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On 20 December 2017, the Council agreed its mandate for the "trilogue" negotiations with the European Commission and the European Parliament on the proposals of the veterinary medicines package.
The animal medicines package is a package of three proposals for regulations updating the existing legislative framework for veterinary medicines and medicated feed by tailoring it to the specificities of the animal health sector. While continuing to safeguard public and animal health, animal welfare, food safety and the environment, it aims in particular at:
- increasing the availability of veterinary medicines in the EU
- improving the functioning of the Union market
- reducing administrative burdens and fostering innovation
It also intends to strengthen the rules on use of antimicrobials in animals to better tackle antimicrobial resistance (AMR) in the EU. The package was published by the Commission on 10 September 2014.
During negotiations of regulation (EU) No 470/2009 (on procedures for establishing residue limits of pharmacologically active substances in foodstuffs), it was recognised that:
- veterinary medicines for certain animal species were not readily available
- as well as of the regulatory burdens hampering the optimal functioning of the Union market
The Commission proposed to modernise existing rules that will ultimately benefit:
- all animals (including aquatic species and bees)
- their holders and pet owners
- veterinarians and all related businesses in the EU (including the pharmaceutical and feed industries)
The three proposals under the animal medicines package concern:
Veterinary medicinal products
The proposal on veterinary medicinal products aims in particular to make more medicines available in the EU to treat and prevent diseases in animals.
Medicated feed
The proposal on the modernisation of medicated feed legislation now includes feed for pets in its scope. The idea is to ensure the appropriate standard of product quality and safety in the EU, while simultaneously paving the way for better treatments for diseased animals.
Medicinal products for human and veterinary use
This proposed regulation will amend regulation (EC) 726/2004 to take into account the fact that centralised marketing authorisation for veterinary products is being separated from that of human medicine.
Thursday December 21, 2017/ European Council/ European Union.
http://www.consilium.europa.eu/en/policies/animal-medicines-health-package/
