Since 2014, sales volumes of veterinary antibiotics by wholesalers and marketing authorization holders as well as the quantities dispensed by veterinarians from their veterinary in-house pharmacies (TÄHAPOs) to food-producing animals have been recorded and evaluated at national level in Austria on the basis of the Veterinary Antibiotics Volume Flow Regulation (Vet-AB-MengenströmeVO), Federal Law Gazette II No. 83/2014.

The new veterinary medicinal products legislation, Regulation (EU) 2019/6 in combination with the implementing acts published on the basis of Article 57 of Regulation (EU) 2021/578 and Regulation (EU) 2021/1248, has been in force in the European Union since 28.01.2022 and must be applied accordingly. The aim is to identify risk factors for animal health and public health in order to develop targeted measures to combat antimicrobial resistance. The basis for this is the identification of relevant trends in sales volumes and the use of antimicrobials in animals at national and Union level. Together with developments in the use of antimicrobial agents in humans and relevant data on antimicrobial-resistant organisms found in animals and humans, in food and in the environment, an integrated analysis is to be made possible. This should be used to derive appropriate measures in line with the European action plan to combat antimicrobial resistance in accordance with the “One Health” concept.

The Member States must develop or continue to develop suitable national data collection systems in order to achieve a complete collection of high-quality data on the use in the respective animal species concerned.
The EU-wide harmonized data collection/reporting obligation of antibiotic volume flows in the veterinary sector will therefore be gradually expanded on the basis of the existing Veterinary Antibiotics Volume Flow Regulation (EU: Regulation 2019/6, Regulation 2021/578). From 2024, the entire use of antibiotics in food-producing animals [= dispensing, direct use and prescription by the veterinarian] must be reported. From 2027, the use in horses and from 2030 also the use in non-food-producing animals (dogs, cats and fur animals (minks and foxes)) must be reported.

The reports on Vet-AB application are submitted on a voluntary basis. However, it is necessary that a uniform data format is used to record these messages. It is therefore necessary that this data format be specified in the Regulation.

You will find all veterinary medicinal products authorized in the EU on the following homepages.

https://medicines.health.europa.eu/veterinary/de

https://upd-portal-prod.azurewebsites.net/updwebui/home

The new EU Veterinary Medicinal Products Regulation defines “antimicrobial active substances”, i.e. antimicrobials - which make up the majority of anti-infectives - as any substance used to treat or prevent infections or infectious diseases with a direct and targeted effect on microorganisms such as bacteria, viruses, fungi and protozoa. This means that in addition to antibiotics, antivirals, antifungals and antiprotozoals are now also affected by data collection. The only exception is one group of anti-infectives, the antihelmintics, which are not directed against microscopic pathogens but are also classified as anti-infectives.

Within the meaning of the Veterinary Antibiotics Volume Flow Regulation (last amended by Federal Law Gazette II No. 127/2022), antibiotics are antimicrobial substances whose action is directed against bacteria and certain protozoa. They are marketed as veterinary medicinal products in the form of authorized proprietary medicinal products and are listed in the ATCvet (Anatomical Therapeutic Chemical) system of the WHO for the classification of active substances in veterinary medicinal products under the codes QA (digestive tract and metabolism), QD (dermatologicals), QG (urogenital tract), QJ (anti-infectives for systemic use) and QP51AG (antiprotozoals with antibacterial activity), as well as under QR (respiratory tract) and QS (sensory organs).

Active substances of antivirals, antifungals and antiprotozoals affected by data collection can be found under the codes QD, QJ, QP51, QR and QS (for details, see FAQs below).

The veterinary medicinal product/medicinal product dataset described in Section 3 of the Veterinary Antibiotics Volume Flow Regulation (Vet-AB-MengenströmeVO) contains information on all veterinary medicinal products with antimicrobial active substances, but also information on all other veterinary medicinal products authorized in Austria that are available to veterinarians for their work. In the near future, the dataset will be supplemented by certain antimicrobial human medicinal products whose ATC codes are listed in Regulation (EU) 2021/578, as veterinarians are also authorized to use human medicinal products in certain cases in the context of a therapeutic emergency. The dataset is kept up to date by AGES and is continuously supplemented and updated and can be downloaded at onlineService Veterinary Antibiotics Volume Flow Analysis.

Detailed, up-to-date information on the use of the respective veterinary medicinal product/medicinal product can be found in the Information for healthcare professionals and directions for use - the link is included in the dataset for the respective veterinary medicinal product/medicinal product.

Change expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!
The medicinal product dataset for livestock antibiotics contains the large master dataset (see Annex 1 of the Regulation BGBl II 83/2014, point 1.1.1), which also includes information on dosage or duration of use. In principle, the medicinal product dataset for antibiotics approved for pets or horses also consists of the data fields of the large master dataset, but those fields that are not mandatory fields according to the Vet-AB-MengenströmeVO are not filled in. Data that is required for the purpose of recording the consumption data of antimicrobial medicinal products for LM-supplying animals in accordance with the above-mentioned regulation, such as the dosage, is not listed here. This information can be found in the respective product information and instructions for use (see link in the XML download).

For all other authorized veterinary medicinal products (e.g. cardiovascular drugs, narcotics, analgesics, etc.), the medicinal product dataset contains the so-called small dataset (see Annex 1 of Regulation BGBl II 83/2014, point 1.1.2).
For all medicinal products for human use with an ATC code specified in Regulation (EU) 2021/578, a dataset containing the data required for reporting is also issued in the master data download.

Change to be expected on the basis of the amendment to the national Veterinary Antibiotics Volume Flow Regulation!
The following are obliged to report:

1. Companies that distribute veterinary medicinal products with antimicrobial active substances are obliged to submit an annual distribution report, whereby not only the distribution to veterinary in-house pharmacies (TÄ-HAPO), but also to all the bodies listed below must be reported:

veterinary in-house pharmacies

• public pharmacies
• Institutional pharmacy of the University of Veterinary Medicine Vienna
• Pharmacy(ies) of the Austrian Armed Forces
• other authorized entities for which the Federal Ministry of Health issues an ID number

2. Veterinarians running in-house pharmacies who dispensed veterinary medicinal products/medicinal products with antimicrobial active substances (currently only antibiotics pursuant to Section 2(1) VetABM-VO) from their TÄ-HAPO to animal owners for the treatment of food-producing animals pursuant to Section 7 Vet-AB-MengenströmeVO in the 2022 registration period. § Section 7 Vet-AB-MengenströmeVO are once again only obliged to submit a so-called dispensing notification [annual notification = dispensing of AB to the animal keeper] in 2023.

NEW from reporting year 2023: From 2024, veterinarians managing in-house pharmacies who dispense veterinary medicinal products/medicinal products with antimicrobial active substances (= all classes of antimicrobial medicinal products) from their TÄ-HAPO, use them directly on animals or prescribe them by prescription, are obliged to submit a dispensing notification [annual notification = dispensing of AB to the animal owner as before] and now a use notification [notification of prescriptions and use by the respective veterinarian himself/herself].

3. NEW since 2022: Veterinarians managing in-house pharmacies who have not dispensed any antimicrobial medicinal products from their TÄ-HAPO to the animal owner(s) of food-producing animals in accordance with Section 7 Vet-AB-MengenströmeVO have been obliged to submit a so-called empty dispensing report since 2022.

4. In addition, the voluntary detailed notification of use in accordance with Section 8 of the Veterinary Antibiotics Volume Flow Regulation remains possible.

The reports on Vet-AB application are submitted on a voluntary basis. However, it is necessary that a uniform data format is used to record these messages. It is therefore necessary that this data format be specified in the Regulation.

The reporting year (= the year following the reporting year) corresponds to the year in which the data is to be submitted electronically. The data recorded in the reporting year must be submitted electronically to the implementing body in the following year. Example: In the reporting year 2023, the data recorded in the reporting year 2022 will be transmitted to AGES-e-Service.

The reporting year corresponds to the reporting period for which you are submitting your report. Example: In the reporting year 2022, you report the data from the reporting year 2021. When you submit your annual report or empty report, you usually do so for the entire previous year. However, if you are planning to give up your TÄHAPO in the current year (retirement, relocation, etc.), you can also submit your declaration for the year that has already begun, in which case you should select 2022 as the reporting year or the corresponding year in which you want to submit the declaration.

Each veterinary medicine dispensary (TÄ-HAPO) is given an individual, unique number. This consists of the letters "HA", the five-digit location number (professional domicile of the veterinarian with federal state code) and the veterinarian number (also five digits).

e.g: HA1234567891

Change expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!

The following facilities must be included in the mandatory notification of companies:

• Veterinary in-house pharmacies
• public pharmacies
• Institutional pharmacy of the University of Veterinary Medicine Vienna
• Pharmacy(ies) of the Austrian Armed Forces
• other authorized entities for which the Federal Ministry of Health issues an ID number

Companies that distribute veterinary medicinal products with antimicrobial active substances to veterinary in-house pharmacies (TÄ-HAPO) and/or other pharmacies must keep records of these sales, which must be used to submit an annual report (= annual sales report) in accordance with Section 6 Vet-AB-MengenströmeVO.

The annual report (= annual distribution report) in accordance with the Vet-AB-MengenströmeVO must be submitted by March 31 of the following year for the relevant reporting year.

Change expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!

The ATCvet codes of veterinary medicinal products with antimicrobial active substances (= antibiotics) affected by the volume flow recording until the end of 2022 are published in the "Amtliche Veterinärnachrichten".

NEW: The ATCvet codes of veterinary medicinal products required in future (from 2023) for the distribution notification are published in Commission Regulation (EU) 2021/578. A distinction is made between ATCvet codes for antimicrobial veterinary medicinal products, which must be reported, and those with an ATCvet code, which can be reported on a voluntary basis.

The distribution notification includes all veterinary medicinal products that contain antimicrobial active substances and that are authorized for farm animals and/or pets in Austria or throughout the EU; also those veterinary medicinal products that are authorized exclusively for pets (see also FAQ).

You must report the opening of a TÄ-HAPO 14 days before the planned opening to the local district administrative authority responsible for your professional domicile, as before.

Apart from the announcement about the planned opening of the veterinary medicine chest you do not have to take any further step: Your notification will be forwarded by the district administrative authority to the Austrian Chamber of Veterinarians (ÖTÄK), which will make the registration.

The TÄ-HAPO identification number is assigned by the ÖTÄK. If you have not received your TÄ-HAPO-ID yet, please contact ÖTÄK.

The amendment to the Pharmacy Operating Regulations 2005 has made the obligations to keep records clearer. In the TÄ-HAPO all incoming and outgoing goods must be recorded. The obligation to keep these records electronically is a new addition.

The amendment to the pharmacy operating regulations introduces the obligation to keep records electronically. However, this is coupled with a longer transition period: you have until 31.12.2018 to convert the records of your TÄ-HAPO on an electronic basis.

Yes, a prescription is to be understood as a dispensing for use (by means of a prescription via a public pharmacy or other authorized bodies) and must be recorded accordingly in the dispensing report.

Veterinarians holding a TÄ-HAPO must - in addition to the obligation under the Apothekenbetriebsordnung 2005 to keep records of incoming and outgoing goods - submit an annual report on veterinary antibiotics supplied, separately according to the establishments to which such medicines were supplied (§ 7 Vet-AB-MengenströmeVO). The annual registration must be submitted by 31 March of the following year.

The future annual notification (notification of dispensing and notification of use) corresponds to the previously known form of notification if, as a veterinarian in charge of the TÄHAPO, you have dispensed veterinary medicinal products with antimicrobial active substances to food-producing animals in accordance with Section 7 (2) Vet-AB-MengenströmeVO.

The recording of the dispensing of antimicrobial agents to animal owners or farmers by veterinarians will be expanded in future - starting with the 2023 recording period - to include the recording of all prescriptions for medicinal products containing antimicrobial agents from January 1, 2023. In addition, from January 1, 2023, data from use in the actual sense, i.e. direct use on animals, must also be collected and reported for the first time from 2024.

The dispensing and use includes veterinary medicinal products with antimicrobial active substances authorized in Austria or throughout the EU, but also antimicrobial human medicinal products and antimicrobial medicinal products that are “rededicated” in the context of a therapeutic emergency or “imported” (= brought) to Austria under the Medicinal Products Import Act and used on animals by veterinarians or dispensed to their owners/keepers.

The group of ATCvet codes affected by the flow measurement will be published in the "Official Veterinary Bulletin".

The notification of the transfer only includes preparations that are transferred to the animal owner for the treatment of farm animals.

The delivery report, the application report and the voluntary detailed report (of the application) currently only affect veterinarians who treat agricultural animals in accordance with Section 7 Paragraph 2 Vet-AB-MengenströmeVO.

NEW: If you only treat small animals in your practice, you will be required to submit an electronic empty delivery report since 2022. This must be carried out independently on the portal after registering with AGES eServices and receiving the access data. The deadline for reporting is March 31 of the following year. If necessary, you can also have the empty report carried out by an approved reporting center (link zu dieser FAQ FAQ antibiotics flow - BASG). Transmission by email or post is not permitted.

NEW: If you, as a small animal practitioner, treat dogs and cats with antimicrobial medicines, prescribe such medicines to the pet owner via prescription for his/her animal(s) or antimicrobial medicines from your vet -HAPO to the animal owner, you are obliged to collect this data from January 1st, 2029 and for the first time in 2030 by March 31st to make the appropriate delivery report and application report. If necessary, you can also have the data reported by an approved reporting agency (link zu dieser FAQ FAQ antibiotics flow - BASG). Transmission by email or post is not permitted.

Currently, i.e. until 2027, according to the underlying regulation, the use of medicines with antimicrobial active ingredients in horses (including ponies) is exempt from the reporting requirement for the dispensing report and the application report.

NEW: If you only treat horses in your practice (and no other animals that provide food), you are obliged to submit an electronic empty delivery report since 2022. This must be carried out independently on the portal after registering with AGES eServices and receiving the access data. The deadline for reporting is March 31 of the following year. If necessary, you can also have the empty report carried out by an approved reporting center (link zu dieser FAQ FAQ antibiotics flow - BASG). Transmission by email or post is not permitted.

NEW: If you treat horses (including ponies) in your practice, regardless of whether they are intended for slaughter or are exempt from it according to the equine passport (“horse passport”), you are obliged to pay all tax fees from January 1, 2026. and to collect application data (dispensing, independent use or prescription) of drugs with antimicrobial active ingredients in horses and to report them for the first time in the following year, i.e. 2027, and annually thereafter. If necessary, you can also have the data reported by an approved reporting center (link zu dieser FAQ FAQ antibiotics flow - BASG). Transmission by email or post is not permitted.

Yes, because the dispensing notification, which must be submitted for the last time in the conventional form in 2023 for the 2022 registration period, includes antimicrobial veterinary medicinal products that are dispensed to the animal owner for the treatment of livestock/food-producing animals in accordance with Section 7 (2) Vet-AB-MengenströmeVO, including aquaculture animals. The notification must be made for at least the following fish species from aquaculture:

• Rainbow trout (Oncorhynchus mykiss),
• Atlantic salmon (Salmo salar) and
• carp (Cyprinus carpio).

NEW: from 2024, the new notification of dispensing and notification of use also includes antimicrobial veterinary medicinal products and antimicrobial human medicinal products that are dispensed to the animal owner for the treatment of the above-mentioned fish species, prescribed to the animal owner by prescription for their animals and also used directly by the veterinarian on the animals.

No. Medications with antibiotic active ingredients used by veterinarians themselves are not subject to the notification requirement. However, you can report them voluntarily via a coordinator.

Please contact one of the following recognised hotlines.

The voluntary reports are made via so-called coordinators (animal species-specific bodies such as QGV, ZAR, etc.). Please get in touch with these offices.

In principle, it is possible to place "collective orders". However, the individual TÄ-HAPO must be separated and broken down by TÄ-HAPO ID. An order with a single TÄ-HAPO-ID for all TÄ-HAPO on the same site is not permitted. Similarly, the annual declaration of the levy must be made separately for each TÄ-HAPO at the same location, but the declarations must also be made individually.

If you end your activity during the year, you are still required to submit a dispensing notification, application notification or empty notification for the year in question. This means that if, for example, you end your activity as a HAPO-managing veterinarian at the end of May 2024, you must submit a notification for the period from January to May 2024. Even after deregistration of the veterinary practice dispensary, it is technically possible to submit a notification in the following reporting year.

Recognised hotlines are responsible for the transmission of data for the annual reports of veterinarians concerning antibiotic duties. They must check the plausibility of the incoming messages and have functioning interfaces through which the data is transmitted to the AGES.

A test run must be carried out to check whether the technical requirements have been met. Please contact AGES (e-mail: basg-eservices@ages.at) if you have any questions regarding the procedure of the Vet-AB-MengenströmeVO. AGES will send a letter to the Federal Ministry of Health (BMG) confirming that you meet the technical requirements for the operation of a recognised reporting office within the meaning of § 7 para. 4f Vet-AB-MengenströmeVO. The BMG will publish a communication to this effect in the "Amtlichen Veterinärnachrichten" (AVN). Only with this publication in the AVN may you commence your activities as a recognised registration office.

It should be noted that recognised hotlines must carry out the processing of personal data in strict compliance with data protection requirements.

Change expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!

Coordinator take over the data transmission for the voluntary reports from veterinarians or keepers of animals concerning the use of antibiotics. They must check the incoming messages for plausibility, make them anonymous and have functioning interfaces through which the data is transmitted to the AGES. At the same time, the coordinators must also be in a position to transmit to AGES the mandatory notifications of the veterinarians for the species in question.

A test run must be carried out to check whether the technical requirements have been met. Please contact AGES (e-mail: basg-eservices@ages.at) if you have any questions about the procedure of this procedure. AGES will send a letter to the Federal Ministry of Health (BMG) confirming that you meet the technical requirements for operating a coordinator as defined in § 9 Vet-AB-MengenströmeVO. The BMG will publish a communication to this effect in the "Amtlichen Veterinärnachrichten" (AVN). Only with this publication in the AVN may you begin your activities as a coordinator.

No. The determination that you may become active as a coordinator presupposes that you also take over the obligatory notifications (= AB duties) for the animal species for which you act as a coordinator from the veterinarians you are looking after, in this respect also acting as a recognised registration office.

Yes, if the technical requirements are no longer met, your recognition as a registration office or as a coordinator expires. This fact is published by the BMG in the AVN.

Various catalogs (e.g. animal species, type of use) are made available on the BASG homepage under the data provision section (Provision of data - BASG). In the case of an extensive catalog with many values, there is the option of setting up an autocomplete function in the respective practice software (i.e. Autocomplete is a function that meaningfully complements a user input. The basis for completion is in any case a limited number of options, which are reduced in line with the progress and, if necessary, semantics of the user input.). Please contact your practice software manufacturer or supervisor.

The aggregated annual totals must be reported. Example: The veterinary medicine chest 1 buys 200 packs of product A and returns 50 packs of it in 2014. This results in an annual total of 150 packs of product A for the veterinary medicine chest 1.

These returns must then be taken into account in the declaration for the year 2015. example: The veterinary medicine chest 1 buys in the year 2014 of the product A 200 packs. This results in an annual total of 200 packs of product A for the year 2014 for the veterinary medicine chest 1. 50 packs will be returned in 2015 on 7 January and 150 packs will be purchased in the course of the year. This results in an annual total of 100 packs of product A for 2015 for the veterinary medicine chest 1.

The reporting deadline ends on March 31 of each year; in the case of returns between January 1 and March 31 (of relevant ASPs submitted in the reporting year), these can be taken into account or “deducted” directly in the submission report. If the surrender data has already been reported, a new complete report can be submitted with the corrected data.

A notification of dispensing or notification of dispensing and notification of use of veterinary medicinal products with antimicrobial active substances for use in food-producing animals is also required if products with antimicrobial active substances that are authorized in Austria but are not primarily authorized for the animal species treated or for the indication in question. for the indication in question, but which are dispensed or used directly for use in the animal species in question due to a therapeutic emergency, i.e. as part of a reclassification in accordance with Articles 112 - 114 of EU Regulation 2019/6 (formerly Section 4 para. 2 no. 1 of the Veterinary Medicinal Products Control Act (TAKG)).

This regulation applies to all livestock species for which a delivery for the use of reclassified veterinary medicinal products with antimicrobial active substances takes place.

No notification is currently required (until 2023) if veterinary medicinal products with antimicrobial active substances for use on food-producing animals are brought from another EU member state (“special import”) as part of a reclassification.

NEW: The notification of medicinal products with antimicrobial active substances for use on animals brought from another EU Member State for reclassification in accordance with Articles 112 - 114 of EU Regulation 2019/6 (formerly Section 4 para. 2 no. 2b) of the TAKG) is mandatory from the following years, staggered by animal species:

• Data collection from 2023 and notification from 2024 for food-producing animals
• Data collection from 2026 and reporting from 2027 for horses (incl. ponies)  
• Data collection from 2029 and reporting from 2030 for dogs and cats

NEW: Medicinal products with antimicrobial active substances that are authorized for use in humans in Austria and may be used in the context of reclassification (see ATC codes in the above-mentioned ordinance) must be reported in the following years, just like the exported medicinal products by animal species:

• Data collection from 2023 and reporting from 2024 for food-producing animals
• Data collection from 2026 and reporting from 2027 for horses (incl. ponies)
• Data collection from 2029 and reporting from 2030 for dogs and cats

Special imports are reported via the AWE notification by the authorized bodies according to §4 para.1 AWEG (e.g. wholesalers, public pharmacies). These reports are evaluated annually by AGES and are included in the volume flow reports. These medicinal products do not appear in the veterinarian-specific evaluations.

Change expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!

The different package sizes (numerical value) and package units (catalog) are provided in the master data download. The message must be in this form, since the system checks that the package size/unit is valid.

The quantity to be dispensed refers in principle to the published application unit as well as to the unit of the package size (e.g. "piece", "ml", "g", etc.) of the medicinal product. In the case of quantities in "pieces" such as udder injectors or tablets, it is only possible to report a partial quantity if a part (e.g. 10 pieces from a package of 20 pieces) is taken from a package of several pieces. The division of individual tablets or udder injectors is not intended.

The Animal Daily Dose (ADD) is a computational variable that is mainly relevant for the statistical evaluation of the data and not for the veterinarian on site. The ADD is the mean of the dosage data for an indication, active substance, target species and method of administration. ADD is expressed in mg/GVE (milligram per livestock unit) and not per kilogram of body mass. One LU corresponds to 500 kg. In the human area this size is called "Defined Daily Dose".

The PDD provides useful information for the veterinarian as it refers to the product the veterinarian is about to use - it is therefore "product related" and, like the dosage in the technical information, refers to one kg of live weight, is expressed in mg/kg bww (body weight) and is 80% of the maximum dosage.

The DDDvet, Defined Daily Dose for animals, and the DCDvet, Defined Course Dose for animals, were developed/defined specifically for the ESVAC (European Surveillance of Veterinary Antimicrobial Consumption) project by nine EU Member States based on the information on doses from the Summary of Product Characteristics of antimicrobial veterinary medicinal products. The main objective of the DDDvet and DCDvet system is to provide standardized units of measurement for reporting data on the consumption of antimicrobial veterinary medicines by species. Differences in dosage between the individual animal species and substances are taken into account. These conversion values are used to evaluate and compare data.

The maintenance dose is the amount of a drug/active substance (dose) that must be administered to achieve the desired effect. The drug/active substance does not necessarily have to be administered as a "permanent drip" (intravenous application) - each type of application approved for a drug (for administration via water or feed, application on the skin, subcutaneous application, intramuscular application, etc.) must be able to produce the concentration of active substance at the site of action required for successful therapy.

Since 2015, there has only been the option of electronic reporting via the AGES portal. An xml file filled with the relevant data (see scheme Meldung_Vertrieb.xsd) must be uploaded to the portal. Further information on registration on our portal can be found here: Veterinary Antimicrobial Consumption.

Change expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!

The annual notification - until 2023 only dispensing notification - is to be submitted electronically via the AGES portal. An xml file filled with the relevant data (see scheme Meldung_Abgabe.xsd) must be uploaded to the portal. Further information on registration on our portal can be found here: Veterinary Antimicrobial Consumption. The annual report can also be sent to a recognized reporting office. The form in which the data is to be transmitted must be clarified with the respective reporting office (a detailed list of the recognized reporting offices is published in the AVN).

The reporting office checks your report for plausibility and completeness of the data and transmits the data to AGES.

Change expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!

Notification of distribution is required for ALL veterinary medicinal products that contain antimicrobial active substances and are authorized for USEFUL ANIMALS and/or PETS in Austria, i.e. products that are authorized exclusively for pets or horses must also be notified. The veterinary medicinal products with antimicrobial active substances to be notified can be identified by their ATCvet code (see publication in the AVN).

For the 2023 distribution report, the distribution of antimicrobial veterinary medicinal products with the following ATCvet codes must be reported in accordance with the AVN - the ATCvet code of a veterinary medicinal product is specified in section 5 (or 4.1 for texts in the new QRD format version 9.0) of the Summary of Product Characteristics (SPC):

NEW: The ATCvet codes to be reported from 2024 can be found in the Annex to Regulation (EU) 2021/578. This Regulation distinguishes between ATCvet codes of antimicrobial veterinary medicinal products that must be reported and those with an ATCvet code that can be reported on a voluntary basis.

 Change to be expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!

Currently, i.e. for the 2022 recording period, notification of dispensing (dispensing notification) is required. This applies to veterinary medicinal products that contain antibiotic active substances and are authorized for at least one of the following food-producing animal species in Austria in accordance with § 7 (2) ABM-VO:

• cattle, sheep, pigs and goats and
• other ruminants, caudates, birds, domestic poultry, rabbits or aquaculture animals, provided they are intended for the production of food or other products for human consumption.

In addition, the respective ATCvet code of the veterinary medicinal product is the basis for the reporting obligation - the relevant ATCvet codes are published in the “Amtliche Veterinärnachrichten” (AVN).

According to the AVN, antimicrobial veterinary medicinal products with the following ATCvet codes must currently be reported - the ATCvet code of a veterinary medicinal product is specified in section 5 (or 4.1 for texts in the new QRD format version 9.0) of the Summary of Product Characteristics (SPC):

The Anatomical Therapeutic Chemical classification system for veterinary medicinal products is an internationally valid classification system officially published by the World Health Organization for medicinal products used in veterinary medicine. With the help of the ATCvet code, veterinary medicinal products can be divided into therapeutic categories. This makes it much easier to find veterinary medicinal products for certain indications and types of use (see https://www.whocc.no/atcvet/).

The ATCvet code usually consists of a combination of 8 letters and numbers. In the notification, the combination of letters and numbers listed in the “Official Veterinary Information” (see above), i.e. the first 4 or 6 digits of the ATCvet code, must match the ATCvet code specified in the product information under point 5 or 4.1. The last 2 or 4 digits can be disregarded, they only indicate active substance classes or the subgroup of an active substance.

Example of the structure of the ATCvet code based on the complete classification of ampicillin for systemic use: ATCvet code QJ01CA01

QJ - Anti-infectives for systemic use (1st level, main anatomical group)
01 - Antibiotics/chemotherapeutics for systemic use (2nd level, main therapeutic group)
C - Betalactam antibiotics (penicillins) for systemic use (3rd level, therapeutic subgroup)
A - Betalactam antibiotics, broad-spectrum penicillins for systemic use (4th level, chemical/therapeutic subgroup)
01 - Ampicillin (5th level, subgroup for the active substance)

The same classification system also exists for active substances used in human medicine. One difference is that the ATC codes only have 7 digits, they do not have a “Q” at the beginning (see https://www.whocc.no/atc_ddd_index/).

NEW: From 2024, not only antimicrobial veterinary medicinal products dispensed from the TÄ-HAPO must be reported, but also those prescribed to the animal owner by prescription for their animals or used directly by the veterinarian on the animals. In addition, any antimicrobial human medicinal products used for treatment must also be reported. The ATCvet or ATC codes for the dispensing notification and the notification of use can be found in the Annex to Regulation (EU) 2021/578 (see also table below). A distinction is made in this regulation between ATCvet/ATC codes of antimicrobial medicinal products that must be reported and those with an ATCvet/ATC code that can be reported on a voluntary basis:

The correct data for filling the fields "Approval number", "Package size" and "Package size unit" is best taken from the veterinary drug data record of the respective drug speciality in the download (Antibiotics Quantity Flow AnalysisASP.xml). When selecting the package size, the total quantity must always be indicated if bundle packs are permitted in addition to individual package sizes, e.g. for an oral solution or injection solution, where packages of 10 x 100 ml, 4 x 250 ml, 2 x 500 ml or 1 x 1000 ml are permitted, the package size must always be 1000 ml.

Change to be expected based on the amendment to the national Veterinary Antibiotics Volume Flow Regulation!

The "MelderID" is the same as the "HAPO-ID" in the event that you as a veterinarian report directly via the BASG portal. You can obtain these from the Chamber of Veterinarians after registering your veterinary medicine cabinet with the district administrative authority or at the Magistratische Bezirksamt (Magistrate District Office).

The detector ID for recognised hotlines is assigned as such by the implementing body after the notification. The registration form has been available for download on the BASG homepage since 1 December 2015.

The field 'LFBIS' (agricultural holding number) shall also be completed where veterinary medicinal products containing antibiotic active substances are supplied for the treatment of farm animals not belonging to a farm. Instead of the LFBIS, the VIS number can be entered here, if no VIS number is available, a so-called "dummy" number can be entered.

Currently there are the following "dummy" VIS numbers to be used for the notification of the levy in case affected keepers are unable to provide a VIS/LFBIS number:

• X399388 Dummy operation for small ruminants
• X399396 Dummy operation domestic poultry
• X399418 Dummy operation farm game

The correct data for filling in the fields "Approval number" and "Application unit" can be found in the download of the veterinary medicinal product data record of the respective medicinal product speciality. The "animal species" and the "usage type" for the target animal species concerned must be suitably selected from the catalogues "Animal species for notifications" (Catalogue_Animal species for notifications.xlsx) or "Usage type" (Catalogue_Usage type.xlsx) published on the BASG homepage.

For pigs, cattle, small ruminants and poultry, the appropriate type of use should be selected according to their use; for farmed game, llamas, ostriches and fish, the type of use should always be "Other".

Product information on centrally (throughout the EU) authorised veterinary medicinal products, identifiable by a marketing authorisation number associated with EU/2/... can be found in the Community Register of the European Commission. The Commission is responsible for publishing the latest version of the product information. A direct link to texts of centrally authorised veterinary medicinal products cannot be offered, as the Internet addresses of these pages may change continuously.

Should the data concerning your company be sent to the evaluating authority (AGES) via a bundler (with whom you have already concluded a data protection agreement), the latter will ensure that your data is anonymised when it is sent from the bundler's data processing system: Your LFBIS number is encrypted and sent to the AGES database. This does not allow any conclusions to be drawn about your company.

Please note that messages can only be sent in XML format.

Schema descriptions for data provision can be found here.

The following characters cannot be used because they have a special meaning in XML files and must be replaced as follows:

" --> "

' --> '

<font color="#ffff00">-==- proudly presents

Specific questions to medicinal products: basg-heve@basg.gv.at
Specific questions on notification and evaluation: ab-mengenstrom@ages.at
Technical questions: basg-eservices@basg.gv.at