Overview
Pharmacovigilance and Regulatory Affairs services in Ireland
Insuvia supports pharmaceutical and biotech companies in Ireland with PV and RA services that comply with EU legislation and Irish requirements. We help you achieve smooth regulatory outcomes.
We provide intelligence on local regulatory requirements, assign a local person responsible for PV, and conduct local scientific literature searches. In Ireland, we also coordinate national regulatory procedures and ensure RA license maintenance.
Services in Ireland
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 Ireland
Pharmacovigilance
-
Is an LPPV Required in Ireland?
No, the Local Person for Pharmacovigilance is not required in IE.
-
References
There is no legal requirement to appoint a local PV contact person in Ireland, the EU-QPPV residing within the EEA is sufficient.
Regulatory Affairs
-
Local RA Person Requirements in Ireland
There are no specific requirements for Local RA Person in Iceland.
-
Other mandatory local roles?
No additional mandatory roles in Ireland.
Authorities
National Competent Authorities in Ireland
Contact
Contact us for more information
Contact type
Thank you for submitting. We will get in touch with You as soon as possible.
Thank you for submitting. We will get in touch with You as soon as possible.