Austria is a key Central European market within the EU, offering excellent opportunities for pharmaceutical and medical device manufacturers thanks to its advanced healthcare system, strong innovation ecosystem, and full access to the EU single market.
The Austrian Federal Office for Safety in Health Care (BASG – Bundesamt für Sicherheit im Gesundheitswesen), through its Austrian Medicines and Medical Devices Agency (AGES), is the national competent authority regulating medicines, medical devices, clinical trials, pharmacovigilance, and vigilance. Austria fully applies EU centralized procedures via EMA for medicines and MDR/IVDR for devices, with BASG/AGES handling national aspects, decentralized/mutual recognition procedures, national authorizations, and local compliance requirements. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate Austria’s EU-harmonized yet nationally administered framework, prepare compliant submissions, secure efficient approvals, and ensure long-term success in this high-value EU market.
Get Austria Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Austria-specific adaptation, scientific/technical review, and quality assurance for BASG/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via BASG and EMA, including validation, follow-up, and query handling.
Preparation and submission of CTAs/CTIS applications to BASG, ethics committee coordination, and regulatory support for clinical trials in Austria.
Austrian QPPV/local contact person services, PSUR/PBRER submissions to BASG/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body interactions, conformity assessment, vigilance reporting, and BASG registration/oversight compliance in Austria.
PMS/PMSR implementation, trend reporting, FSCA/FSCA notifications, vigilance compliance, and ongoing monitoring per BASG and EU requirements.
German labelling review (including Austrian specifics), Blue Box/EEA requirements, mock-ups, readability testing, and BASG approval support.
Full support for post-approval changes, renewals, line extensions, and lifecycle compliance with BASG and EMA/EEA standards.
Strategic consulting, optimal pathway selection (centralized/national/DCP/MRP), BASG scientific advice preparation, and up-to-date Austrian/EU regulatory intelligence.
Partner with Medwisdom for expert, streamlined, and fully compliant regulatory support in Austria — from BASG/EMA submissions and MDR/IVDR compliance to pharmacovigilance, lifecycle management, and sustained EU market success.
Contact Our Austria Regulatory Experts