作者

Dr. Daniel Tietjen

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作者

Dr. Daniel Tietjen

合伙人

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2022年5月18日

TAMG – the new Veterinary Medicinal Products Act

  • Briefing

The Veterinary Medicinal Products Act entered into force on 28 January 2022

Veterinary medicines in the European Union are governed by the Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC, which came into effect on 28 January 2022. At the national level, this prompted the German legislator to adopt a new, independent code – the Veterinary Medicinal Products Act (TAMG). Its objective, as set out in the explanatory memorandum of the Bundestag (printed paper 19/28658), is to ensure a high level of protection in using veterinary medicinal products and medicinal products for human use for animals, as they may impact the food chain, the quality of foodstuffs of animal origin, the environment, animal health, as well as public health through the development and spreading of antimicrobial resistance. The Regulation (EU) 2019/6 is applicable as well and further restricts the use of antibiotics in animals to curb the development and spreading of antimicrobial resistance.

Changes compared to the previous legal situation

Prior to the introduction of the TAMG, the laws on veterinary medicinal products were part of the German Medicinal Products Act (AMG). The new legislation separates the rules on medicinal products for human and for animal use into two separate bodies of special law, making their application considerably easier for veterinarians and animal keepers. However, the new § 50(2) TAMG drew a lot of criticism:

“Animal keepers and other persons who are not veterinarians shall use veterinary medicinal products subject to veterinary prescription, products of veterinary medical technology and medicinal products as defined in § 2(1), (2) and (3a) Medicinal Products Act for animals only if

  • they were prescribed or supplied by a veterinarian where the animals are in treatment, and if
  • they are used in compliance with veterinarian treatment instructions provided by the veterinarian for the particular case.”

The language of the provision includes all medicinal products for human use as defined in § 2(1), (2) and (3a) AMG into the restriction to veterinarians. As a result, animal health practitioners and animal keepers are not allowed to use human homeopathic products that are not subject to prescription and are registered, and their use is punishable as an administrative offence under § 89(2) No. 5, (6) TAMG. The motion for a preliminary injunction filed against this provision under § 32(1) BVerfGG (Federal Constitutional Court Act) was rejected by the Federal Constitutional Court’s order of 24 January 2022 (1 BvR 2380/21). The court explained that no substantiation had been provided showing reasons of particular significance for rendering a preliminary injunction. The exceptionally high thresholds for obtaining interim relief in connection with constitutional complaints were not reached. A preliminary injunction materially interferes with the legislator’s original competence and therefore can only be applied very restrictively. It remains to be seen whether the provision will hold up in the Federal Constitutional Court’s decision on the merits.

Outlook

The TAMG continues to implement the national concept to minimise use of antibiotics set out in the 16th AMG amendment, seeking to significantly reduce their use in livestock farming. At least the Federal Ministry of Food and Agriculture (BMEL), however, has identified a need for further improvement. More amendments could follow to further reduce the use of antibiotics.

Authors: Leoni König, Dr. Daniel Tietjen

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