Overview
Pharmacovigilance and Regulatory Affairs services in Croatia
Insuvia works with pharmaceutical and biotech companies in Croatia to provide PV and RA services that meet EU legislation and Croatian requirements. We combine local insight with European compliance standards.
We provide local PV/RA intelligence, assign a local person responsible for pharmacovigilance, and conduct local literature reviews. In Croatia, we also oversee DCP/MRP procedures and ensure local regulatory affairs maintenance.
Services in Croatia
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 Croatia
Pharmacovigilance
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Is an LPPV Required in Croatia?
Yes, the Local Person for Pharmacovigilance is required in HR.
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LPPV Requirements
The local PV person in Croatia must:
- Hold an education of:
- a Medical Doctor (MD) specialized in clinical pharmacology, or a Medical Doctor (MD), or a doctor of dental medicine*, or a pharmacist*, or a master of medical biochemistry*, or a doctor of veterinary medicine*, with:
- at least 2 years of experience in pharmacovigilance or two years of experience in his/her profession.
- documented training in (1) in PV terminology, (2) spontaneous and solicited reporting of adverse reactions (ADRs), and (3) methods of ADR reporting, evaluation of ADRs, preparation of Individual Case
Safety Reports (ICSRs), PSURs, RMPs, and DSURs.
*If the person responsible for PV is not a medical doctor (MD), access to a medical doctor (MD) must be available and appropriately documented.
- a Medical Doctor (MD) specialized in clinical pharmacology, or a Medical Doctor (MD), or a doctor of dental medicine*, or a pharmacist*, or a master of medical biochemistry*, or a doctor of veterinary medicine*, with:
- Reside in the Republic of Croatia.
- Be available 24/7.
- Must be registered at the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) for performing ADR monitoring activities or PV activities, or must be employed by a legal person registered at HALMED for performing ADR monitoring activities or PV activities
- Hold an education of:
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References
The Medicinal Products Act (Official Gazette No. 76/13 and 90/14; Article 3, Item 58) and Ordinance on Pharmacovigilance (Official Gazette 83/13), set a legal obligation for the MAH to appoint a contact person for PV in Croatia. In addition to the primary local PV person, a Deputy with equal qualifications is required.
Regulatory Affairs
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Local RA Person Requirements in Croatia
RA role is not mandatory in Croatia.
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Other mandatory local roles?
There are no other mandatory roles required.
Authorities
National Competent Authorities in Bulgaria
Contact
Contact us for more information
Contact type
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