Detailed Notes on Veterinary Medicines

Veterinary Medicines Overview

  • Veterinary Medicinal Product (VMP):
    • A substance or combination of substances that treats or prevents diseases in animals.
    • Used for restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action, or for medical diagnosis.

Legal Framework

  • Veterinary Medicines Regulations 1968:
    • Initially covered medicines for human and animal use.
    • Replaced by Veterinary Medicines Regulations in 2005, which are reviewed annually.
  • Veterinary Medicines Regulation (EU) 2019/6:
    • Updated the rules on authorization and use of veterinary medicines in the EU.
    • Became applicable on January 28, 2022.
    • Contains controls on manufacture, authorization, marketing, and post-authorization surveillance of medicines.
    • Supports the availability and safety of veterinary medicines and combats antimicrobial resistance.

Classification of VMPs

  • Prescription Only Medication (POM-V):
    • Prescribed by a veterinary surgeon.
    • Supplied by a veterinary surgeon or pharmacist.
  • POM-VPS:
    • Can be prescribed by veterinary surgeons, pharmacists, and suitably qualified persons (SQPs).
    • Requires an oral or written prescription.
    • Can be supplied by the same categories.
  • NFA-VPS:
    • For non-food animals.
    • No written prescription is required.
  • AVM-GSL (Authorised Veterinary Medicine - General Sale List):
    • Available freely over-the-counter (e.g., flea treatments).

Exempt Medicines

  • Small Animal Exemption Scheme (SAES):
    • Applies to aquarium fish, caged birds, ferrets, homing pigeons, rabbits, small rodents, and terrarium animals.
    • Allows VMPs for these pets to be marketed without a marketing authorization (MA) but excludes antibiotics, narcotics, or psychotropic substances.

Prescription Requirements

  • A written veterinary prescription must include:
    • Prescriber’s name, address, and qualifications.
    • Owner’s name, address, and animal identification.
    • Prescription date and quantity prescribed.
    • Dosage and administration instructions (specific dosage only, "as directed" is not acceptable).
    • Necessary warnings and withdrawal period if applicable.
  • Controlled Drug Prescriptions:
    • Must include additional details like the prescriber’s registration number and quantity in dosage units.

Record Keeping & Audits

  • Pharmacists:
    • Must maintain records for incoming and outgoing POM-V and POM-VPS for at least 5 years.
    • Audit of VMPs must be performed at least once a year, reconciling stock with records.

Labelling Requirements

  • General VMP Labeling:
    • Should include prescriber and owner info, date of dispensing, product details, dosage instructions, and warning statements.
  • Manufacturers’ Labels:
    • Must be in English and legible, detailing active ingredients, routing administration, expiry dates, and storage instructions.

Wholesale Dealing Regulation

  • Only manufacturers or holders of a wholesale dealer’s authorisation can supply veterinary medicines to authorized retailers.
  • Must keep records of wholesale transactions for a minimum of 5 years.

Advertising Standards

  • No advertisement of POM-Vs unless aimed at professionals (e.g., veterinarians).
  • POM-VPS may only be advertised as a price list targeted to qualified professionals.

Suspected Adverse Reactions Scheme

  • The Suspected Adverse Reaction Surveillance Scheme (SARSS) monitors reports of suspected SARs to VMPs and human medicines related to animal treatment.

Resources

  • VMD: Veterinary Medicines Directorate for comprehensive information on authorized veterinary medicines.
  • NOAH Data Sheet Compendium: Lists data sheets for many veterinary medicines authorized for use in the UK, accessible via the VMD website.