Overview
Pharmacovigilance and Regulatory Affairs services in Spain
In Spain, Insuvia delivers Pharmacovigilance and Regulatory Affairs services designed to meet EU legislation and Spanish regulations. We ensure your products remain compliant and market-ready.
We provide guidance on local regulatory requirements, assign a local pharmacovigilance representative, and conduct local literature surveillance. In Spain, we also handle local variations and renewals and ensure national RA compliance.
Services in Spain
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 Spain
Pharmacovigilance
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Is an LPPV Required in Spain?
Yes, Local Person for Pharmacovigilance is required in ES.
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LPPV Requirements
The local PV person in Spain must:
- Be based in Spain;
- Must be available 24/7;
- Have the appropriate experience and training to perform his/her duties.
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References
Article 14, section 1, of the Royal Decree 577/2013 only for human products of Spain sets a legal obligation for MAHs to appoint and to permanently and continuously have a contact person for PV on a national level in Spain.
Regulatory Affairs
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Local RA Person Requirements
Local RA role not mandatory in Spain.
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Other mandatory local roles?
No additional mandatory roles are required in Spain.
Authorities
National Competent Authorities in Spain
Contact
Contact us for more information
Contact type
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