Pharmacovigilance & Drug Safety Services Provider in Bulgaria
Bulgaria is a strategically important pharmaceutical market within the European Union, offering access to the broader EU region while maintaining its own regulatory oversight. Operating in Bulgaria requires strict adherence to EU pharmacovigilance legislation, national regulatory frameworks, and continuous safety monitoring obligations.
For pharmaceutical companies, success in Bulgaria depends on establishing robust pharmacovigilance systems aligned with EU Good Pharmacovigilance Practices (GVP), supported by qualified personnel and inspection-ready processes.
At DDReg, we deliver end-to-end pharmacovigilance services in Bulgaria, ensuring compliance, operational efficiency, and patient safety across the product lifecycle.
Pharmacovigilance Framework in Bulgaria
Pharmacovigilance in Bulgaria is regulated by the Bulgarian Drug Agency under the Ministry of Health.
As an EU Member State, Bulgaria operates within a harmonized European pharmacovigilance system, requiring alignment with:
- European Medicines Agency (EMA) requirements
- EU Good Pharmacovigilance Practices (GVP)
- EudraVigilance reporting systems
The BDA ensures that Marketing Authorization Holders (MAHs) maintain high standards of safety monitoring, reporting, and compliance.
Normative Framework Governing Pharmacovigilance in Bulgaria
Pharmacovigilance obligations in Bulgaria are defined through national legislation aligned with EU directives:
- Medicinal Products in Human Medicine Act – Core legal framework governing medicinal products and pharmacovigilance
- Regulation No 15/2009 – Defines requirements for manufacturing and import authorizations and Good Manufacturing Practice (GMP)
- Regulation No 27/2007 – Specifies requirements for marketing authorization dossiers and documentation
- Guidelines on Good Distribution Practice (GDP) – Ensure quality and integrity of medicinal products across the supply chain
These frameworks operate alongside EU legislation, requiring full regulatory alignment and lifecycle compliance.
QPPV and Local Pharmacovigilance Requirements in Bulgaria
As part of the EU pharmacovigilance system, Bulgaria follows strict personnel and system requirements:
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Qualified Person for Pharmacovigilance (QPPV)
- Mandatory for all MAHs
- Must reside within the EU/EEA
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Responsible for:
- Establishing and maintaining the pharmacovigilance system
- Monitoring product safety profiles
- Acting as the primary contact for regulatory authorities
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Local Qualified/Contact Person (LQPPV / LCPPV)
- May be required depending on organizational structure
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Supports:
- Local regulatory communication with the BDA
- Adverse event reporting coordination
- Language-specific and operational requirements
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Pharmacovigilance System Requirements
- Maintenance of a Pharmacovigilance System Master File (PSMF)
- Compliance with EU GVP modules
- Continuous safety monitoring and reporting
This makes EU-aligned pharmacovigilance systems essential for compliance in Bulgaria.
Our Pharmacovigilance Services in Bulgaria
DDReg provides comprehensive drug safety services in Bulgaria, ensuring compliance with both EU and national regulatory requirements.
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Individual Case Safety Report (ICSR) Management
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Aggregate Reporting & Safety Writing
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Signal Detection & Risk Management
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QPPV & Pharmacovigilance System Support
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Literature Screening & Safety Intelligence
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Pharmacovigilance Consulting Services in Bulgaria
Why Choose DDReg as Your Pharmacovigilance Company in Bulgaria?
Deep understanding of EMA, GVP, and BDA regulatory expectations.
Comprehensive support across clinical and post-marketing phases.
Designed for EU audits and regulatory inspections.
Providing qualified QPPV oversight with continuous availability.
Advanced safety systems ensuring accuracy, compliance, and scalability.
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