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New EU Laws on Veterinary Medicines Planned

12 September 2014

EU - New proposals have been put forward that will make veterinary medicines more available in the EU to treat and prevent diseases in animals.

The European Commission has been given the go ahead to plans for veterinary medicinal products and medicated feed that are aimed at improving the health and wellbeing of animals, tackling antimicrobial resistance (AMR) in the EU and fostering innovation.

Alongside the proposals for veterinary medicines, the Commission aims to modernise the legislation surrounding medicated feed, bringing pets into the scope of the regulations.

The Commission said that the idea is to ensure the appropriate standard of product quality and safety in the EU, while paving the way for better treatments for diseased animals at the same time.

The proposed rules are designed to benefit animals – including aquatic species, their holders, pet owners, veterinarians and businesses - including the pharmaceutical and feed industries, in the EU.

Tonio Borg, European Commissioner for Health, 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 antimicrobial resistance (AMR), keeping antibiotics effective for people and animals alike.”

The National Office of Animal Health (NOAH) has backed the European Commission’s move to improve the availability of veterinary medicines throughout Europe.

NOAH chief executive Phil Sketchley said: “NOAH will be looking at the detail of the texts in the coming days and weeks, and reviewing their potential impact.

“We look forward to working with the VMD, who have called stakeholder workshops to examine the texts. We will also be supporting our European federation IFAH-Europe as they work determinedly with the European institutions over the coming years to support the Commission’s vision for a more efficient regulatory system for veterinary medicines in Europe.

“We believe the value our industry brings to society is very high, despite being quite a small sector. For example, veterinary medicines benefit public health by preventing zoonotic disease and supporting food security.

“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,” he added.

“We will also be considering if the text has any particular implications for the UK animal health market and access to medicines for our animals.”

NOAH has also applauded the revised medicated feed legislation.

“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,” Mr Sketchley said.

NOAH said that currently, the manufacturers of veterinary medicines struggle with a regulatory system with some serious flaws:

• A highly segmented internal market and regulatory framework characterised by high product development and licence maintenance costs, limiting availability particularly in smaller markets and for minor species,
• Insufficient protection of intellectual property which stifles investment in innovation,
• A disproportionately high administrative burden which diverts funds and expertise away from new product development and risks depriving animals of modern medicines and treatment options.

The Commission’s proposals aim to tailor legislation on veterinary medicines to the needs of the veterinary sector while continuing to ensure a high level of public and animal health and a safe environment.

The proposed Regulation builds upon existing EU rules for veterinary medicines which ensure that only medicines that have been granted a marketing authorisation can be placed on the market.

However, rules are simplified to ensure the development of suitable medicines for animals in the EU.

This reduction in red tape will concern both the marketing authorisation procedure and the monitoring of side effects (pharmacovigilance).

The proposed rules are particularly timely for minor species such as bees, goats, turkeys, horses etc. for whom available medicines are currently lacking.

To combat AMR and to help keep antibiotics effective in humans and animals, the proposal introduces the possibility of restricting the authorisation and use in animals of certain antimicrobials that are reserved to treat human infections.

The proposed Regulation will repeal and substitute the outdated Directive (90/167/EEC) on the manufacture, placing on the market and use of medicated feed.

After veterinary prescriptions, medicated feed is an important route for administering veterinary medicines to animals. Its aim is to harmonise the production standards and marketing of medicated feed in the EU at an appropriate safety level, and to reflect technical and scientific progress in this area.

The proposed rules will ensure that medicated feed can only be manufactured from specifically authorised veterinary medicines and by approved manufacturers.

AMR will be tackled through measures such as a ban on medicated feed being used preventively or as growth promoters.

EU wide residue limits for veterinary medicines in ordinary feed will also be established at a limit to avoid the development of AMR.

The scope of the proposal explicitly includes medicated feed for pets, so that pets – especially those with chronic diseases, can be treated more easily with innovative medicated pet food.

Other EU institutions, including the European Parliament and the Council, will consider the Commission’s proposals and will adopt their positions in due course, in accordance with the co-decision procedure.


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