FAQ antibiotics flow

Legal questions

Why antibiotics flow measurement?

Antibiotics are among the most commonly prescribed drugs worldwide. With a market share of thirteen percent, they represent the largest single area after the total recording of our drug consumption. Antibiotics are used specifically as medicines in the treatment of humans and animals. There is a specific risk-benefit ratio for the therapeutic use of antibiotics in animals.

There are demonstrable connections between the use of antibiotics and the accumulation of antimicrobial resistance: the more frequently antibiotics of a certain group of substances are used in humans or animals, the more frequently bacterial pathogens that are insensitive to this substance are later found. The increase in resistance to antimicrobial agents poses a threat to public health, may prolong the duration of illness for patients, thus leading to higher health costs, and also has an economic impact on society.

In recent decades, livestock farming has changed for the purpose of producing animal food. Farm animals are being kept in ever larger units. The resulting increase in the density of livestock in the individual flocks facilitates the spread of infections. This in turn leads to an increased need and increased use of antimicrobial substances and thus to a selection of resistances to antimicrobial agents. This also supports the spread of resistant bacteria.

The use of antibiotics in livestock production cannot be justified if it aims at correcting deficiencies in husbandry systems or management errors. From a technical point of view, the use of antibiotics in animals is only indicated if bacterial infectious diseases are present. The efficacy of the antibiotic should be confirmed or verified by antimicrobial sensitivity testing of the causative bacterial culture. Antimicrobial pharmaceuticals are indispensable therapeutics, otherwise effective control of bacterial infections is hardly possible.

By recording the use of antibiotics in human and veterinary medicine, coordination between the two disciplines with regard to the use of active substances in animals will be easier in future. The frequency of use of so-called reserve antibiotics, i.e. those substances which are of particular importance for the treatment of infectious diseases in humans, is of particular interest for the assessment of possible risks, rather than the total quantity used in veterinary medicine.

What is the veterinary medicinal product dataset?

The veterinary drug dataset mentioned in § 3 of the Veterinary Antibiotics Quantity Flows Ordinance (Vet-AB Quantity Flows Ordinance) contains information on veterinary antibiotics and other veterinary medical specialities that veterinarians need for their supply or use. The dataset is kept up to date by AGES and can be downloaded under onlineService Veterinär Antibiotika Mengenstromanalyse.

You will find more detailed, up-to-date information on the supply and use of the respective veterinary medicinal product in the Technical Information and Instructions for Use - the link to this is contained in the dataset.

What are the reporting obligations under the Vet-AB-MengenströmeVO?

are obligated to report: 1) Companies that sell veterinary medicinal products with antibiotic active ingredients, whereby not only the distribution to veterinary pharmacies (TÄ-HAPO), but also to all the following bodies must be reported:

  • veterinary dispensaries
  • public pharmacies
  • Institutional Pharmacy of the University of Veterinary Medicine Vienna
  • Pharmacy(s) of the Austrian Armed Forces
  • other entitled bodies for which the Federal Ministry of Health issues an ID number

2) Veterinarians running pharmacies who supply veterinary medicines from their TÄ-HAPO to the animal owner.

Furthermore, on a voluntary basis, veterinarians and animal owners can report the directly used veterinary drug applications of vet antibiotics. However, there is no obligation for such notifications.

Why are voluntary reporting requirements laid down in a regulation?

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.

What is the TÄ-HAPO number?

In the course of the volume flow recording, a system was set up for easier identification of TÄ-HAPO: each TÄ-HAPO is assigned an individual, unmistakable number. This consists of the five-digit location number (professional seat of the veterinarian with federal state code) as well as the veterinarian number (also five-digit).

I am an entrepreneur and sell veterinary medicines with antibiotic active ingredients to veterinary pharmacies and/or other pharmacies. What are my duties?

Companies selling veterinary medicinal products with antibiotic active ingredients to veterinary pharmacies (TÄ-HAPO) and/or other pharmacies must keep records of these sales, which can be used to submit an annual report in accordance with § 6 Vet-AB-MengenströmeVO.

I am an entrepreneur and would like to submit my annual registration. What deadlines do I have to observe?

Annual reporting under the Vet-AB Quantity Flow Ordinance must be submitted by 31 March of the following year.

I am an entrepreneur and would like to know which preparations are affected by the mass flow recording.

The group of ATCvet codes affected by the flow measurement will be published in the "Official Veterinary Bulletin". You can find the link here.

The distribution notification covers all veterinary medicinal products containing antibiotic active substances and which are authorised for farm animals and pets in Austria, including those preparations which are only authorised for pets.

I am a veterinarian and would like to register a TÄ-HAPO.

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.

I am a veterinarian and would like to be added to the list of veterinarians who run a pharmacy. Do I have to do something actively?

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.

I am a veterinarian and would like to know how to get my TÄ-HAPO identification number.

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

I am a veterinarian and run a TÄ-HAPO. Which general recording obligations apply to me?

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.

I am a veterinarian and have a TÄ-HAPO, but I keep my records manually. What changes for me? Do I have to do something right now?

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.

I am a veterinarian and give veterinary medicines with antibiotic active ingredients from my veterinary medicine chest to pet owners. What are my duties?

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.

I am a veterinarian and would like to know which preparations are affected by the mass flow measurement.

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.

I am a veterinarian and exclusively treat small animals in my practice. Which duties meet me then?

The notification of the levy and the voluntary notification of application shall concern only farmed animals. If you only treat small animals in your practice, you are not obliged to register.

I am a veterinarian and also treat horses. Do I also have to indicate the medication I have dispensed for horses when recording the flow rate?

According to the amendment of the underlying ordinance, horses are exempted from the obligation to register.

I am a veterinarian and I use medications with antibiotic active ingredients for the treatment of animals. Do I have to take this into account when registering?

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.

I am a veterinarian and would like to submit my registration via recognised registration offices.

Please contact one of the following recognised hotlines

I am a veterinarian and want to participate in the voluntary system. How can I do that?

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.

I am a veterinarian and there are several veterinarians working at my place of work (e.g. in the form of a group practice or joint practice). Can the order of veterinary antibiotics or the annual declaration of supply by a person be accepted for a

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.

I would like to become a recognised registration office. What do I have to do? Which duties meet me then?

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.

I want to be a coordinator. What do I have to do? Which duties meet me then?

Bündler 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.

Can I become a coordinator without at the same time being a recognised registration office?

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.

Can I lose the status of a recognised hotline or a coordinator again?

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.

Questions on data provision and execution of notifications

How must returns be taken into account in the sales report?

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.

How must returns over several years be reported in the sales report, e.g. sales on 30.12.2014 and returns in 2015?

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.

Must a "notification of release" also be made in the case of an EMISSION, i.e. for veterinary medicinal products with antibiotic active substances which have been rededicated within the framework of a therapeutic emergency pursuant to §4 (2) TAKG?

A "notification of delivery" of veterinary medicinal products with antibiotic active substances for use in LW farm animals is also required if products with antibiotic active substances which are authorised in Austria but which are not primarily authorised for the treated animal species or for the indication in question but which are delivered for use in the animal species in question due to a therapeutic emergency, i.e. within the framework of a rededication pursuant to § 4 para. 2 no. 1 of the Veterinary Medicines Control Act (TAKG).

This scheme applies to all farm animal species subject to a levy for the use of rededicated veterinary medicinal products containing antibiotic active substances.

Medicinal products which are authorised for human use in Austria and which may be used in the context of rededication in accordance with § 4 (2) (2a) of the TAKG do not have to be notified, as only antibiotics which are authorised as veterinary medicinal products have to be registered in accordance with the AB-Mengenströme-VO.

No notification is currently required if veterinary medicinal products with antibiotic active substances are imported from another EU member state for use on LW farm animals as part of a rededication pursuant to § 4 (2) (2b) of the TAKG.

How must the package size or packaging unit be reported in the sales report?

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.

What quantity should be reported if only "half" packages are delivered?

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.

What is meant by domestic poultry (poultry, other - term from "Catalogue of animal species for notifications")?

This term covers poultry species other than chicken and turkey or ostriches, in particular the following species: Duck, goose, pigeon, partridge, guinea fowl, pheasant, quail, etc.

What does ADD mean?

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".

What does PDD mean?

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.

What does maintenance dose mean?

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.

What data does the veterinary medicinal product dataset contain ("master data download")?

The veterinary medicinal product dataset for farm animal antibiotics contains the complete large master dataset (see Annex 1 of the Regulation BGBl II 83/2014, item 1.1.1), which also includes information on dosage or duration of use. The veterinary medicinal product dataset for antibiotics which are exclusively authorised for pets also consists of the large master dataset, but those fields which do not represent a mandatory field are not filled here. Data required for the purpose of recording the antibiotic volume flows in accordance with the above-mentioned regulation, such as the dosage, are not listed. This information can be found in the respective technical and usage information (see link in the XML download).

For all other authorised veterinary medicinal products, the veterinary medicinal products dataset contains the so-called small dataset (see Annex 1 of the Regulation BGBl II 83/2014, point 1.1.2).

Are the data in the veterinary medicinal product datasets complete?

The primary objective of the project "Antibiotics Quantity Flows" and the master data download is to provide the data necessary for the EU-wide recording of consumption quantities and the calculation of ADDs for antibiotics for farm animals. These data are now fully available, except for a few farm animal antibiotics (see table), for which e.g. a procedure (e.g. prolongation of marketing authorisation, amendment application) is underway to update the data.

Due to the large amount of data to be entered that is required for the download, the master data for antibiotics for pets and for non-antibiotics are not available in their entirety. The AGES continuously supplements, updates and provides data on approved target animal species, the type of application, the currently approved package sizes as well as other data to be provided in the master data download of antibiotics for pets and other veterinary specialities within the framework of current procedures. The complete collection of the data should be completed by the end of June 2015. It should also be noted that missing data for repealed veterinary specialities can no longer be subsequently recorded. For those with ongoing procedures, the completion of the data sets will only take place after the completion of the procedures.

Technical and user information can also be accessed daily at https://aspregister.basg.gv.at/aspregister .

As a company I sell veterinary medicines with antibiotic active ingredients to veterinary medicine stores. When do I have to submit the first annual report on the distribution of veterinary medicinal products (TAM) with antibiotic active ingredients to a

The first annual report had to be submitted by 31 March 2015 at the latest for the year 2014. Now the reports must be made each year by 31 March for the previous year.

As a veterinarian I give veterinary medicines with antibiotic active substances from my veterinary medicine chest to pet owners. When do I have to submit for the first time the annual report on the distribution of veterinary medicinal products (TAM) conta

The first annual report had to be submitted by 31 March 2016 at the latest for the year 2015. Now the reports must be made each year by 31 March for the previous year.

As a company I sell veterinary medicines with antibiotic active ingredients to veterinary pharmacies and/or other pharmacies. What possibilities do I have to submit the annual report on the distribution of veterinary medicinal products (TAM) with antibiot

From 2015 onwards, only electronic reporting via the BASG portal will be possible. An xml file filled with the corresponding data (see scheme message_sales.xsd) must be uploaded to the portal. You can find more information about registration on our portal here.

As a veterinarian I deliver veterinary medicines with antibiotic active substances from my veterinary medicine chest. What options do I have to submit the annual report on the supply of veterinary medicinal products (TAM) with antibiotic active substances

The annual report is to be submitted electronically via the BASG portal. An xml.file filled with the corresponding data (see scheme Message_Duty.xsd) must be uploaded to the portal. You can find more information about registration on our portal here. However, the annual report (from 2016) can also be sent to a recognised reporting office. The form in which the data is to be transmitted must be clarified with the respective reporting office (a detailed list of recognised reporting offices is published here). The Reporting Office checks your report for plausibility and completeness of the data and transfers the data to AGES.

As a company I sell veterinary medicines with antibiotic active ingredients to veterinary pharmacies and/or other pharmacies. Do I have to report ALL products that contain antibiotic agents?

The notification of distribution is required for ALL veterinary medicinal products containing antibiotic active ingredients and approved for USETIERE and/or HEIMTIERE in Austria, i.e. such products are also subject to notification if they are approved exclusively for pets. The veterinary medicinal products with antibiotic active substances to be notified can be identified by their ATCvet code (see publication in the AVN).

As a veterinarian I give veterinary medicines with antibiotic active substances from my veterinary medicine chest to pet owners. Do I have to report ALL products that contain antibiotic agents?

The notification of delivery is required for veterinary medicinal products containing antibiotic active substances and approved in accordance with § 7 (2) ABM-VO for at least one of the following BENEFITS in Austria:

  • beef, sheep, pig and goat and
  • other ruminants, callosals, birds, poultry, rabbits or aquaculture animals 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 notification obligation - the ATCvet codes concerned are published in the "Amtlichen Veterinärnachrichten" (AVN).

 

Currently, AVN requires the notification of antibiotic veterinary medicinal products with the following ATCvet codes (the ATCvet code of a TAM is given in section 5 of the Summary of Product Characteristics (SPC)):

Categories of antimicrobially active substances

ATCvet code

Antibiotics for intestinal use

QA07AA . . . QA07AB . .

Antibiotics for application to the skin

QD06 . . . . .

Gynaecological antibiotics

Antibiotics for intrauterine use

QG01AA . . . QG01AE . . QG01BA . . . QG01BE . . QG51AA . . QG51AG . .

Antibiotics for systemic use

QJ01 . . . . .

Antibiotics for intramammary use

QJ51 . . . . .

Antibiotics against protozoan diseases (according to ASP register currently no upright approvals available)

QP51AG . .

The Anatomical Therapeutic Chemical classification system for veterinary medicinal products is an internationally valid classification system for drugs used in veterinary medicine, officially issued by the World Health Organization. The ATCvet code can be used to classify veterinary medicinal products into therapeutic categories. This makes it much easier to find veterinary medicinal products for certain indications and types of use.

The ATCvet code usually consists of a combination of 8 letters and digits. The combination of letters and numbers (see above), i.e. the first 4 or 6 digits of the ATCvet code, listed in the 'Official Veterinary Bulletin' must correspond to the ATCvet code listed in point 5. of the 'Technical Information'. The last 2 or 4 digits can be ignored, they only refer to antibiotic classes or the subgroup of an active substance.

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

QJ

=

Anti-infectives for systemic use (1st level, anatomical main 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)

As a company, did I receive an error message when I submitted my annual report? What do I have to pay attention to when registering for sales? Where can I get the necessary data for a correct report?

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.

As a veterinarian or a recognised registration office, have I received an error message when I submitted my annual registration via the BASG portal? What do I have to pay attention to when "Submitting a message"? Where can I get the necessary data for a k

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".

Why is there not a link to the respective technical and usage information for all veterinary medicinal products in the veterinary medicinal product dataset (master data download) or in the register of medicinal products?

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.

I am a farmer and worry about the anonymity of my data. How is the anonymisation of the data entering the database guaranteed?

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.

Technical questions

Which file formats are supported for messages?

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

Schema descriptions for data provision can be found here.

Which characters must not be used in the message XMLs?

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

" --> "

' --> '

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