Overview
Pharmacovigilance and Regulatory Affairs services in Austria
In Austria, Insuvia supports pharmaceutical and biotech companies with PV and RA solutions that meet EU directives and Austrian regulations. We help you navigate complex compliance landscapes effectively.
We deliver guidance on local regulatory requirements, provision of a local contact person for PV, and local literature-based safety monitoring. We also manage national submissions and renewals while providing continuous regulatory license support in Austria.
Services in Austria
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 Austria
Pharmacovigilance
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Is an LPPV Required in Austria?
No, Local Person for Pharmacovigilance is not required in AT. In practice,
most companies nominate the local PV person in Austria voluntarily -
References
According to local law (§ 75i (6) AMG), the Austrian Federal Office for Safety in Health Care (BASG) has the option to request the nomination of
a PV contact person at a national level in Austria from the MAH.
Regulatory Affairs
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Local RA Person Requirements in Austria
Local RA person is not required in Austria. However, MAH must sign a contract with National Medicines Verification Organization. EU contact person for verification incidents should be assigned.
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Other mandatory local roles?
There are no other mandatory roles required.
Authorities
National Competent Authorities in Austria
Contact
Contact us for more information
Contact type
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