the European Commission guidelines of November 5, 2013 (Annex 4). Teams that know GMP and GDP under EU law will recognize the content; the license, the roles and the interpretation are Swiss law.
From Basel. Our Swiss location is Entourage Pharma Consulting AG at Hardstrasse 1 in Basel. For facilities in Basel-Stadt and Basel-Landschaft, the Regional Medicines Inspectorate of Northwestern Switzerland carries out the inspections that Swissmedic delegates to the cantons; it also covers Aargau, Bern, Lucerne and Solothurn.
For medical devices and IVDs, Switzerland has separate ordinances with a Swiss authorized representative and registration in swissdamed; see International Market Access. The Qualified Person under EU law is covered under QP on Demand.
Our approach
Our approach
Step
Result
Define activities
Which license the facility needs (manufacturing, import, wholesale, export, trade in foreign countries) and at which sites.
Appoint the Responsible Person
A Responsible Person whose training, experience, language and place of residence meet the MPLO and I-SMI.TI.17d, with a deputy and powers set out in writing.
File the application
A complete application to Swissmedic with the evidence under MPLO Art. 3 or Art. 11.
Pass the inspection
The inspection in which the competent authority checks whether the requirements are met (TPA Art. 6(2), Art. 19(3) and Art. 28(4)).
Keep the license
Change applications and notifications under MPLO Art. 41 and the periodic inspections under MPLO Art. 42.
Common pitfalls
Where projects commonly fail
An experienced EU QP is planned in as Responsible Person without checking language and place of residence.
The Responsible Person must speak an official language of the canton where the licensed site is located and, as a guideline, should live no more than two hours' travel from the site (I-SMI.TI.17d, sections 5.5 and 5.6.1).
The batch is released from a home in the EU.
Swissmedic accepts technical release or market release without on-site presence only under conditions, and only from a residence of the Responsible Person in Switzerland (I-SMI.TI.17d, section 5.6.1.1).
The release decision is delegated to a unit outside the Responsible Person's supervision.
In Swissmedic's interpretation, release decisions are taken by the Responsible Person personally or under their direct supervision and responsibility, and direct supervision of the facility cannot be delegated (I-SMI.TI.17d, section 7).
The Responsible Person is absent for a long time, and nobody applies for a change.
The deputy can act on behalf of the Responsible Person for up to four months; if the absence lasts longer or is expected to, a change of Responsible Person must be requested from Swissmedic (I-SMI.TI.17d, section 8).
The presence time is in the contract but in no attendance record.
Swissmedic expects the actual hours of presence to be verifiable, and more on-site presence when inspections show many deficiencies (I-SMI.TI.17d, section 5.6.2).
Regulatory Affairs
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA; HMG), SR 812.21, status January 1, 2025, Art. 5, 6, 10, 18, 19, 28, 60: https://www.fedlex.admin.ch/eli/cc/2001/422/en
- Ordinance on Licensing in the Medicinal Products Sector (Medicinal Products Licensing Ordinance, MPLO; AMBV), SR 812.212.1, status March 15, 2025, Art. 3, 5, 6, 7, 11, 12, 13, 17, 18, 21, 23, 40, 41, 42, 62, Annexes 1 and 4: https://www.fedlex.admin.ch/eli/cc/2018/786/en
- Swissmedic, technical interpretation I-SMI.TI.17d "Fachtechnisch verantwortliche Person", version 7.0, valid from August 26, 2024: https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/bewilligungen_zertifikate/betriebsbewilligungen/inspektorate.html
- Swissmedic, list BW105_00_002 "Liste Länder mit anerkanntem GMP Kontrollsystem", version 4.0, valid from August 12, 2026: https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/bewilligungen_zertifikate/betriebsbewilligungen/merkblaetter.html
- Regional Medicines Inspectorate of Northwestern Switzerland (RHI NW): https://www.rhinw.ch/
- Directive 2001/83/EC (Community code relating to medicinal products for human use), Art. 51
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Projects from this industry
What we have worked on in this industry
Latest insights
All insights →Regulations & standards considered
- Therapeutic Products Act TPA (HMG, SR 812.21), Art. 5 and 6 (manufacturing license), Art. 10(1)(b) and (c) (marketing authorization application only with an establishment license and a seat in Switzerland), Art. 18 and 19 (import, export, trade in foreign countries), Art. 28 (wholesale), Art. 60 (inspections)
- Medicinal Products Licensing Ordinance MPLO (AMBV, SR 812.212.1), Art. 3 to 7 (manufacturing license, technical supervision, requirements for the Responsible Person, technical release)
- MPLO Art. 11 to 13, 17 and 18 (import and wholesale, market release by the marketing authorization holder's Responsible Person)
- MPLO Art. 39 to 42 (licensing procedure, content of the license, changes, periodic inspections) and Art. 62 (powers of inspectors)
- MPLO Annex 1 (rules of Good Manufacturing Practice: EU GMP Guide, EudraLex Volume 4, and PIC/S) and Annex 4 (rules of Good Distribution Practice)
- Swissmedic, technical interpretation I-SMI.TI.17d "Fachtechnisch verantwortliche Person" (Responsible Person), version 7.0, valid from August 26, 2024
Related topics
QP on Demand →
The Qualified Person under EU law and batch release for the German and European market
International Market Access →
Medical devices and IVDs in Switzerland: CH-REP, MepV, IvDV and swissdamed
Good Distribution Practice →
Good distribution practice in the supply chain that market release relies on
Inspection Readiness →
Preparing for GMP and GDP inspections, mock inspection and support on the day
Health Authority Interaction →
Applications and variations with Swissmedic and other authorities
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