The Federal Office for Safety in Health Care (BASG), supported operationally by AGES, is Austria's national authority for medicines safety and pharmacovigilance.
Core official resources
- BASG pharmacovigilance for companies — national industry pharmacovigilance resources.
- Human adverse reaction notification — national reporting routes and legal context.
- Pharmacovigilance FAQ — national clarifications for MAHs and other stakeholders.
- PHV wordings — Austrian implementation resource for safety-related product-information changes arising from PSUR outcomes, PRAC signals, referrals and related procedures.
Practical use
BASG states that healthcare professionals have statutory reporting duties under Austrian medicines legislation, while MAHs submit suspected adverse reactions electronically to EudraVigilance. The BASG FAQ and PHV-wording database are therefore useful national implementation resources alongside EU legislation and GVP.