FAQ antibiotics flow
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.
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 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 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 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: email@example.com) 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: firstname.lastname@example.org) 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.
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.
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 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.
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.