Overview
Pharmacovigilance and Regulatory Affairs services in Iceland
Insuvia assists pharmaceutical and biotechnology companies in Iceland with Pharmacovigilance and Regulatory Affairs services that comply with EU obligations and Icelandic national regulations. We provide solutions for both new and established products.
We provide advisory on national PV/RA obligations, appoint an Icelandic PV contact person, and perform screening of Icelandic publications and journals for safety data. Our team also manages marketing authorisation in Iceland and ensures maintenance of regulatory compliance.
Services in Iceland
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 Iceland
Pharmacovigilance
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Is an LPPV Required in Iceland?
No, the Local Person for Pharmacovigilance is not required in IS.
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References
There is no legal requirement to appoint a local PV contact person in Iceland, the EU-QPPV residing within the EEA is sufficient.
Regulatory Affairs
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Local RA Person Requirements in Iceland
There are no specific requirements for Local RA Person in Iceland.
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Other mandatory local roles?
No additional mandatory roles in Iceland.
Authorities
National Competent Authorities in Iceland
Contact
Contact us for more information
Contact type
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