Overview
Pharmacovigilance and Regulatory Affairs services in Czechia
In the Czech Republic, Insuvia delivers Pharmacovigilance and Regulatory Affairs services that align with EU directives and Czech regulations. Our team ensures smooth compliance throughout your product’s lifecycle.
We offer tracking of local regulatory developments, provision of a local Qualified Person for Pharmacovigilance, and local scientific literature searches. Our team also manages national regulatory filings and delivers ongoing RA operational support in the Czech Republic.
Services in Czechia
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 Czechia
Pharmacovigilance
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Is an LPPV Required in Czechia?
Yes, the Local Person for Pharmacovigilance is required in CZ.
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LPPV Requirements
- Must be able to communicate in Czech or Slovak language.
- Must be contactable on the phone number with the Czech country calling code.
- Must reside in the EU.
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References
The Medicinal Products Act (Official Gazette No. 76/13 and 90/14; Article 3, Item
58) and Ordinance on Pharmacovigilance (Official Gazette 83/13), set a legal
obligation for the MAH to appoint a contact person for PV in Croatia. In addition
to the primary local PV person, a Deputy with equal qualifications is required.
Regulatory Affairs
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Local RA Person Requirements in Czechia
RA role is not mandatory in Czechia.
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Other mandatory local roles?
Pricing/Reimbursement – may be managed by a person seated in EU. PoA for such person is needed. It may be outsourced person.
Authorities
National Competent Authorities in Czechia
Contact
Contact us for more information
Contact type
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