Dies ist die interne Entwicklungsumgebung des FIM Portals. Bitte nutzen Sie die produktive Umgebung.

Meldung an das Tierarzneimittelabgabemengenregister (TAM-R) Entgegennahme

Bund 99110048261000 Typ 1

Inhalt

Leistungsschlüssel

99110048261000

Leistungsbezeichnung

Meldung an das Tierarzneimittelabgabemengenregister (TAM-R) Entgegennahme

Leistungsbezeichnung II

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

Leistungstypisierung

Typ 1

Begriffe im Kontext

nicht vorhanden

Leistungstyp

Leistungsobjekt mit Verrichtung

Leistungsgruppierung

-

Verrichtungskennung

Entgegennahme (261)

SDG Informationsbereiche

  • Erlangung von Lizenzen, Genehmigungen oder Zulassungen im Hinblick auf die Gründung und Führung eines Unternehmens

Lagen Portalverbund

  • Statistische Erhebungen und Meldepflichten (2090200)

Einheitlicher Ansprechpartner

Nein

Fachlich freigegeben am

27.03.2023

Fachlich freigegeben durch

Federal Ministry of Food and Agriculture (BMEL)

Handlungsgrundlage

Teaser

If you, as a pharmaceutical company or wholesaler, dispense certain veterinary drugs containing antimicrobials or certain substances to veterinary home pharmacies or other recipients, you must report the quantities annually to the Veterinary Drug Dispense Quantity Registry.

Volltext

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

Erforderliche Unterlagen

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

Voraussetzungen

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

Kosten

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

Verfahrensablauf

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.

Bearbeitungsdauer

4 Monat(e)
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.

Frist

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.

Weiterführende Informationen

Hinweise

nicht vorhanden

Rechtsbehelf

  • No legal remedy is given.

Kurztext

  • Notification to the Veterinary Medicinal Product Dispensing Quantity Register (TAM-R) Receipt.
  • Pharmaceutical companies and wholesalers are subject to an annual notification obligation for the Tierarzneimittel-Abgabemengen-Register (TAR) if they dispense veterinary drugs with the following active ingredients:
    • antimicrobially active substances according to § 45 paragraph 6 number 1 Tierarzneimittelgesetz (TAMG).
    • Substances according to § 45 paragraph 6 number 2 Veterinary Medicinal Products Act (TAMG)
  • an updated list of notifiable veterinary medicinal products is compiled each May and November by the Federal Office of Consumer Protection and Food Safety (BVL) from the official Medicines Information System (AmAnDa)
  • the list contains information that is necessary in order to be able to assign the medicinal product individually without any problems:
    • Marketing authorization number (ZNR)
    • unit of the reference quantity
    • approved package sizes including the package size factor
  • Notification takes place online via web application "Tierarzneimittel-Abgabemengen-Register" (TAR)
  • responsible: Federal Office of Consumer Protection and Food Safety (BVL)

Ansprechpunkt

nicht vorhanden

Zuständige Stelle

nicht vorhanden

Formulare

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