Proposed new rules for veterinary medicines
The proposed new rules give particular attention to tackling AMR in both animals and humans.
Proposals for revised legislation for veterinary medicines and medicated feeds were published by the European Commission yesterday (September 10).
The proposals, which have been welcomed by the National Office of Animal Health (NOAH), aim to improve animal health, tackle antimicrobial resistance (AMR), make more veterinary medicines available in the EU and encourage the development of new medicines.
European commissioner for health Tonio Borg, said: "These proposals both have animal health and welfare at their heart. However, they also represent a major step forward for public health as they introduce measures that contribute towards combatting the growing threat of AMR, keeping antibiotics effective for people and animals alike."
NOAH chairman Phil Sketchley said: "With synergies with our own UK Government’s commitment to reduce unnecessary red tape, which is a key theme for Defra, the animal health industry in Europe needs greater efficiency to cut the red tape for our industry.
"We look forward to a streamlined registration process which delivers a single European marketing authorisation for all veterinary medicines."
The proposed new rules give particular attention to tackling AMR in both animals and humans. The amended regulation for medicated feed will explicitly include feed for pets. Stricter measures will be introduced to ensure it is used correctly, including a ban on the use of medicated feed as a preventative or growth promotor.
Mr Sketchley commented: "NOAH believes this is an important route for administering prescription medicines to animals. We will work to help ensure the legislation is capable of maintaining and strengthening this route."
According to the commission, the new rules for veterinary medicine aim to reduce red tape by simplifying the process of monitoring the adverse effects of veterinary medicines, and streamlining the procedure for marketing authorisation so companies can place and maintain medicines on the entire EU market.
Special rules will be introduced for the authorisation of veterinary medicines for small markets, such as apiculture and aquaculture. Extended data protection for innovative veterinary medicines will also make companies investments more worthwhile economically.
Rules will also be introduced to facilitate the internet retailing of veterinary medicines within the EU.
The proposals will be negotiated an agreed by European Parliament and European Council in due course.
Meanwhile, the Veterinary Medicines Directorate (VMD) plans to run stakeholder workshops to find out more about how the proposals will impact the affected industries.
To register your interest to take part in the VMD's workshop, send the name of the representative(s), name or your organisation and your specific areas of interest to Lorna Shelley l.shelley@vmd.defra.gsi.gov.uk
To find out more about the proposed new rules, visit the European Commission website: http://europa.eu/rapid/press-release_MEMO-14-522_en.htm
Companies marketing medicines for small pets exempt from authorisation must submit their annual return to the Veterinary Medicines Directorate (VMD) by 30 November 2026.
