EU Council adopts new rules on veterinary drugs and medicated feed
The Council of the European Union has approved new rules on veterinary drugs and medicated feed in an action that responds to the intensification of the fight against antimicrobial resistance.
The package of medicines for animals is a package of three proposals for regulations that update the existing legislative framework for veterinary drugs and medicated feed, adapting it to the specificities of the animal health sector. While continuing to protect public and animal health, animal welfare, food safety, and the environment, the package is aimed especially at increasing the availability of veterinary drugs in the EU, improving the functioning of the EU market, reducing burdens administrative and encourage innovation.
The package of medicines for animals approved by the Council includes two new regulations on veterinary medicines and manufacture, commercialization and use of medicated feed.
In addition, it establishes changes in the existing rules on procedures for the authorization and supervision of medicines for human and veterinary use and the establishment of a European Medicines Agency. Among others:
- It clarifies and simplifies the procedures by which a marketing authorization can be granted to new medicines, thus reducing the administrative burden for companies, especially small ones.
- The use of antimicrobials in animals is better framed by limiting their use even more in animals that are not yet sick, but that may run the risk of becoming ill, both in the case of prophylaxis and in metaphylaxis.
- Certain critical antimicrobials are established for the treatment of certain infections in humans in order to preserve their effectiveness.
- The protection of European consumers against the risk of spread of ADR through imports of animals and products of animal origin is improved.
- Pharmacovigilance and controls are strengthened.
Regarding the new rules on medicated feed:
- Criteria are established for the approval of feed business operators and their obligations in the manufacture of medicated feed.
- Harmonized requirements are set to prevent cross-contamination of a non-target food with active substances
- The prescription and use of medicated food containing antimicrobials in food-producing animals is clarified.
- The use of medicated food for prophylaxis is prohibited.
The adopted regulations must be ratified by the European Parliament before being published and they will be fully operational as of the end of 2021.
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