Overview
Pharmacovigilance and Regulatory Affairs services in Malta
Insuvia assists pharmaceutical and biotechnology companies in Malta with Pharmacovigilance and Regulatory services tailored to EU and Maltese regulations. We ensure your products meet all compliance requirements.
We provide consulting on local regulatory requirements, appoint a local pharmacovigilance responsible, and conduct literature monitoring for compliance. Additionally, we manage regulatory submissions and maintain national RA services in Malta.
Services in Malta
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 Malta
Pharmacovigilance
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Is an LPPV Required in Malta?
No, Local Person for Pharmacovigilance is not required in MT.
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References
There is no legal requirement to appoint a local PV contact person in Malta, the EU-QPPV residing within the EEA is sufficient.
Regulatory Affairs
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Local RA Person Requirements
There are no specific requirements for local Regulatory Affairs Person.
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Other mandatory local roles?
There are no additional mandatory roles in Malta.
Authorities
National Competent Authorities in Malta
Contact
Contact us for more information
Contact type
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