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