Overview
Pharmacovigilance and Regulatory Affairs services in Romania
In Romania, Insuvia delivers Pharmacovigilance and Regulatory Affairs services that comply with EU legislation and Romanian national laws. We help you navigate the country’s regulatory system at every stage of the product lifecycle.
We provide intelligence on local regulatory requirements, appoint a local contact person for pharmacovigilance, and conduct a local literature review. Our team also manages national regulatory filings and supports ongoing local RA operations in Romania.
Services in Romania
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 Romania
Pharmacovigilance
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Is an LPPV Required in Romania?
No, Local Person for Pharmacovigilance is not required in RO.
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References
According to the national legislation of Romania (Law 95/2006 with subsequent amendments, art.815 alin.5), the National Agency for Medicines and Medical Devices (NAMMD) may request the nomination of PV contact person in national level in Romania for national PV aspects who should report to EU QPPV. In practice, most of the companies nominate the local PV person voluntarily.
Regulatory Affairs
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Local RA Person Requirements
Local Regulatory person is not mandatory in Romania, but recommended. MAH should authorize a local RA person for communication with NCA.
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Other mandatory local roles?
- Pricing/Reimbursement: Local RO person seated in Romania is needed for communication with Ministry of Health. All submissions are only in Romanian language.
- Distribution to RO pharmacies must be performed by a certified wholesaler (RO seated or EU seated wholesaler), which is registered by RO NCA for submission of distribution.
Authorities
National Competent Authorities in Romania
Contact
Contact us for more information
Contact type
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