Your Partner for Pharmacovigilance Services in Austria
DDReg provides pharmacovigilance services in Austria for pharmaceutical marketing authorisation holders (MAHs). Our team operates local PV functions for foreign MAHs, manages BASG adverse event reporting, coordinates PSUR submissions via the EMA PSUR Repository, and delivers pharmacovigilance outsourcing Austria mandates across nationally and centrally authorised products.
Austria's Pharmacovigilance Framework
The Federal Office for Safety in Health Care (BASG) is Austria's national competent authority for pharmacovigilance, with technical functions operationally executed by AGES MEA (Austrian Medicines and Medical Devices Agency). Austria implements the EU pharmacovigilance framework under the Austrian Medicines Act (AMG). BASG implements PRAC safety measures for Austria-authorised medicines and contributes assessors to EMA pharmacovigilance committees.
An LCPPV (Local Contact Person for Pharmacovigilance) is not legally mandatory in Austria. BASG recommends that MAHs appoint a local contact and notify BASG by email or letter. Under the Austrian Medicines Act, BASG may require a locally based pharmacovigilance responsible person from any MAH at its discretion. Parallel import licence holders carry the same PV obligations as standard MAHs - PSMF, EudraVigilance reporting, and PSUR Repository submissions are all required.
Pharmacovigilance Outsourcing Austria - DDReg Services
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Local PV Function and Case Management
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PSUR Submissions and Signal Management
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Drug Safety Services Austria - Inspection Readiness
Austria Pharmacovigilance Reporting Timelines
| Obligation | Deadline | Route |
|---|---|---|
| Serious unexpected SADR (EEA) - all | 15 calendar days | EudraVigilance electronic submission |
| Non-serious ICSRs (EEA) | Within 90 days | EudraVigilance electronic submission |
| PSUR - EURD-listed substance | Per EURD list DLP | EMA PSUR Repository only |
| PSUR - non-EURD national submission | Per MA documentation frequency | EMA PSUR Repository ('non-EU single assessment') |
| QPPV / PSMF location change | Immediately | Article 57 database; BASG email notification recommended |
Pharmacovigilance Company in Austria - DDReg's Expertise
DDReg manages the BASG/AGES MEA dual-structure - BASG as sovereign authority, AGES MEA as technical executor. Our team handles German-language BASG correspondence, PSUR Repository submissions using correct Austrian national designations, and Article 57 database updates that replaced variation submissions in February 2016. This operational precision prevents compliance gaps that arise from treating Austria as a standard EU market without its specific procedural requirements.
BASG explicitly treats CESP and CD-ROM PSUR submissions as not submitted, only PSUR Repository uploads are valid. DDReg manages all PSUR submissions through the repository, monitors the EURD list monthly, and uses BASG form F_B23 for frequency change requests for non-EURD substances. Our PSUR submissions are confirmed before each DLP deadline.
BASG selects inspection candidates based on Austrian PV volume, PSUR statistics, and service provider activity. DDReg structures client PV systems to be audit-ready from the outset, not in response to inspection notification. When BASG inspects, DDReg coordinates the initial report response, CAPA plan submission, and final report resolution within the prescribed four-week windows.
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