Overview
Pharmacovigilance and Regulatory Affairs services in Cyprus
In Cyprus, Insuvia offers Pharmacovigilance and Regulatory Affairs services that comply with EU legislation and national requirements. We adapt our solutions to your product needs and market objectives.
We ensure analysis of national PV/RA requirements, provision of a local PV contact, and local literature surveillance for compliance. Our experts also handle local submissions and provide ongoing RA operational support in Cyprus.
Services in Cyprus
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 Cyprus
Pharmacovigilance
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Is an LPPV Required in Cyprus?
Yes, the Local Person for Pharmacovigilance is required in CY.
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LPPV Requirements
- Must reside in Cyprus;
- Must be a qualified healthcare professional or a biologist or chemist;
- Must be adequately trained in pharmacovigilance;
- Must be fluent in written and spoken Greek.
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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 Cyprus
RA role is not mandatory in Croatia.
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Other mandatory local roles?
Local representative is mandatory for MAHs that do
not have a CY office/address or an appointed person on behalf of the MAH locally.
Authorities
National Competent Authorities in Cyprus
Contact
Contact us for more information
Contact type
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