National Requirements
In Austria, National Requirements also apply in addition to the European Requirements.
Veterinary Medicinal Products Act (TAMG) and Veterinary Medicinal Products Adjustment Regulation 2024
The Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection brought the national Veterinary Medicinal Products Act into force on 30 Dec 2023, which defines the implementation of the Veterinary Medicinal Products Regulation (EU) 2019/6 and supplementary provisions at the national level (RIS - BGBLA_2023_I_186 - Bundesgesetzblatt authentisch ab 2004).
The Federal Ministry of Social Affairs, Health, Care, and Consumer Protection enacted the national Veterinary Medicinal Products Adjustment Regulation 2024 on 29 January, 2025. This regulation implements the Veterinary Medicinal Products Regulation (EU) 2019/6 and the Veterinary Medicinal Products Act (TAMG) at the national level (RIS - BGBLA_2025_II_10 - Bundesgesetzblatt authentisch ab 2004).
The most frequently asked questions for marketing authorisation holders are described here (FAQ TAMG and Adjustment Regulation).
BASG “All-in-One Register”
For information on the medical product system of the Federal Office for Safety in Health Care (BASG) please see the "BASG “All-in-One Register”.
eService
Since 1 July 2013, Austrian communication between companies and authorities regarding approval and amendment procedures for (veterinary) medicinal products has primarily been carried out via the e-service platform. Detailed information can be found at FAQ Online Services.
Batch release
For certain proprietary medicinal products, an Official Control Authority Batch Release (OCABR) must be obtained from the Austrian Official Medicinal Control Laboratory (OMCL) before they can be placed on the market.
For further information please see Batch release.
Fees
The updated fee schedule has been published here: Fees - BASG.
In addition to new fees for veterinary clinical trials, reduced fees have been introduced for marketing authorisation applications for limited markets and under exceptional circumstances in accordance with Articles 23 and 25 of Regulation (EU) 2019/6. The previous veterinary reductions remain in place.
