Overview
Pharmacovigilance and Regulatory Affairs services in Estonia
In Estonia, Insuvia works with pharmaceutical and biotech companies to provide PV and RA services that meet EU and Estonian regulatory requirements. We adapt our support to your business needs and market goals.
We deliver consulting on local regulatory requirements, assign a local contact person for PV, and carry out literature monitoring for compliance. Our services also include national procedure management and ongoing regulatory affairs support in Estonia.
Services in Estonia
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 Estonia
Pharmacovigilance
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Is an LPPV Required in Estonia?
Yes, the Local Person for Pharmacovigilance is required in EE.
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LPPV Requirements
The local PV person in Estonia must be fluent in Estonian.
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References
According to the Regulation of the Minister of Social Affairs no. 26 (§ 4 section 4), Estonian speaking contact person is required when there is a need for either direct healthcare professional communication (DHPC) and materials associated with additional risk (Educational Materials) in Estonia. This person should have overview of the additional risk minimisation measures implemented for the medicinal product (including the content of the topic, the target group of the recipients, training of the recipients), should ensure the dissemination of the materials to the recipients, and have overview of the method of dissemination, content of the topic, the target group of the recipients
and ensures the dissemination of the DHPC to the recipients, also must be able to answer requests of HCPs and regulatory authority.
Regulatory Affairs
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Local RA Person Requirements in Estonia
RA role is not mandatory in Estonia.
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Other mandatory local roles?
There are no other mandatory roles in Estonia.
Authorities
National Competent Authorities in Estonia
Contact
Contact us for more information
Contact type
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