Overview
Pharmacovigilance and Regulatory Affairs services in Slovenia
In Slovenia, Insuvia works with pharmaceutical and biotech companies to provide Pharmacovigilance and Regulatory Affairs services that align with EU law and Slovenia’s specific requirements. Our team ensures smooth compliance throughout the product lifecycle.
We ensure advisory on national PV/RA obligations, provision of an LPPV, and local literature-based safety monitoring. In addition, we manage DCP/MRP national phase implementation and oversee national RA coordination and oversight in Slovenia.
Services in Slovenia
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 Slovenia
Pharmacovigilance
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Is an LPPV Required in Slovenia?
Yes, Local Person for Pharmacovigilance is required in SI.
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LPPV Requirements
The local PV person in Slovenia must:
- Hold a medical degree, pharmacy degree, or a veterinary degree (or a
level of education, which corresponds to the law and the mentioned levelof education); - Be an individual with a permanent or temporary address in the Republic of Slovenia or a business entity established in the Republic of Slovenia.
- Hold a medical degree, pharmacy degree, or a veterinary degree (or a
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References
The Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP) can require a local PV contact person in Slovenia for individual cases. The MAHs may nominate the local PV contact person in Slovenia voluntarily, as well as the PV contact person has to be named also as per JAZMP’s request after the JAZMP issues a decision.
Regulatory Affairs
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Local RA Person Requirements
Local RA role not mandatory but useful for communication.
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Other mandatory local roles?
No additional mandatory roles are required in Slovenia.
Authorities
National Competent Authorities in Slovenia
Contact
Contact us for more information
Contact type
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