EMA

healthy animals // healthy people Protecting consumer safety If a medicine is supposed to be used in a food-producing animal, it needs to be safe for people to eat the food that comes from this animal. The maximum residue limits (MRLs) recommended by EMA reflect how much residue of the veterinary medicine in food derived from a treated animal is safe for consumption. The MRL is established before the medicine for food-producing animals is authorised in the EU.

click

Support for innovation Medicines for animals – safe and effective The well-being of people and animals is closely interlinked. Medicines to treat and prevent diseases in animals promote their health and welfare. They also make it safer for people and animals to live in close proximity and protect the supply of food produced from animals. Medicines for animals undergo the same rigorous scientific assessment as medicines for human use.

EMA encourages research and development of new veterinary medicines. The Agency provides scientific and regulatory advice to help developers successfully translate progress in veterinary science into new medicines for animals. New technologies can lead to new types of medicines and therapies. EMA’s Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) provides guidance on development and authorisation.

Medicines for all creatures, great and small Developers of veterinary medicines take care of a wide range of animal species and diseases. When the market for veterinary medicines is very small, EMA stimulates the development of new medicines through its minor use / minor species (MUMS) or limited markets policy.

Companies that want to market a new veterinary medicine throughout the European Union (EU) submit an application for authorisation to the European Medicines Agency (EMA) which is then carefully evaluated by EMA’s scientific experts. An authorisation will only be recommended if the medicine’s benefits outweigh the risks for the animal, the owner and the environment.

A place for excellence

Every medicine in the EU is continuously monitored. New information received is scrutinised and, if necessary, EMA will change the way the medicine is used.

In the European regulatory network, the EU’s best and brightest minds work together for safe and effective medicines. Innovative medicines require specialised scientific expertise. Thanks to cooperation across the EU, EMA has access to the best scientific experts and can source the right people with the right expertise at the right time.

Incentives can include a reduction of the amount of data requested to support a marketing authorisation application as well as free scientific advice and reduced application fees.

For more information on how EMA works on veterinary medicines please visit our website.

Fighting antimicrobial resistance The rise in antimicrobial resistance shows the connection between animal and human health. The use of antimicrobials in animals can contribute to bacteria becoming resistant and these resistant bacteria may be transferred to people through food. The Agency supports global efforts to combat antimicrobial resistance through the collection of data on the use of antimicrobials in the veterinary sector in the EU. EMA also provides guidance on prudent use of antibiotics in animals to limit the development of resistant bacteria. EU AMR Action Plan

www.ema.europa.eu/vet

Healthy animals, healthy people - leaflet - European Medicines Agency

application for authorisation to the. European Medicines ... EMA encourages research and development of new veterinary medicines. The Agency ... Thanks to cooperation across the EU, EMA has access to the best scientific experts and can ...

920KB Sizes 0 Downloads 111 Views

Recommend Documents

EMA leaflet for patients - European Medicines Agency
authorisation application to EMA. Each new medicine is ... EMA encourages research and development of new ... in the EU, we have access to the best scientific.

and package leaflet for iopamidol - European Medicines Agency
Apr 26, 2017 - the required data and documents for the application to be valid. 27 ..... Usually these reactions become manifest as minor respiratory or. 241.

Report - European Medicines Agency
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.

Human Medicines Highlights Newsletter - European Medicines Agency
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.

Human Medicines Highlights Newsletter - European Medicines Agency
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.

Agenda - European Medicines Agency veterinary medicines ...
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung

Registration form - European Medicines Agency
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc.

Registration form - European Medicines Agency
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc.

Agenda - European Medicines Agency - europa.eu
Jun 18, 2018 - 27. 7.8.1. List of all applications submitted/expected and the COMP coordinatorship distribution of .... 5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one, EMA/OD/031/10 Glutathione-pegylated ...... Abbreviations / Acronyms.

Human Medicines Highlights Newsletter - European Medicines Agency
Implant used to help new bone develop in patients with spinal disc problems and leg fractures .... E-mail [email protected] Website www.ema.europa.eu.

Finasteride - European Medicines Agency - europa.eu
Apr 25, 2018 - Page 2/8. Product Name (in authorisation country). MRP/DCP. Authorisation number. National Authorisation Number. MAH of product in the.