With application of the new European Veterinary Medicinal Products Regulation (EU) 2019/6, herd-specific/autologous vaccines are considered veterinary medicinal products subject to the provisions of that Regulation regarding manufacturing, veterinary prescription, record-keeping obligations of owners and keepers of food-producing animals, appropriate disposal, advertising restrictions, farm controls and the prohibition of supply in the event that they pose a risk to public health, animal health or environment (Art. 94, 105, 108, 117, 120, 123 and 134 of Regulation (EU) 2019/6). The conditions for use are regulated in Art 106(5) of Regulation (EU) 2019/6, according to which use is only possible if no authorised or approved immunological veterinary medicinal product is available for this target animal species and this indication and this specific inactivated vaccine has been prescribed by a veterinarian.
With the entry into force of the Austrian Veterinary Medicinal Products Act (TAMG, Federal Law Gazette I No. 186/2023), which is based on the Regulation (EU) 2019/6, these inactivated vaccines, which are not subject to an industrial manufacturing process,  pursuant to Section 7(2) may only be placed on the Austrian market if they are notified to the Federal Office for Safety in Health Care (BASG) no later than three months after they have been placed on the market. The first notification should be made by 30.09.2024 and include at least the data for the 3rd quarter of 2024.

To notify the herd-specific/autologous vaccines placed on the market in Austria in the corresponding quarter, please fill in the fields provided in the Excel-form available under the following Formular: BASG - TForms. The completed Excel-form should be named with the corresponding year and quarter (e.g. III-2024). Further information on the reporting process can also be found in the Guidance to Notification of Herd-Specific/Autologous Vaccines.

Pursuant to Austrian Bestandsspezifische Impfstoffe – Betriebsordnung (BIBO, Federal Law Gazette II No. 248/2010), each company/manufacturer must maintain a system to systematically record complaints, evaluate them and take effective systematic precautions to ensure that herd-specific/autologous vaccines placed on the market can be recalled quickly at any time. Any defect that may lead to a recall or restriction of sales must be reported immediately by the company/manufacturer to the Federal Office for Safety in Health Care (BASG) by e-mail to am-qualitaetsmangel@basg.gv.at and basg-v-phv@basg.gv.at.