Overview
Pharmacovigilance and Regulatory Affairs services in Portugal
Insuvia partners with pharmaceutical and biotech companies in Portugal to provide Pharmacovigilance and Regulatory Affairs services that comply with EU and Portuguese regulations. We guide you through compliance challenges effectively.
We ensure advisory on national PV/RA obligations, appoint a local contact person for PV, and perform a local literature review. Our team also manages regulatory submissions and maintains continuous regulatory affairs support in Portugal.
Services in Portugal
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 Portugal
Pharmacovigilance
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Is an LPPV Required in Portugal?
Yes, Local Person for Pharmacovigilance is required in PT.
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LPPV Requirements
The local PV person in Portugal must:
- Be located in Portugal;
- Be fluent in Portuguese;
- Perform their PV functions permanently and continuously;
- Have appropriate training and experience in PV;
- Possess suitable training and experience in pharmacovigilance;
- Have knowledge of the pharmacovigilance system in place;
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References
The Portuguese National Legislation a national law (Decreto-Lei n.º 20/2013 of 14 February, amending Decreto-Lei n.º 176/2006 of 30 August) requires to appoint a contact person for pharmacovigilance issues at a national level in Portugal, who reports to the qualified person for pharmacovigilance.
Regulatory Affairs
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Local RA Person Requirements
Local Regulatory Affairs role is not mandatory in Portugal.
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Other mandatory local roles?
The MAH can have a local representative to manage its obligations and communications with the authorities and pricing and reimbursement (usually is a legal entity, a company) but it is not mandatory.
Authorities
National Competent Authorities in Portugal
Contact
Contact us for more information
Contact type
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