Cyprus is a dynamic EU Member State in the Eastern Mediterranean, offering access to the European single market and growing opportunities for pharmaceutical and medical device manufacturers.
The Pharmaceutical Services of the Ministry of Health (Υπουργείο Υγείας – Φαρμακευτικές Υπηρεσίες) is the national competent authority in Cyprus responsible for regulating medicines, medical devices, clinical trials, pharmacovigilance, and vigilance. As an EU Member State, Cyprus fully implements centralized procedures via EMA for medicines and MDR/IVDR for medical devices, with Pharmaceutical Services managing national procedures, decentralized/mutual recognition procedures, Greek language requirements, and local compliance oversight. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate Cyprus’s EU-harmonized framework efficiently, prepare compliant submissions (including Greek labelling), secure timely approvals, and ensure long-term compliance in this strategic EU market.
Get Cyprus Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Cyprus-specific adaptation, scientific/technical review, and quality assurance for Pharmaceutical Services/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via Pharmaceutical Services and EMA, including validation, follow-up, and query handling.
Preparation and submission of CTAs/CTIS applications to Pharmaceutical Services, ethics committee coordination, and regulatory support for clinical trials in Cyprus.
Cypriot QPPV/local contact person services, PSUR/PBRER submissions to Pharmaceutical Services/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body liaison, conformity assessment, vigilance reporting, and Pharmaceutical Services registration/oversight compliance in Cyprus.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per Pharmaceutical Services and EU requirements.
Greek labelling review, Blue Box/EEA requirements, mock-ups, readability testing, and Pharmaceutical Services approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with Pharmaceutical Services and EMA/EEA standards.
Strategic consulting, optimal pathway selection (centralized/national/DCP/MRP), Pharmaceutical Services scientific advice preparation, and up-to-date Cypriot/EU regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Cyprus — from Pharmaceutical Services/EMA submissions and MDR/IVDR compliance to pharmacovigilance, Greek labelling, and sustained EU market success.
Contact Our Cyprus Regulatory Experts