Bundesportal | Submit notification to the Veterinary Drug Dispensing Registry (TAR).

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Publisher

Federal Ministry of Food and Agriculture (BMEL)

Last update or date of publication

March 27, 2023

Contact

The government service telephone number 115 – your point of contact for questions related to the federal, state and local.

Monday through Friday from 8:00 to 18:00 (and beyond these times in some regions).

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When dispensing veterinary drugs to veterinary home pharmacies and other recipients with the following active ingredients, you as a pharmaceutical company or wholesaler must submit an annual notification to the Veterinary Drug Dispensing Registry (TAR):

antimicrobial active substances according to § 45 paragraph 6 number 1 Tierarzneimittelgesetz (TAMG).
Substances according to § 45 paragraph 6 number 2 of the German Veterinary Medicinal Products Act (TAMG).

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

Marketing authorization number (ZNR)
Unit of the reference quantity
All approved package sizes including the package size factor

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

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

Preconditions

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

Substances having antimicrobial activity according to point 1 and point 2, paragraph 5 and paragraphs 7 to 10 of the Annex to Delegated Regulation (EU) 2021/578 supplementing Regulation (EU) 2019/6.
Substances included in one of the appendices of the Ordinance on Substances with Pharmacological Activity in the version published on July 8, 2009 (Federal Law Gazette I page 1768) or Table 2 of the Annex to Regulation (EU) No. 37/2010

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

Basis for legal action

Artikel 57 der Verordnung (EU) 2019/6

§ 45 Absatz 6 Tierarzneimittelgesetz (TAMG)

Legal Remedies

No legal remedy is given.

Procedure

You can submit the notification for the Tierarzneimittel-Abgabemengen-Register (TAR) online to the Federal Office of Consumer Protection and Food Safety (BVL) as follows:

Call up the web application "Tierarzneimittel-Abgabemengen-Register" (TAR) .
To request access data, please send an e-mail to TAM-Abgabemengenregister@bvl.bund.de.
After receiving the access data, please perform a password reset.
After that, 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 validates and checks your file automatically. In case of error messages, make the appropriate correction. In case 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 contacts you in case of queries.

Deadlines

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

Processing time

4 months
The data are reported in the reporting period from January 1 to March 31 of each year. The data are then validated, processed and evaluated by the BVL by August 1 of each year. The reporting parties do not receive any extra feedback on their reported data after submitting the report.

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