What is a QPPV and is one required?

Yes, in the EU: a marketing-authorization holder must have a Qualified Person Responsible for Pharmacovigilance (QPPV) permanently and continuously at its disposal, residing and operating in the EU and responsible for its pharmacovigilance system (Art. 104(3) Directive 2001/83/EC). Swiss law has a corresponding responsible-person requirement (Art. 12 AMBV). GAWEL Legal advises on both roles and drafts the contractual arrangements where either is outsourced.

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. GAWEL Legal 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. GAWEL Legal 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-authorization holder this means the reporting system, its responsible person and the contracts behind it are statutory obligations, not optional quality measures. GAWEL Legal reviews those obligations and contractual arrangements; the clinical case assessment remains with the company's pharmacovigilance function.

Pharmacovigilance and drug safety

GAWEL Legal advises on a marketing-authorization holder's pharmacovigilance system under the HMG, AMBV and EU GVP, on a retainer. The retainer covers safety-reporting obligations, QPPV and safety-data-exchange agreements (SDEAs), signal-management and CAPA review, and audit and inspection readiness.

Discuss pharmacovigilance duties View scope

Safety responsibilities and agreements

Authorization holder: Pharmacovigilance system
Responsible person: Swiss role and EU QPPV
Partners: Safety-data-exchange agreements

Legal review of obligations and contracts; scientific assessment remains with the authorization holder.

Who this is for

Marketing-authorization holders and affiliates operating Swiss or EU pharmacovigilance systems
Companies outsourcing the QPPV interface or safety-data exchange
Sponsors structuring safety-data exchange with development or distribution partners

Scope

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-authorization holder.
Audit and inspection readiness:
preparing the pharmacovigilance system and its contracts for partner audits and authority inspections
Swiss and EU alignment:
coordinating HMG/AMBV duties and EU GVP requirements within one pharmacovigilance system

How the work proceeds

System review The client's pharmacovigilance system is reviewed against the applicable Swiss and EU duties.
Agreements QPPV and safety-data-exchange agreements (SDEA) are drafted or reviewed.
Reporting Advice covers safety-reporting obligations and timelines.
Signal & CAPA Signal-management and corrective-action processes receive legal review.
Inspection readiness Legal preparation addresses audits and authority inspections.

Fees

Retainer + fixed-fee modules

Ongoing advice runs on a retainer, with fixed-fee modules for defined agreements and reviews.

Questions

What is a QPPV and is one required?: Yes, in the EU: a marketing-authorization holder must have a Qualified Person Responsible for Pharmacovigilance (QPPV) permanently and continuously at its disposal, residing and operating in the EU and responsible for its pharmacovigilance system (Art. 104(3) Directive 2001/83/EC). Swiss law has a corresponding responsible-person requirement (Art. 12 AMBV). GAWEL Legal advises on both roles and drafts the contractual arrangements where either is outsourced.
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. GAWEL Legal 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. GAWEL Legal 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-authorization holder this means the reporting system, its responsible person and the contracts behind it are statutory obligations, not optional quality measures. GAWEL Legal reviews those obligations and contractual arrangements; the clinical case assessment remains with the company's pharmacovigilance function.

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Briefly describe the matter and the legal advice you need.

Discuss a pharmacovigilance mandate