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Tuesday 11 December 2018

New EU rules will see critical antibiotics set aside for human use only

The World Health Organisation warns antibiotic resistance is one of the biggest threats to
global health, food security and development. Stock picture
The World Health Organisation warns antibiotic resistance is one of the biggest threats to global health, food security and development. Stock picture
Ciaran Moran

Ciaran Moran

The EU is introducing new and improved rules to step up the fight against antimicrobial resistance and improve the availability and safety of veterinary medicines and medicated feed.

It said this will be of benefit to animal health and help boost the competitiveness of the EU veterinary pharmaceutical sector.

The Council today adopted the animal medicines package including two new regulations on veterinary medicinal products and the manufacture, placing on the market and use of medicated feed.

The new rules on veterinary medicinal products clarify and simplify the procedures through which a marketing authorisation can be granted to new medicines, thereby reducing the administrative burden for companies, especially small ones

The new rules also better frame the use of antimicrobials in animals by further limiting their use for animals that are not yet sick but may run the risk of falling ill, both in the case of preventing disease in individual and groups of animals.

They also provide for certain critical antimicrobials to be set aside for the treatment of certain infections in humans in order to preserve their effectiveness and improve the protection of the European consumers against the risk of the spreading of Antimicrobial Resistance through imports of animals and products of animal origin.

The new rules on medicated feed set out criteria for the approval of feed business operators and their obligations when manufacturing medicated feed

They also lay down harmonised requirements in order to avoid cross contamination of a non target feed with active substances and clarify the prescription and use of medicated feed containing antimicrobials in food-producing animals.

The Council and the European Parliament now need to sign the adopted regulations. The signed texts will then be published in the EU Official Journal and will enter into force 20 days later. However, the new rules will only be fully operational as of end of 2021.

“This package is a major milestone in the fight against antimicrobial resistance: on the one hand antimicrobials and antibiotics will have to be used much more prudently than is the case now, and on the other hand we encourage the development of better medicines and medicated feed.

“It is a win-win for public health and the competitiveness of the EU pharmaceutical industry, said Elisabeth Köstinger,” Austrian Federal Minister for Sustainability and Tourism and President of the Council.

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