Overview
Pharmacovigilance and Regulatory Affairs services in Slovakia
Insuvia supports pharmaceutical and biotechnology companies in Slovakia with tailored Pharmacovigilance and Regulatory Affairs services designed to meet EU directives and Slovakia’s regulatory framework. We guide you through complex compliance requirements with precision.
Our services include tracking of local regulatory developments, assignment of a local PV contact, and literature monitoring for local regulatory compliance. We also support local variations and renewals while maintaining ongoing regulatory license support in Slovakia.
Services in Slovakia
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 Slovakia
Pharmacovigilance
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Is an LPPV Required in Slovakia?
Yes, Local Person for Pharmacovigilance is required in SK.
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LPPV Requirements
The local PV person in Slovakia must:
- Have a good knowledge and skills of pharmacovigilance issues;
- Have knowledge of relevant legislation and guidelines;
- Be able to communicate in Slovak or Czech language;
- The premises for this person can be out of Slovakia, but pharmacovigilance activities have to be applied in Slovakia.
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References
According to the national legislation of Slovakia (act 362/2012, §68, art.14), the State Institute for Drug Control requires MAHs to nominate a contact person responsible for PV issues at a national level in Slovakia.
Regulatory Affairs
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Local RA Person Requirements
MAH must authorize a local Regulatory Affairs person, with permanent residence in Slovakia for communication with NCA.
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Other mandatory local roles?
Pricing/Reimbursement: Local SK person seated in Slovakia is needed for communication with Ministry of Health. All submissions are only in Slovak language. At least two personal visits to Ministry of Health are needed for certification of such contact person.
Authorities
National Competent Authorities in Slovakia
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State Institute for Drug Contro
ŠÚKL -
Ministry of Health of the Slovak Republic
Website -
National Institute for Value and Technology in Health
NIKO -
Slovakian Medicines Verification System
SOOL -
National Centre for Healthcare Information and Statistics
NCZI -
E-categorization
Website -
System of Central Enlisting
ADC database
Contact
Contact us for more information
Contact type
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