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 (RIS - BGBLA_2023_I_186 - Bundesgesetzblatt authentisch ab 2004).

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).

Veterinary Medicinal Products Adjustment Regulation 2024

The Federal Ministry of Social Affairs, Health, Care, and Consumer Protection enacted the national Veterinary Medicinal Products Adjustment Regulation 2024 on January 29, 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). 

Renewal

According to Article 152 Paragraph 1 of Regulation (EU) 2019/6 as amended in conjunction with Section 93 Paragraph 2 of the Veterinary Medicines Act as amended (TAMG), veterinary medicinal specialties that were approved before January 28, 2022 on the basis of the provisions of the Medicinal Products Act (AMG) are considered to be unlimited authorised.

It is therefore neither necessary to submit an application for a renewal nor to have the marketing authorisation updated. 

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 Prescription of medicines - BASG. 

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. 

BASG talk

Schedule and slides (the majority in English) of our BASG talks can be found here: