AaMEDI can assist Swiss pharmaceutical companies by finding a suitable Responsible Person (RP/FvP)
as well as Deputy Responsible Person. We have long-standing experience in FvP/RP placement.
Ask us to find experienced FvP / RP
1. Deep knowledge of Swiss pharmaceutical legislation
RP must understand and be able to apply:
• Heilmittelgesetz (HMG) – Swiss Therapeutic Products Act
• AMBV – Ordinance on Authorisations in the Medicinal Products Sector
• GDP guidelines (EU GDP 2013/C 343/01)
• Swissmedic ordinances and guidelines
• Requirements for import, export, wholesale and distribution
2. Practical experience in GDP (Good Distribution Practice)
Swissmedic expects hands-on experience in:
• Storage & transport compliance
• Temperature-controlled supply chains
• Batch release for distribution
• Deviation and OOS handling
• Supplier and customer qualification
• Risk management
3. Experience in Quality Management Systems (QMS)
Competence in setting up and maintaining QMS according to:
• GDP
• ISO 9001 / ISO 13485 principles
• Document control
• Internal audits
• CAPA and change management
• Technical Quality Agreements
4. Experience with Swissmedic inspections
The RP should have:
• Participated in Swissmedic inspections
• Prepared companies for inspections
• Managed follow-up CAPAs and reports
• Communicated clearly with inspectors
5. Knowledge of medicinal product lifecycle and supply chain
• Imports into Switzerland
• Exports to EU / global markets
• Parallel trade (if applicable)
• Trade abroad (if applicable)
• Product recalls & FSCA
6. Strong understanding of pharmaceutical product types
• Prescription medicines, • OTC products
• Biologicals, biosimilars, • Medical cannabis (if relevant)
• Cold chain products, • High-risk medications
7. Experience in batch traceability & documentation retention
• Full traceability from supplier to customer
• Documentation retention of 10 years
• Serial number / batch number controls
8. Experience with complaints, deviations, and recalls
The RP is legally responsible for:
• Complaint evaluation, • Safety assessments
• Recall coordination, • Reporting to Swissmedic
9. Leadership and accountability
The RP must be able to:
• Make binding quality decisions
• Stop distribution in case of risk
• Oversee all operational steps
• Train staff
Swiss law expects the RP to have personal authority and independence.
Educational Requirements (as per AMBV)
• Pharmacist (usually strongest profile)
• Chemist, biochemist, biologist
• Medical doctor
• Engineer with pharma experience
• Equivalent scientific background plus several years of relevant experience