National Legislation / Information

Veterinary Medicinal Products Act (TAMG)
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 national level (
The Austrian Veterinary Medicinal Products Act includes both the provisions for authorisation (former Austrian Medicinal Products Act AMG) and those for control (former Austrian Veterinary Medicinal Products Control Act TAKG).


Prescription status
In the new QRD template (v9), the prescription status is only required in the SmPC (10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS) and the product information leaflet (13.), but no longer in the labelling.
However, if the applicant sees the inclusion of the prescription status as expedient, the application for inclusion can be made nationally in accordance with Article 13 of the Veterinary Medicinal Products Regulation (EU) 2019/6.
Appropriate justification must be attached to the application.

Further information on the can be found at:


The updated fee schedule has been published here:
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.

BASG offered a BASG talk (BASG-Gespräch) on the New Veterinary Medicines Regulation on 8 Nov. 2022, and the programme and slides have been filed here:




Further inquiry note