Overview
Pharmacovigilance and Regulatory Affairs services in Greece
In Greece, Insuvia provides Pharmacovigilance and Regulatory Affairs services designed to meet EU and Greek legislation. We guide you through the national regulatory process with efficiency and precision.
Our offering includes pricing applications, reimbursement submissions, and support with early access programs. By combining compliance with market expertise, we help you secure access to the Greek market.
Services in Greece
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
- Local Literature Screening
- 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 Greece
Pharmacovigilance
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Is an LPPV Required in Greece?
Yes, the Local Person for Pharmacovigilance is required in GR.
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LPPV Requirements
- Must be fluent in Greek and English;
- Must have 2 years of experience in pharmacovigilance;
- Must have a degree in medicine, dentistry, biology, biochemistry, chemistry, veterinary medicine, or nursing highest (Higher Education);
- Must not belong to or be related to the marketing or promotion departments.
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References
Article 136 (4) of the Ministerial Decree no. Δ.ΥΓ3α/Γ.Π. 32221 ΦΕΚ 1049/29- 04- 2013 sets an obligation for the MAH to appoint a local qualified person for pharmacovigilance (local QPPV) in Greece.
Regulatory Affairs
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Local RA Person Requirements in Greece
Local RA person not mandatory in Greece.
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Other mandatory local roles?
Local representative is mandatory for MAHs that do not have a GR office/address or an appointed person on behalf of the MAH locally.
Authorities
National Competent Authorities in Greece
Contact
Contact us for more information
Contact type
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