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Submit notification to the veterinary medicinal product dispensing quantity register (TAR)

Service Description

When dispensing veterinary medicinal products to veterinary in-house pharmacies and other recipients with the following active substances, you as a pharmaceutical company or wholesaler must submit an annual notification to the Veterinary Medicinal Products Dispensing Register (TAR):

  • antimicrobial active substances in accordance with Section 45(6)(1) of the Veterinary Medicinal Products Act (TAMG)
  • substances according to § 45 paragraph 6 number 2 of the Veterinary Medicinal Products Act (TAMG)

An updated list of veterinary medicinal products subject to notification is compiled by the Federal Office of Consumer Protection and Food Safety (BVL) each May and November from the official medicinal product information system (AmAnDa).

This list contains information that is necessary in order to be able to assign the respective medicinal product individually without any problems:

  • Authorization number (ZNR)
  • Unit of the reference quantity
  • All authorized pack sizes including the pack size factor

Process flow

You can submit the notification for the Register of Veterinary Medicinal Products Dispensed (TAR) to the Federal Office of Consumer Protection and Food Safety (BVL) online as follows:

  • Call up the web application "Tierarzneimittel-Abgabemengen-Register" (TAR) .
  • To apply for access data, please send an e-mail to TAM-Abgabemengenregister@bvl.bund.de.
  • After receiving the access data, please carry out a password reset.
  • Then log in to the web application "Tierarzneimittel-Abgabemengen-Register" (TAR).
  • Upload the XML schema created in advance according to the known specifications.
  • The web application automatically validates and checks your file. In the event of error messages, a corresponding correction must be made. In the event of unsolvable errors, send a support request to TAM-Abgabemengenregister@bvl.bund.de.
  • The BVL checks the data at the end of the reporting period and will contact you if there are any queries.

Requirements

You are a pharmaceutical company or wholesaler and supply veterinary medicinal products with the following active substances to veterinary in-house pharmacies and other recipients:

  • Substances with antimicrobial activity in accordance with points 1 and 2(5) and (7) to (10) of the Annex to Delegated Regulation (EU) 2021/578 supplementing Regulation (EU) 2019/6
  • Substances contained in one of the annexes to the Regulation on Substances with Pharmacological Activity in the version published on July 8, 2009 (Federal Law Gazette I, page 1768) or in Table 2 of the Annex to Regulation (EU) No. 37/2010

Which documents are required?

  • Creation and upload of a complete XML schema according to concrete specifications for the web application "Tierarzneimittel-Abgabemengen-Register" (TAR)

What are the fees?

There are no costs for you for reporting via the "TAM Abgabemengen-Register" reporting portal.

What deadlines do I have to pay attention to?

The reporting period starts at the beginning of January. The notification must be submitted in electronic form as an XML file by March 31 of each year.

Processing duration

Processing Time: 4 Months
The data is reported in the reporting period from January 1 to March 31 of each year. The data is then validated, processed and evaluated by the BVL by August 1st of each year. The reporters do not receive any extra feedback on their reported data after submitting the report.

Legal basis

Applications / forms

  • There is no legal remedy.

Appeal

  • Forms available: No
  • Written form required: No
  • Informal application possible: No
  • Personal appearance necessary: No
  • Online service available: Yes

Further Information

Author

Federal Office of Consumer Protection and Food Safety (BVL) - Division 323


Forwarding service: Deep link to the portal of origin

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry of Food and Agriculture (BMEL)

Professionally released on

27.03.2023

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

Start your request directly online:

Competent Authority

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL), Abteilung 3, Referat 323

Address
Mittelstr. 51-54
10117 Berlin, Stadt
Remark: z. For the attention of Dept. 3, Unit 323
E-Mail
Contact us
WWW
Information on veterinary medicinal product dispensing quantities on the website of the Federal Office of Consumer Protection and Food Safety (BVL)