Overview
Pharmacovigilance and Regulatory Affairs services in Hungary
In Hungary, Insuvia offers Pharmacovigilance and Regulatory Affairs services that meet EU and Hungarian requirements. We work with you to navigate the country’s regulatory environment smoothly and effectively.
Our services include guidance on local regulatory requirements, provision of a local contact person for pharmacovigilance, and local journals surveillance. We also support new MAAs in Hungary and provide ongoing local regulatory maintenance for compliance.
Services in Hungary
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 Hungary
Pharmacovigilance
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Is an LPPV Required in Hungary?
Yes, the Local Person for Pharmacovigilance is required in HU.
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LPPV Requirements
The local PV person in Hungary must:
- Have a degree in life science or chemistry or chemical engineering;
- Be trained in pharmacovigilance (provided or acknowledged by the EU
QPPV).
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References
The Regulation of Ministry of Human Resources on pharmacovigilance of human medicinal products (15/2012) set a legal obligation for MAHs to appoint a national PV contact person in Hungary in case the residence of the responsible person for Pharmacovigilance (EU QPPV) is outside of Hungary
Regulatory Affairs
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Local RA Person Requirements in Hungary
Local Regulatory Affairs person is required in Hungary.
All comunication should be done in local language. A local Hungarian contact is required who can keep in touch with HU Authority and that can use Hungarian web portal („Cégkapu”, Company e-gate) because that is a validation criteria.
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Other mandatory local roles?
No additional mandatory roles in Hungary.
Authorities
National Competent Authorities in Hungary
Contact
Contact us for more information
Contact type
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