In Austria, national requirements also apply in addition to the European requirements.

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 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.

For information on the medical product system of the Federal Office for Safety in Health Care (BASG) please see "BASG “All-in-One Register”.

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 Service Zulassung & Lifecycle ASP - BASG.

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 Chargenfreigabe - BASG.

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.

National requirements on the product information can be found here.

Name of the medicinal product

According to the Veterinary Medicinal Products Adjustment Regulation 2024, Article 2 §3, the name must include the target species or the addition “für Tiere”.

Prescription status

The prescription status is subject to national regulations. Detailed information can be found at Rezeptpflicht - BASG.

High-quality national translations

All submitted texts must provide a high-quality translation in accordance with the BEST PRACTICE GUIDE for the submission of high quality national translations for veterinary medicines (EMA/CMDv/5098/2022) or will otherwise be rejected by the BASG.

Electronic package leaflet

Please find detailed information here.

Implementation date

In principle, for VRAs, the date of approval by the BASG (“Approval Date”) is adopted as the date of the amendment to the dossier (“Implementation Date”).

However, an extension of the implementation date to 12 months over the course of the QRD adaptation is possible and can be initiated in two ways:

• in the Cover letter or
• in the eAF.

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 28 January, 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.

MAH transfer / Change of Ownership

Please find detailed information here.

Withdrawal of the marketing authorisation / registration

A veterinary withdrawal acc. to TAMG §15 is carried out in practice analogously to the human withdrawal acc. to AMG §23. Please find further information here.