Overview
Pharmacovigilance and Regulatory Affairs services in Lithuania.
Insuvia works with pharmaceutical and biotechnology companies in Lithuania to deliver Pharmacovigilance and Regulatory Affairs services that meet both EU legislation and Lithuania’s national requirements. Our team combines European regulatory expertise with in-depth local knowledge to help you maintain compliance at every stage of the product lifecycle.
We provide guidance on national PV and RA requirements, appoint a local person responsible for pharmacovigilance, and carry out national literature reviews to capture safety information. Our team also manages regulatory submissions, variations, and renewals while maintaining ongoing regulatory affairs support to ensure compliance throughout the product lifecycle in Lithuania.
Services in Lithuania
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 Lithuania
Pharmacovigilance
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Is an LPPV Required in Lithuania?
No, Local Person for Pharmacovigilance is not required in LT.
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References
Based on the local Law on Pharmacy of Lithuania, the State Medicines Control
Agency (SMCA) may or may not request the nomination of a PV contact person at a national
level in LT.
Regulatory Affairs
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Local RA Person Requirements in Lithuania
There are no specific requirements for local Regulatory Affairs Person.
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Other mandatory local roles?
Price declaration is to be completed in iDrug platform where an account is needed. This activity can be oursourced.
Authorities
National Competent Authorities in Lithuania
Contact
Contact us for more information
Contact type
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