Overview
Pharmacovigilance and Regulatory Affairs services in Norway
Insuvia works with life science companies in Norway to provide Pharmacovigilance and Regulatory Affairs solutions that meet EEA obligations and Norwegian regulations. Our experts combine local insight with European compliance knowledge.
We deliver PV/RA intelligence, provide a country-level PV contact, and conduct local literature surveillance. Additionally, we oversee coordination of regulatory procedures and provide national RA services for compliance in Norway.
Services in Norway
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 Norway
Pharmacovigilance
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Is an LPPV Required in Norway?
No, Local Person for Pharmacovigilance is not required in NO.
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References
There is no legal requirement to appoint a local PV contact person in Norway, the EU-QPPV residing within the EEA is sufficient.
Regulatory Affairs
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Local RA Person Requirements
Local Regulatory Affairs is not required in Norway.
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Other mandatory local roles?
No other mandatory roles in Norway.
Authorities
National Competent Authorities in Norway
Contact
Contact us for more information
Contact type
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