Service
Pharmacovigilance & drug-safety counsel.
Marketing-authorisation holders must operate a pharmacovigilance system to monitor and report the safety of their medicines. The firm covers the legal dimension of that system: safety-reporting obligations under Swiss HMG/AMBV and EU GVP, QPPV and safety-data-exchange agreements (SDEA), signal-management and CAPA legal review, and audit and inspection readiness.
Who this is for
- Marketing-authorisation holders and affiliates operating Swiss or EU PV systems.
- Companies outsourcing the QPPV interface or safety-data exchange.
- Sponsors structuring safety-data exchange with development or distribution partners.
What's included
- Safety-reporting obligations: the duty of anyone who manufactures or distributes ready-to-use therapeutic products to operate a reporting system and to report adverse effects and incidents to Swissmedic (Art. 59 HMG), aligned with the parallel EU GVP reporting framework.
- Responsible-person and QPPV arrangements: the Swiss pharmacovigilance responsible person (Art. 12 AMBV), who need not belong to the company and whose responsibilities must be set out in writing, and the EU QPPV role, including the contracts where either function is outsourced.
- Safety-data-exchange agreements: drafting and negotiating SDEAs that allocate collection, assessment and reporting duties, and their timelines, between licensors, licensees and co-marketing partners.
- Signal-management and CAPA legal review: legal review of signal-detection and corrective-and-preventive-action processes and their documentation; the underlying scientific assessment remains with the marketing-authorisation holder.
- Audit and inspection readiness: preparing the pharmacovigilance system and its contracts for partner audits and authority inspections.
- Swiss–EU alignment: one pharmacovigilance system that satisfies HMG/AMBV duties and EU GVP in parallel, rather than two disconnected compliance tracks.
How it works
- System review. The firm reviews the client's pharmacovigilance system against the applicable Swiss and EU duties.
- Agreements. The firm drafts or reviews QPPV and safety-data-exchange agreements (SDEA).
- Reporting. The firm advises on safety-reporting obligations and timelines.
- Signal & CAPA. The firm provides legal review of signal-management and corrective-action processes.
- Inspection readiness. The firm prepares the client for audits and authority inspections.
Indicative pricing
Subscription + fixed-fee modules
from CHF 5,500 / month
Modules CHF 5,000 to 18,000; per-country local-contact-person coverage from CHF 700 / month.
Indicative starting prices, net and exclusive of Swiss MWST (VAT) where applicable; final fee per written engagement letter.
Frequently asked questions
- What is a QPPV and is one required?
- A Qualified Person Responsible for Pharmacovigilance (QPPV) is the individual accountable for a marketing-authorisation holder's pharmacovigilance system in the EU; Swiss law has a corresponding responsible-person concept (Art. 12 AMBV). The firm advises on the role and drafts the contractual arrangements where it is outsourced; the specific statutory duties are confirmed at engagement.
- What is a safety-data-exchange agreement (SDEA)?
- When two or more companies share responsibility for a product (for example a licensor and licensee, or co-marketing partners), an SDEA allocates who collects, assesses and reports safety data, and on what timelines. The firm drafts and negotiates these agreements so the obligations are unambiguous.
- How do Swiss and EU pharmacovigilance duties relate?
- A company active in both markets runs one pharmacovigilance system that must satisfy Swiss therapeutic-products law and EU good pharmacovigilance practices in parallel. The firm aligns the legal obligations across both rather than treating them separately.
- Who must report adverse drug reactions in Switzerland?
- Anyone who manufactures therapeutic products or distributes ready-to-use therapeutic products must operate a reporting system and report adverse effects and incidents to Swissmedic (Art. 59 HMG). For a marketing-authorisation holder this means the reporting system, its responsible person and the contracts behind it are statutory obligations, not optional quality measures. The firm reviews that legal architecture; the clinical case assessment remains with the company's pharmacovigilance function.