Overview
Pharmacovigilance and Regulatory Affairs services in the United Kingdom
In the United Kingdom, Insuvia provides Pharmacovigilance and Regulatory Affairs services aligned with UK regulations and European standards. We support your compliance needs from launch to post-market stages.
We offer analysis of national PV/RA requirements, provision of a local person responsible for PV, and literature monitoring for local regulatory compliance. Our experts also manage national procedures and maintain continuous regulatory affairs support in the UK.
Services in the United Kingdom
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 The United Kingdom
Pharmacovigilance
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Is an LPPV Required in UK?
Yes, the Local Person for Pharmacovigilance is required in GB.
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LPPV Requirements
Local PV person must reside and operate in UK.
Additionally Local PV person must:
- Have access to the reports of suspected ADR and to PSMF for UK authorized products.
- Be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.
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References
If QPPV resides and operates in EU/EEA, MAHs must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV. Once the national contact person for pharmacovigilance has been appointed, their details should be notified to the MHRA via the MHRA Submissions Portal.
Regulatory Affairs
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Local RA Person Requirements in UK
Local Regulatory Affairs role is not mandatory in UK. However in practice, it is advisory to have a local expert.
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Other mandatory local roles?
There are no other mandatory roles required.
Authorities
National Competent Authorities in the United Kingdom
Contact
Contact us for more information
Contact type
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