Topics and Briefing Documents

Controls on Animal Medicines

Before an animal medicine can be sold in the UK it must be approved. This takes the form of a marketing authorisation. The UK has one of the most stringent licensing systems for the authorisation of animal medicines in Europe, if not the world.

The Licensing Authority will only grant a marketing authorisation if the veterinarians, pharmacists, chemists, toxicologists and environmental experts, either at the VMD in the UK or EMEA for products seeking EU-wide approach, and their advisory committees of independent experts (the Veterinary Products Committee in the UK or CVMP in Europe), are fully satisfied.

To get the authorisation, it is necessary to prove that the product is safe, that it will work, and that it is of good quality.

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Briefing Documents

• Controls on Animal Medicines
• Safety of Food and Maximum Residue Limits
• Common Questions about Medicines for Farm Animals
• Pharmacovigilance: Monitoring Suspected Adverse Reactions to Animal Medicines
• Poultry medicines
• The cascade and human generic products
• Consumer attitudes to animal medicines
• Risk assessment and veterinary medicines
• Legal categories and veterinary prescriptions
• IFAH brochure: promoting a positive environment for veterinary medicines (the case for separate regulation for the animal medicine sector)
• IFAH-Europe - The animal health industry and regulatory reform: the 1-1-1 concept in a nutshell

Further information

• The Veterinary Medicines Regulations 2007 (or PDF version)
• Veterinary Medicines Guidance Notes issued by VMD
• The Marketing Authorisation Process for Veterinary Medicinal Products in Europe - detailed dossier or summary leaflet
• Veterinary Medicines Directorate (VMD)
• VMD Leaflet: Is this medicine safe for my pet?
• European Medicines Agency (EMEA)

Press releases

• NOAH supports European Antibiotic Awareness Day with its Responsible Use campaign (17 November 2009)
• 'Use medicines responsibly' - new guidance from NOAH (6 October 2009)
• Animal health in Europe: NOAH spells out priorities to MEPs (26 May 2009)
• The Veterinary Medicines Regulations 2005 - and you! (27 October 2005)
• VMD informal reaction on advertising goes 'a long way but not far enough' to answer communication concerns, says NOAH (20 April 2005)
• NOAH calls for tighter controls on use of human medicines by vets (20 April 2005)
• Enforcement of appropriate controls welcomed for animal medicines as RSPB report highlights pesticide issues (17 January 2005)
• NOAH conference to emphasise link between healthy animals and safe food (21 September 2004)
• NOAH emphasises the need for PML category for pets (12 July 2004)
• New UK regs need to allow best communication and advice for farmers: NOAH (12 July 2004)
• Don't give your pet a taste of your own medicine! (7 April 2004)
• Feed additives vote in European Parliament (9 December 2002)
• Pharmacovigilance: Monitoring Suspected Adverse Reactions to Animal Medicines - a new briefing document from NOAH (8 December 1999)
• Animal Medicines - what to do if you suspect an adverse reaction (3 June 1999)