As we continue exploring pharmacovigilance (PV) requirements in the DACHL region, this second part of the blog series covers the local roles and obligations in Switzerland and Liechtenstein. While part 1 focused on Germany and Austria, this post highlights the unique regulatory landscapes of these non-EU and EEA territories, and what Marketing Authorization Holders (MAHs) need to be aware of when operating in these markets.
Pharmacovigilance requirements in Switzerland
Switzerland, although located in the center of Europe, is not a member of the EU or the EEA. Consequently, its regulatory framework for medicinal products deviates from the EU model. The national competent authority, Swissmedic, independently oversees some pharmacovigilance activities, such as signal management, irrespective of EMA approvals.
Swiss Legal Framework
The key legislation governing pharmacovigilance in Switzerland is the Therapeutic Products Act (TPA) (German: Heilmittelgesetz), which requires the appointment of a Local Person Responsible for Pharmacovigilance (LPPV).
Responsibilities of the LPPV
The LPPV is responsible for:
- Oversight of the pharmacovigilance system
- Ensuring timely and accurate adverse drug reaction (ADR) reporting
- Preparing required certificates and PV documents for Swissmedic
While the LPPV does not need to be based in Switzerland, Swissmedic must be informed of their contact details. If the LPPV is external to the MAH, a formal job description must outline their responsibilities.
Contact and availability
- The LPPV or a deputy must be reachable during business hours on Swiss working days.
- It is recommended that an emergency on-call service be established for outside business hours.
Key takeaways
- Mandatory LPPV: A designated LPPV is legally required.
- Location Flexibility: The LPPV can reside outside Switzerland.
- Swissmedic Registration: Swissmedic must be notified of the LPPV.
ProPharma insight: Our PV experts are familiar with Swissmedic’s requirements and can serve as your LPPV or support your internal nominee to ensure full compliance.
FAQs – Switzerland
Does the LPPV need to be a Swiss resident?
No, but their contact details must be available to Swissmedic.
Can the LPPV be external to the MAH?
Yes, provided with a clear job description that is in place.
When should the LPPV be available?
The LPPV must be reachable during Swiss business hours, with 24/7 coverage recommended.
Pharmacovigilance requirements in Liechtenstein
Overview
Liechtenstein, though not a member of the EU, is part of the European Economic Area (EEA). It has unique pharmacovigilance procedures due to its integration with both Swissmedic and Austria’s BASG, depending on the marketing authorization pathway.
Regulatory framework
Local legislation is governed by the Heilmittelgesetz (HMG), largely reflecting Swiss regulations. There is no explicit requirement for a Local Person Responsible for Pharmacovigilance under Liechtenstein law. Instead, the obligations vary based on how the product is registered.
PV obligations by product type
- Centrally Authorized Products (EMA)
- ADR reporting follows Austrian procedures.
- Products under Swiss Law (Art. 4 HMG)
- ADRs must be reported via Swissmedic.
- Products via Austrian MRP/DCP, if Liechtenstein is explicitly mentioned in the application
- PV activities follow BASG requirements.
MAHs must comply with the legal framework of the jurisdiction their product is registered under—be it Swiss or Austrian.
Key takeaways
- No Specific LPPV Role: Liechtenstein does not mandate a national LPPV.
- Compliance Follows Authorization Route: Depending on how your product is registered, Swiss or Austrian PV rules will apply.
- Coordination Is Key: Efficient pharmacovigilance management in Liechtenstein often involves collaboration with neighboring regulatory authorities.
ProPharma insight: Our team has deep knowledge of both Swiss and Austrian PV systems and can help ensure your Liechtenstein operations are fully compliant regardless of authorization pathway.
FAQs – Liechtenstein
Is an LPPV required for Liechtenstein?
No, but if registered under Swiss law, an LPPV must be appointed for Switzerland. If authorized under EU law, obligations fall under Austrian jurisdiction.
Where do I report adverse events?
ADR reporting is based on your product’s registration—either to Swissmedic or BASG.
What if I market under both Swiss and Austrian procedures?
You must ensure that your PV system aligns with both frameworks and reporting obligations.
Need support with LPPV or regional PV compliance in DACHL?
The regulatory requirements in Switzerland and Liechtenstein are distinct and highly dependent on the route of marketing authorization. Appointing an LPPV is a legal requirement in Switzerland, while in Liechtenstein, it is determined by the applicable jurisdiction (Swiss or Austrian). Understanding these frameworks is essential for ensuring compliance, minimizing risk, and maintaining efficient PV systems.
ProPharma’s network of local PV experts is ready to support your business. From acting as your official LPPV in Switzerland to advising on cross-border reporting structures in Liechtenstein, we provide seamless regulatory support tailored to your needs. Contact us to learn how ProPharma can support your pharmacovigilance operations across the DACHL region.
