Overview
Pharmacovigilance and Regulatory Affairs services in Latvia
In Latvia, Insuvia supports pharmaceutical and biotech companies with Pharmacovigilance and Regulatory Affairs services tailored to EU and Latvian requirements. We ensure your products remain compliant from launch through post-market stages.
We offer local regulatory intelligence on pharmacovigilance and regulatory affairs requirements, appoint a local pharmacovigilance responsible, and carry out local scientific literature searches. Our experts also manage regulatory filings at the national level and provide RA operational support in Latvia.
Services in Latvia
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 Latvia
Pharmacovigilance
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Is an LPPV Required in Latvia?
Yes, the Local Person for Pharmacovigilance is required in LV.
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LPPV Requirements
The local PV person in Latvia must:
- Reside and operate in Latvia;
- Must be available 24/7.
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References
- Regulation No 47 „Procedure for Pharmacovigilance” requires MAH to nominate a contact person for PV issues at a national level in Latvia if the EUQPPV does not reside and work in Latvia. The local contact person for PV in Latvia must report to the QPPV and act following the instructions of the QPPV (reporting in this context relates to pharmacovigilance tasks and responsibilities and not necessarily to line management).
- MAHs shall immediately submit the contact details of the national level contact person – given name, surname, address of site of operation, electronic mail address, phone number and fax number (if such exists), also for communication outside of working hours, as well as changes in the contact details (if any) to the State Agency of Medicines. The requirement to submit contact details for outside of working hours proves that local PV person must be available 24/7.
Regulatory Affairs
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Local RA Person Requirements in Latvia
Local Regulatory Affairs person is required in Latvia.
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Other mandatory local roles?
No additional mandatory roles in Latvia.
Authorities
National Competent Authorities in Latvia
Contact
Contact us for more information
Contact type
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