16th AMG Amendment

Report of the BMEL on the Evaluation of the Antimicrobials Minimisation Concept introduced with the 16th Act to Amend the Medicinal Products Act

Infections caused by bacterial pathogens are treated with antimicrobials in both humans and animals. Resistant bacteria have the ability to protect themselves from the action of antimicrobials and thus impair the efficacy of these medicinal products.

The key to preventing antimicrobial resistance is the prudent and overall reduced use of antimicrobials in both human and veterinary medicine, particularly in the case of active substance classes that are deemed to have priority ("critical") for public health.
With the entry into force of the 16th Act to Amend the Medicinal Products Act on 1 April 2014, a system was established in Germany for the first time for the nationwide minimisation of antimicrobial use in animal keeping for certain fattening animals (known as "types of production" – fattening piglets, fattening pigs, fattening calves, fattening cattle, fattening chickens and fattening turkeys).

The core elements of the Antimicrobials Minimisation Concept (sections 58a to 58d AMG) encompass: the duty of the keepers of the above-mentioned fattening animals to send notifications about their livestock and their use of antimicrobials; the half-yearly calculation by the competent authorities of a farm-specific indicator ("treatment frequency per farm"), and the duty of the animal keepers to take steps to reduce their use of antimicrobials when it is higher than the nationwide totality of treatment frequencies (above the nationwide indicators).

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