Overview
Pharmacovigilance and Regulatory Affairs services in Finland
Insuvia partners with pharmaceutical and biotech companies in Finland to deliver PV and RA services aligned with EU legislation and Finland’s regulations. We help you maintain compliance at every stage of the product lifecycle.
We ensure analysis of national PV/RA requirements, appoint a local pharmacovigilance representative, and conduct a national medical literature review. In addition, we manage regulatory submissions in Finland and provide national RA coordination.
Services in Finland
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 Finland
Pharmacovigilance
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Is an LPPV Required in Finland?
There are no specific requirements for the local PV person in Finland.
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References
- According to national legislation (Medicines Act 30 c §), the Finnish
Medicines Agency (Fimea) may request the MAH to designate a national PV contact person in Finland, who should report to the EU-QPPV. - Fimea recommends the MAH to nominate a contact person for pharmacovigilance issues at national level. The contact person does not need to hold a specific medical degree, but a good knowledge of pharmacovigilance practices and regulatory requirements would be beneficial. If the MAH does not nominate the contact person, all individual
case safety report (ICSR) related communication will be directed to the EU
QPPV.
- According to national legislation (Medicines Act 30 c §), the Finnish
Regulatory Affairs
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Local RA Person Requirements in Finland
RA role in Finland is not mandatory, but need to fill in contact detail forms for MAs (https://fimea.fi/en/about_us/forms)
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Other mandatory local roles?
At least experts in applying for reimbursement needed in case of Rx medicines, but not requirement to have this person physically seated in Finland.
Authorities
National Competent Authorities in Finland
Contact
Contact us for more information
Contact type
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