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Act on the Enactment of a Veterinary Medicinal Products Act and on the Adaptation of Pharmaceutical and Other Regulations.

Type of law

This Act provides for the safe trade of the veterinary medicines and effectiveness of the products quality and guarantee. This Act is intended to provide a high level of protection for animal health, animal protection and the environment as well as public health. The Act consists of 6 Parts divided into 93 sections: (1) General Provisions; (2) Veterinary medicinal products in the scope of the EU Regulation 2019/6; (3) Requirement for veterinary medicinal products outside of the scope of the EU Regulation 2019/6; (4) Common Rules; (5) Penalty and fine regulations; and (6)Transitional provisions.
In the Subsections the Act provides for the reduction treatment with antibacterial substances, clinical trials and resistance monitoring, homeopathic veterinary products, reduce treatment with antibacterial substances, animal welfare, medicated feed, reduction of the treatment with antibacterial fabrics, antimicrobial substances and further restrictions on certain antimicrobial agents. On trade related sector the Act provides for the manufacturing permit, wholesale distribution permit and parallel trade in veterinary medicinal products, labelling, package insert and package size and prices.
There is one Appendix to Section 56 of the Act by the Federal Institute for Risk Application regarding Data to be communicated for the purpose of conducting a risk assessment.
Date of text
Entry into force notes
Entry into force of this Act is made in different dates for each relevant section. Please refer to Article 10 (Entry into Force) of the attachment to the Act.
Serial Imprint
Bundesgesetzblatt Year 2021, Part I, No. 70
Source language


Legislation Amendment
Original title
Gesetz zum Erlass eines Tierarzneimittelgesetzse und zur Anpassung arzneimittelrechtlicher und anderer Vorschriften