Overview
Pharmacovigilance and Regulatory Affairs services in Italy
In Italy, Insuvia offers Pharmacovigilance and Regulatory Affairs services to help pharmaceutical and biotech companies meet EU and Italian regulations. We adapt our solutions to your business and product portfolio.
We offer monitoring of the local regulatory landscape, provision of a local pharmacovigilance representative, and national medical literature reviews. Our experts also handle local variations and renewals while maintaining regulatory compliance support in Italy.
Services in Italy
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 Italy
Pharmacovigilance
-
Is an LPPV Required in Italy?
No, the Local Person for Pharmacovigilance is not required in IT.
-
References
Italy does not specifically require the nomination of a local national contact person for pharmacovigilance (LNCPP), however, either the EU- QPPV or the LNCPP must register to the Italian national pharmacovigilance database (RNF) where all information is provided only in the Italian language. Therefore, if the EU-QPPV does not know the Italian language, it may be necessary to nominate a local contact person for pharmacovigilance for Italy.
Regulatory Affairs
-
Local RA Person Requirements in Italy
Local RA role is not mandatorily required by AIFA. However, AIFA Portal (for fees setup, variatons and renewals upload, P&R submissions) is in Italian. Interactions with mandatory databanks (Farmastampati, Bozen) and commercial databanks (farmadati, codifa) shall be in Italian.
-
Other mandatory local roles?
No additional mandatory roles in Italy.
Authorities
National Competent Authorities in Italy
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.