PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for the Cypriot Pharmaceutical Market: Ministry of Health | EMA | ICH
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for Marketing Authorization Holders (MAHs) in Cyprus.
As Cyprus prepares for its 2026 EU Presidency, the national focus has shifted toward aggressive pharmaceutical reform, antibiotic resistance monitoring, and digital modernization. In 2025, the Pharmaceutical Services (Ministry of Health) has introduced stricter criteria for local representation and fully integrated with the EMA IRIS platform for post-authorization procedures. Our services ensure that MAHs—whether local manufacturers or international importers—remain fully compliant with both national mandates and European-wide scientific standards.
Who We Support in Cyprus
We provide specialized pharmacovigilance expertise across the Cypriot life sciences landscape:
Local Pharmaceutical Manufacturers: Supporting Cyprus’s robust manufacturing sector in Nicosia and Limassol with global aggregate safety reporting for exported portfolios.
International Importers & Distributors: Ensuring that innovative medicines and generics imported into Cyprus meet the Article 126a (Exceptional Authorization) safety requirements.
Local Pharmacovigilance Responsible (LPPV): Providing technical bandwidth to meet the 2025 updated criteria for LPPVs, including residency in Cyprus and proficiency in the Greek language.
Parallel Importers: Managing safety monitoring and reporting for products sourced across the EEA, ensuring alignment with the national Pharmacy and Poisons Law.
Clinical Trial Sponsors: Drafting Development Safety Update Reports (DSURs) for trials managed under the oversight of the Cyprus National Bioethics Committee.
Our PSUR & PBRER Services
Our scientific precision matches the rigor of the Pharmaceutical Services and the Drug Council:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully synchronized with the EMA IRIS digital submission workflows that became mandatory in February 2025.
LPPV Technical Support: Assisting local representatives with scientific signal detection and medical writing to fulfill their 24/7 availability and authority communication mandates.
Benefit-Risk Synthesis: High-level medical evaluations that justify the safety profile of medicines in the specific clinical context of the Cypriot healthcare system (GeSY).
Bilingual Labeling & Safety Updates: Ensuring all Risk Minimization Measures (RMMs) and safety summaries are compliant with the mandatory Greek and English requirements.
Supply Chain & Shortage Reporting: Aligning safety dossiers with the new 2025 digital platform for medicine pricing and supply monitoring.
Why Pharma Leaders in Cyprus Choose PSUR Central
"Scientific rigor for Europe's key Mediterranean pharmaceutical gateway."
2025 Regulatory Specialists: Fully operational on the IRIS platform and versed in the October 2025 EMA updates regarding Cypriot LPPV residency and language criteria.
Small Market Expertise: We understand the challenges smaller member states face regarding innovative medicine access and provide the scientific documentation to support Art. 126a approvals.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across the EMA, Cypriot Pharmaceutical Services, and the US FDA.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Pharmacy and Poisons Law (Cap. 254): The legal foundation for pharmaceutical regulation in Cyprus.
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
Decree (K.D.P.) 2025 Updates: Regarding national pharmacovigilance contact persons.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
Get Started: Partner With Us
To initiate a customized project for your Cypriot-based operations, we typically require:
Product Portfolio and authorization type (National, MRP, DCP, or Art. 126a).
Approved Labeling: The Cypriot SmPC (ΠΧΠ) in Greek and English.
Estimated Patient Exposure: Units sold or patient-years (Global and Cyprus-specific).
Summary of ICSRs: Line listings and tabulations from EudraVigilance or your global safety database.
Submission Calendar: Coordination with EURD list deadlines or specific national renewal cycles.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.