Overview
Pharmacovigilance and Regulatory Affairs services in Luxembourg.
Insuvia provides expert Pharmacovigilance and Regulatory Affairs services in Luxembourg, helping pharmaceutical and biotech companies stay compliant with EU and local regulations.
We deliver tracking of local regulatory developments, assign a national PV responsible person, and carry out local literature surveillance for PV. Our team also manages marketing authorisations and ensures ongoing regulatory affairs operations in Luxembourg.
Services
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 Luxembourg
Pharmacovigilance
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Is an LPPV Required in Luxenbourg?
Yes, Local Person for Pharmacovigilance is required in LU.
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LPPV Location & Availability Rules
LPPV should reside and carry out their activities in the European Union;
LPPV should be reachable 24 hours a day, 7 days a week;
They should be at a minimum with documented experience in all aspects of pharmacovigilance in order to fulfill the responsibilities and tasks of the position;
Knowledge of languages allowing to communicate with national stakeholders is strongly recommended: French, German, English and/or Luxembourgish.
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References
Art. 45.3 of the Grand Ducal Regulation of September 10, 2012, on Pharmacovigilance, sets the requirement for Marketing Authorization Holders to nominate a reference person for PV at a national level in Luxembourg who should be linked to the EU QPPV.
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?
Note, that most Luxembourg activities (regulatory & prices) are in parallel with Belgium, the preferred reporter country for Luxembourg.
Authorities
National Competent Authorities in Luxembourg
Contact
Contact us for more information
Contact type
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