Overview
Pharmacovigilance and Regulatory Affairs services in Belgium
Insuvia assists pharmaceutical and biotech companies in Belgium with PV and RA services aligned with EU and Belgian regulations. Our experts offer practical and reliable compliance support.
We provide advisory on national PV/RA obligations, appoint a local pharmacovigilance representative, and perform local journals surveillance. Alongside this, we manage national procedures and ensure local RA coordination in Belgium.
Services in Belgium
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 Belgium
Pharmacovigilance
-
Is an LPPV Required in Belgium?
Yes, Local Person for Pharmacovigilance is required in BE. In practice, most companies nominate the local PV person in Austria voluntarily
-
Requirements for LPPV in Belgium
- Must be available 24 hours a day, 7 days a week;
- Must carry out activities in pharmacovigilance in Belgium;
- Must have adequate qualifications to carry out their activities in
pharmacovigilance, particularly the necessary language skills to talk to
partners in the national language of their choice and to communicate with the QPPV.
-
References
Article 66§2 of the Royal Decree 14/12/2066 of Belgium sets an obligation for the Marketing Authorization Holders (MAHs) to appoint a local PV contact person in Belgium and to notify his/her details to the Federal Agency for Medicines and Health Products of Belgium (FAMHP).
Regulatory Affairs
-
Local RA Person Requirements in Belgium
Local Regulatory Affairs role is mandatory. RIP (responsible person for information & publicity) has to verify the compliance of SPC, leaflets a their translations, and should sign of the Declaration of Conformity . The RIP person has to be notified at the authority FAHMP. RIP should be based on Belgium.
-
Other mandatory local roles?
There are no other mandatory roles required.
Authorities
National Competent Authorities in Belgium
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.