Your Local Pharmacovigilance Partner for Drug Safety in Czech Republic
DDReg provides pharmacovigilance services in Czech Republic for pharmaceutical marketing authorisation holders. Our team operates as Local Person for Pharmacovigilance (LPPV) under SÚKL PHV-6 version 4 requirements effective 31 January 2025, coordinates QPPV notifications to SÚKL, manages Czech-language adverse event reporting, and delivers pharmacovigilance outsourcing Czech Republic mandates across nationally and centrally authorised products.
Czech Republic Pharmacovigilance Framework
The State Institute for Drug Control (SÚKL; Státní ústav pro kontrolu léčiv) is the Czech national competent authority for pharmacovigilance, headquartered in Prague. SÚKL implements the EU pharmacovigilance framework under Act No. 378/2007 Coll. on Pharmaceuticals. SÚKL guideline PHV-6 version 4, effective from 31 January 2025, establishes mandatory requirements for QPPV appointment, LPPV appointment, and PSMF change notification that all MAHs must follow.
All MAHs are obliged to appoint a QPPV and provide name, surname, and contact details to SÚKL within 7 calendar days, regardless of PSMF location. All MAHs are obliged to appoint an LPPV (Local Person for Pharmacovigilance) in Czech Republic and notify SÚKL within 7 calendar days, regardless of PSMF location. The LPPV must communicate in Czech or Slovak language, be contactable on a phone number with Czech country code, and reside in the EU. The minimum LPPV responsibility is to provide contact between SÚKL and the QPPV. The QPPV and LPPV may be the same person.
SUKL Pharmacovigilance Services - DDReg Offerings
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LPPV Function and SÚKL Coordination
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Drug Safety Services Czech Republic – Adverse Event Reporting
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PSURs and GVP Compliance
Czech Republic Pharmacovigilance Requirements - PHV-6 Version 4
| Obligation | Deadline | Authority |
|---|---|---|
| QPPV appointment notification | Within 7 calendar days | SÚKL Pharmacovigilance Department |
| LPPV appointment notification | Within 7 calendar days | SÚKL Pharmacovigilance Department |
| PSMF change notification (QPPV, location, MAH name, PV database, patient programme, audit findings) | Within 7 calendar days | SÚKL Pharmacovigilance Department |
| Suspected adverse incident reporting | Within 15 days of receiving information | SÚKL (online form, email, or phone) |
| PSUR | Per EURD list or registration requirements | EMA PSUR Repository; SÚKL notified |
| Critical/major audit findings | Within 7 days | SÚKL Pharmacovigilance Department |
Pharmacovigilance Company in Czech Republic - DDReg Expertise
SÚKL PHV-6 version 4 introduced mandatory LPPV appointment for all MAHs, 7-day notification deadlines for QPPV and LPPV appointments, and expanded PSMF change reporting obligations. DDReg provides named LPPV services notified to SÚKL within the required 7-day window, manages Czech country code phone contact, and coordinates all PSMF change notifications including QPPV changes, PV database changes, patient programme launches, and critical/major audit findings within the mandatory 7-day reporting period.
PHV-6 version 4 requires the LPPV to communicate in Czech or Slovak language. SÚKL Pharmacovigilance Department correspondence, adverse event reports, PSMF change notifications, and inspection coordination are conducted in Czech. DDReg provides Czech-language LPPV services, manages all SÚKL Czech-language communications, and coordinates with Czech-speaking medical personnel for adverse event causality assessment and narrative authoring.
PHV-6 version 4 mandates that the LPPV be contactable on a phone number with Czech country calling code. DDReg maintains a Czech country code contact number for SÚKL Pharmacovigilance Department communications, ensuring compliance with the contactability requirement and enabling SÚKL to reach the LPPV during Czech business hours for urgent safety queries or inspection coordination.
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