There are several different classifications of veterinary medicines – it’s a lot more complex than “prescription” or “over the counter”! And each of these categories have different rules for how (and by who) they can be sold, and the requirements for licensing and marketing. In this article, we’re going to look at one category that you may not have come across – “SAES”, also known as ESPA, products.  

Authorised veterinary medicines and prescriptions 

Authorised veterinary medicines fall within one of four categories, which were established by the Veterinary Medicines Regulations. In the UK there are two classes of medicines available only on veterinary prescription, POM-V and POM-VPS. Only in the case of POM-V medicines does that veterinary prescription have to be issued by a qualified veterinary surgeon.  

The act of prescribing is taken to be the decision made by the prescriber as to which product should be supplied taking account of: 

  • the circumstances of the animals being treated 
  • the available authorised veterinary medicinal products 
  • the need for responsible use of medicines and the requirement to prescribe the minimum amount of product necessary for the treatment (subject to the minimum pack size manufactured and any authority to break bulk in the Regulations). 
  • the abilities and competence of the person who will administer the product; and 
  • any available animal health plan. 

Other medications have lower requirements for oversight; however, reasonable due diligence is required when NFA-VPS medicines are sold, including very similar levels of checks to those in the POM-VPS category. 

What are the different veterinary medicines? 

The veterinary classifications of POM-V, POM-VPS, NFA-VPS, AVM-GSL, and CD are all established and regulated by the VMD in the UK. 

  1. POM-V (Prescription Only Medicine – Veterinarian): These are veterinary medicines that can only be prescribed by a veterinary surgeon. Examples of POM-V medicines are antibiotics and steroids. 
  1. POM-VPS (Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person):  These are veterinary medicines that can be prescribed by a veterinarian, pharmacist, or a suitably qualified person. Examples of POM-VPS medicines include farm animals’ and horses’ worm treatments and some farm animal vaccines. 
  1. NFA-VPS (Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person): These are veterinary medicines that can be prescribed by a veterinarian, pharmacist, or a suitably qualified person for non-food animals, i.e. pets (but not horses). Examples of NFA-VPS medicines include flea, tick and worm treatments. 
  1. AVM-GSL (Authorised Veterinary Medicinal Product – General Sales List):  These are veterinary medicines that can be sold directly to the public without the need for a prescription. Examples of AVM-GSL medicines include some supermarket-type flea and worm products. 
  1. CD (Controlled Drugs):  These are veterinary medicines that are subject to legal controls under certain legislation including the Misuse of Drugs Act 1971 & Misuse of Drugs Regulations 2001. These medicines have the potential to be misused, and their use is strictly controlled to prevent harm to animals and humans. Examples of CD medicines include opioids and sedatives. 

An extra category… 

However, did you know that there is an additional category of veterinary medicines in relation to veterinary products intended solely for use in small, non-food producing animals, including: 

  • aquarium animals, including fish only kept in closed water systems. 
  • cage birds; birds kept in cages or aviaries. 
  • homing pigeons; pigeons kept for racing or exhibition. 
  • terrarium animals including reptiles, amphibians and arthropods kept in tanks and cages, including animals free-living in domestic gardens. 
  • small rodents 
  • ferrets 
  • rabbits 

Chickens, ducks, and turkeys are classified as food producing animals and so medicines for these species are not, under any circumstances, covered by the exemption. 

Any medicines for the small animals can have medication under the Small Animal Exemption Scheme (SAES) products. They are not authorised (so they have not been assessed for quality, safety, or efficacy) but may be legally marketed and administered according to the instructions on their labelling. 

Although such products are exempt from the requirement to hold a Marketing Authorisation, these products are still legally classed as veterinary medicines. Therefore, they must meet all the requirements of the VMR (Veterinary Medicines Regulations) relating to the manufacture (GMP) of veterinary medicines. Exempt medicines can only contain active substances which have been approved for the purposes of this exemption by the Secretary of State. 

You might also sometimes see these listed as “ESPA” too – this is the same, it’s just that some bodies refer to “Exemption for Small Pet Animals” and others rearrange the acronym and phrase it as “Small Animal Exemption Scheme” instead! 

What medicines not included in the exemption? 

The following medicines are never covered by this exemption: 

  • antibiotics 
  • narcotic substances 
  • medicines that may be used as a test to achieve a medical diagnosis.  

If it is a small animal product, will I get a label showing instructions? 

Exempt products must be clearly labelled to show that they are exempt from having a marketing authorisation, for example, by including the following statement on the outer packaging: 

  • name of the product 
  • the authorisation number of the manufacturer (note, this is the manufacturer’s reference, not the drug’s) 
  • name and strength of each active substance 
  • route of administration 
  • batch number 
  • expiry date 
  • the words, For animal treatment only 
  • contents by weight, volume, or the number of unit doses 
  • name and address of the manufacturer or distributor 
  • target species 
  • the words, Keep out of reach of children. 
  • storage instructions 
  • the shelf life after the immediate packaging has been opened for the first time. 
  • disposal advice 
  • full indications, including: 
  • therapeutic indications 
  • contra-indications 
  • interaction with other medicines and other forms of interaction 
  • dosage instructions 

What pack size will I receive? 

Exempt products must only be sold in pack sizes suitable for a single course of treatment. The VMD considers this condition should be met by ensuring that packs contain only sufficient product to treat the following numbers of animals until symptoms are sorted or, for preventative treatments, up to six months. 

Examples include: 

  • Aquarium: a single course of treatment should be no more than seven administrations to an aquarium of up to 25,000 litres.  
  • Cage birds and homing pigeons: to treat no more than fifty birds. 
  • Terrarium animals: to treat no more than five animals. 
  • Small rodents: to treat no more than five animals. 
  • Ferrets: to treat no more than five animals 
  • Rabbits: to treat no more than five animals. 

What if I notice adverse effects? 

Manufacturers and importers must report any serious adverse event within 15 days of becoming aware of it; and must keep records of all adverse events for 3 years, which they must make available on request. If you notice any adverse effects from a product on your small animals, then you must contact the manufacturer or, if you cannot, the VMD.  

What if my pet is unwell? 

If you have any concerns about your pet, it is good practice to seek veterinary advice where a vet can treat and prescribe the correct product for your pet. 

Further Reading: 

Legal Categories – NOAH 

ESPA Products – VMD