Veterinary Medicines Directorate
If you are a:
- vet
- pharmacist
- Suitably Qualified Person (SQP)
- retailer
- horse owner or keeper
you must comply with certain legal requirements when administering medicines to and recording the use of medicines in horses.
Horses, ponies, donkeys and related animals (including zoo species like zebras) are considered to be food-producing animals in the UK.
All horses must have a passport with the exception of semi wild horses in areas such as the New Forest Semi-wild ponies only need a passport if they are under your control (for example if they wear a saddle or are on a farm). In the passport horses can be declared as either intended for human consumption (food-producing) or not intended for human consumption (non-food-producing).
Whether or not a horse is declared as intended for human consumption determines what medicines can be administered to the animal and the records that have to be kept.
Medicines for horses
Horses should be treated with veterinary medicines which have a UK marketing authorisation (MA) for use in horses as the first choice, or a GB or NI MA in the applicable territory. If there is no suitable authorised medicine available, for animals under their care a vet may prescribe an alternative medicine under the prescribing cascade.
However, a food-producing horse can only be treated with:
- a veterinary medicine that contains an active substance(s) in the legally permitted essential substances list for such horses (see below)
- a veterinary medicine containing pharmacologically active substances that must have a Maximum Residue Limit (MRL), but not necessarily in the species for which it is intended to be used. When checking this, prescribers should also consider the other provisions listed with the MRL
- for use in NI allowed substances are listed in table 1 in the Annex to Regulation (EU) No. 37/2010
- for use in GB substances with an MRL are listed in the GB MRL Register as established under Article 14A of retained Council Regulation 470/2009.
Essential substance list for horses
There is a list of substances considered essential for the treatment of equidae that may be used in food horses legally. These substances can only be used with a withdrawal period of six months.
The withdrawal period is the time between the last dose given to the animal and when the animal can be slaughtered for human consumption. The animal or its products must not be consumed until the withdrawal period has ended.
If any substance which is not on this list or is not listed in Table 1 of 37/2010, such as phenylbutazone, is administered to an animal, that animal must be permanently excluded from the food chain and the declaration in the passport signed by either the horse owner, its keeper or the vet.
Selection of medicines for horses
If, as a vet, pharmacist or Suitably Qualified Person you prescribe, administer or dispense any medicine for use in a horse you must:
- ask to be shown the passport for the horse if you do not have prior knowledge of its status (if you have seen the passport recently and are aware of the horses current status, you do not have to see it before each treatment)
- satisfy yourself that the passport supplied relates to the horse in question
- note whether the horse is declared as intended for human consumption in the passport or there is no declaration or the horse is declared as not intended for human consumption. If the declaration is not signed, you must consider the horse as being intended for human consumption
- satisfy yourself it is a valid passport (if the document does not contain Section IX, it is not a valid horse passport)
If you do not have prior knowledge of the horses status and a passport is not available, or if you are not satisfied that the passport relates to the horse in question, follow the Horse is presented without passport procedure.
Horse declared not intended for human consumption
You should treat the horse with veterinary medicines which have a UK MA for use in horses as the first choice. The Product Information Database holds information on every veterinary medicine authorised for use in the UK.If there is no suitable authorised product available, the cascade may be used to prescribe an alternative medicine.
Horse declared intended for human consumption or no declaration made
You must consider the types of product that can be used and information to be entered on the passport.
Type of product - Products authorised for food-producing horses, in the UK or outside of the UK (imported under a Special Import Certificate (SIC)) containing pharmacologically active substances which are listed in Table 1 of Regulation EU 37/2010 and have a determined withdrawal period for horses.
Passport record - Meat and milk withdrawal period as stated on the product label and in the SPC must be followed and recorded but this does not need to be in the passport.
Type of product - Veterinary medicines authorised in the UK or outside of the UK (imported under a Special Import Certificate (SIC)) which contain an active substance which is allowed to be administered to one or more food-producing species in accordance with Table 1 of Regulation EU 37/2010. This includes authorised products for other food-producing species and some products indicated for non-food-producing horses.
These products may only be prescribed by a vet under the cascade provisions.
Passport record - It is the responsibility of the vet to set a suitable withdrawal period. This must be recorded but this does not have to be in the passport. The withdrawal period must be at least 28 days (meat) or 7 days (milk) or the withdrawal period in the SPC of the product, whichever is longer.
Type of product - Products containing active substances in the list of essential substances. This list relates to both authorised veterinary medicines and extemporaneously prepared medicines containing these substances. These products may only be prescribed by a vet under the cascade provisions.
Passport record - The details of the essential substances administered and the date of last administration as prescribed must be recorded in the passport. A statutory six months withdrawal period must be set and the owner or keeper notified of this.
Product types that cannot be used
The use of any products, such as phenylbutazone, that contain an active substance which is not contained within Table 1 (the allowed list) of Regulation EU 37/2010 or on the essential substances list will automatically mean that the horse must be permanently excluded from the food chain.
Medicines containing substances included on the Prohibited Substances, Table 2 of Regulation 37/2010. As a vet, you should check this list regularly for changes.
If a product from either of these categories is administered to an animal, that animal must be permanently excluded from the food chain and the passport declaration should be completed at Part II of Section IX by the owner or by the vet.
The wording on the SPC and product literature for these types of product (when authorised for use in non-food horses) would usually read as follows:
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
To allow label harmonisation with such products authorised in several Member States, some products may state on the label:
Treated horses may never be slaughtered for human consumption.
Some veterinary medicines have been authorised in the UK that contain active substances in the allowed substances list, but are indicated for use in non-food horses only. This is because the manufacturers did not intend to market these products for food-producing horses and therefore did not undertake the tests that would be required to provide residue depletion data.
The wording on the SPC and product packaging would read as follows in these cases:
Not authorised for use in horses intended for human consumption.
Horse presented without a passport
If the owner or keeper of a horse does not have the passpor