Your Trusted Partner for Pharmacovigilance Support in Greece
Greece represents a strategically important pharmaceutical market within the European Union, offering access to a well-regulated healthcare system and alignment with EU pharmacovigilance frameworks. However, successful market entry and lifecycle compliance require more than approvals; they demand robust pharmacovigilance systems, local regulatory coordination, and strict adherence to EU Good Pharmacovigilance Practices (GVP).
Operating in Greece requires companies to integrate EU-level pharmacovigilance standards with country-specific requirements, including local language communication and regulatory engagement.
At DDReg, we provide end-to-end pharmacovigilance services in Greece, ensuring compliance, patient safety, and seamless integration with EU pharmacovigilance systems.
Pharmacovigilance Framework in Greece
Pharmacovigilance in Greece is regulated by the National Organization for Medicines (EOF – Εθνικός Οργανισμός Φαρμάκων) under the Ministry of Health.
The EOF is responsible for:
- Monitoring adverse drug reactions (ADRs)
- Overseeing post-marketing safety
- Enforcing compliance with EU and national pharmacovigilance regulations
- Ensuring public health protection through risk management
As an EU member state, Greece follows harmonized pharmacovigilance systems integrated with European Medicines Agency (EMA) frameworks.
Normative Framework Governing Pharmacovigilance in Greece
Pharmacovigilance obligations in Greece are governed by a combination of EU legislation and national regulatory guidance:
- Directive 2001/83/EC – Governs medicinal products for human use across the EU
- Regulation (EC) No 726/2004 – Defines centralized authorization and pharmacovigilance systems
- EU Good Pharmacovigilance Practices (GVP) – Core operational framework for PV activities
- Greek Medicines Legislation – National implementation of EU directives
- EOF Guidelines & Circulars – Provide country-specific reporting requirements, formats, and timelines
This framework requires strict compliance with EU systems alongside local regulatory expectations.
QPPV and Local Pharmacovigilance Requirements in Greece
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Qualified Person for Pharmacovigilance (QPPV)
- Mandatory for all Marketing Authorization Holders (MAHs)
- Must reside within the EU/EEA
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Responsible for:
- Maintaining the pharmacovigilance system
- Monitoring product safety
- Acting as a 24/7 contact for regulatory authorities
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Local Pharmacovigilance Contact in Greece
- Typically required
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Facilitates:
- Communication with EOF in Greek
- Local adverse event reporting coordination
- Regulatory submissions and follow-ups
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Pharmacovigilance System Master File (PSMF)
- Mandatory for all MAHs
- Must describe the pharmacovigilance system
- Must be available for inspection and aligned with EU GVP requirements
Our Pharmacovigilance Services in Greece
DDReg provides comprehensive drug safety services in Greece, ensuring full compliance with EU GVP and EOF-specific requirements.
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Individual Case Safety Report (ICSR) Management
- End-to-end case processing and validation
- MedDRA coding and medical review
- EudraVigilance-compliant submissions
- Timely reporting aligned with EU timelines
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Responsibilities of the Local PV Contact
- Adverse event (AE) reporting to the FDA
- Implementation of risk management measures
- Maintenance of pharmacovigilance compliance
- Acting as the primary liaison with the FDA
This makes local presence critical for regulatory approval and ongoing compliance.
Our Pharmacovigilance Services in Greece
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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 Support & Local PV Compliance
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Literature Screening & Safety Intelligence
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Pharmacovigilance Consulting Services in Greece
Why Choose DDReg as Your Pharmacovigilance Company in Greece?
Support across clinical and post-marketing stag
Designed for EMA and national authority audits.
Aligning EU QPPV systems with local compliance requirements.
Advanced tools for accurate and efficient safety data management.
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