Overview
Pharmacovigilance and Regulatory Affairs services in Sweden
Insuvia helps pharmaceutical and biotech companies in Sweden and delivers PV and RA solutions that comply with EU legislation and Sweden’s national regulations. We help you navigate the country’s regulatory system efficiently and effectively.
We deliver country-specific PV and RA insights, appoint a national PV responsible person, and conduct local journals surveillance. In Sweden, we also coordinate national procedures and provide local RA operational support for compliance.
Services in Sweden
Local Affiliate Services with An Integrated Cross-Functional Expertise
Local Pharmacovigilance
- Local QPPV / Local Person for PV (LPPV)
- Local Literature Screening
- Local ICSR Management
- Local PV regulatory intellingence
- Implementation of aRMMs (Educational Materials, DHPC)
Local Regulatory Affairs
- Health Authority contact
- Professional advice and regulatory consulting
- New MAA & Product Approval
- Product life-cycle management
- Local Regulatory Intelligence
- Artwork review & management
- Promotional Materials review and approval
Market Access
- Regulatory Intelligence
- Pricing applications
- Consulting on national reimbursement strategy
- Reimbursement applications
- Price negotiations with national authorities
- Support with risk sharing agreements
- Support with early access programs (EAP, CUP, NPP)
QA & Compliance
- Stock management support (shortage/stock out, product recalls, quality issues)
- Management of product quality complaints (PQC)
- Consulting on local GDP requirements
- Management of serialization requirements, liaison with NMVOs
- Review of HCP engagement, HCP/events sponsorship disclosure
- Promotional Materials & Activities Compliance
Legal & Regulatory Context in Sweden
Pharmacovigilance
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Is an LPPV Required in Sweden?
No, Local Person for Pharmacovigilance is not required in SE.
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References
There is no legal requirement to appoint a local PV contact person in Sweden, the
EU-QPPV residing within the EEA is sufficient.
Regulatory Affairs
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Local RA Person Requirements
Local RA role not mandatory in Sweden.
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Other mandatory local roles?
No additional mandatory roles are required in Sweden.
Authorities
National Competent Authorities in Sweden
Contact
Contact us for more information
Contact type
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