Overview
Pharmacovigilance and Regulatory Affairs services in France
Insuvia assists pharmaceutical and biotech companies in France with PV and RA services designed to ensure compliance with EU legislation and French national requirements. Our specialists combine knowledge of European frameworks with a deep understanding of the French regulatory environment.
We offer monitoring of the local regulatory landscape, act as the local pharmacovigilance representative, and conduct local scientific literature searches. Alongside this, we oversee DCP/MRP national phase implementation and provide ongoing local regulatory affairs support to meet French requirements.
Services in France
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 France
Pharmacovigilance
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Is an LPPV Required in France?
Yes, the Local Person for Pharmacovigilance is required in FR.
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LPPV Requirements
The local PV person in France must:
- Be a Medical Doctor (MD) or a Pharmacist;
- Live and operate in France;
- Have experience in pharmacovigilance
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References
- Article 5.5121-164 of the French Public Health Code (Code de la Santé
Publique), imposes an obligation to nominate a local PV responsible person in France; - This function is not dependent on a marketing authorization but is mandatory for every company that promotes and distributes human
medicinal products in France (independently if the company is MAH or not); - Upon his/her appointment, the persons identity, qualifications and contact details must be communicated to the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) (French: National Security
Agency of Medicines and Health Products) for human medicinal products.
- Article 5.5121-164 of the French Public Health Code (Code de la Santé
Regulatory Affairs
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Local RA Person Requirements in France
Local RA person not mandatory.
France has specific RA requirements that mean companies need on-the-ground regulatory affairs expertise. Hightly recommended to have Local French expertise and easly communication with ANSM concerning the following points:1-through the DCP or MRP, companies must then undergo the national phase and handle PI translation and submission to ANSM with specific template form and process.
2-for CP, there is the blue Box to be manage and liaise with ANSM in order to add this specific French information (national registration codes, so-called “CIP codes”, name of the Exploitant, local prescription and delivery conditions etc.)
3- Exploitant transfer is a purely French activity, managed by the MAH locally with ANSM.
4-Managing artworks and packaging with specific pictograms, delivery regimens, braille code.
5- very strict French rules for promotional materials.
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Other mandatory local roles?
There are no other mandatory roles in France.
Authorities
National Competent Authorities in France
Contact
Contact us for more information
Contact type
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