Veterinary medicines regulations
DoH has a statutory obligation to ensure compliance with legislative requirements in all areas of medicines control as applies within and ouHeading 4twith Health and Social Care.
The Veterinary Medicines Regulations (the Regulations) provide that the DoH and/or Department of Agriculture and Rural Development (DARD) may exercise powers, in Northern Ireland, to appoint inspectors, issue seizure notices, publicise improvement and seizure notices and approve premises for suitably qualified persons.
A service level agreement is in place between the DoH and the Veterinary Medicines Directorate (VMD) in respect to inspection, by the VMD’s inspectors, of veterinary practice premises, wholesale dealer’s authorisation holder’s premises and premises approved for the retail supply of veterinary medicinal products by suitably qualified persons.
This agreement also covers improvement and seizure notices and ensures a consistent and equitable approach to inspections throughout the UK.
The DoH has responsibility for enforcement activity, with regard to the Regulations, within Northern Ireland, in accordance with a memorandum of understanding between the DoH and DARD.
An agreement between the DoH and the VMD allows the VMD to perform the function of approving premises suitable for the storage and supply of veterinary medicinal products by a suitably qualified person.
Register of approved premises
Inspection of Veterinary Practice Premises in Northern Ireland is in accordance with a memorandum of understanding in operation between the Royal College of Veterinary Surgeons and the VMD, and in accordance with the service level agreement in place between the DoH and the VMD.
Details of the wider functions carried out by DARD, and more specifically those related to animal health and welfare.
Veterinary medicines regulations
The Veterinary Medicines Regulations were introduced in 2005. The Regulations consolidated all regulations pertaining to veterinary medicines into a single set of regulations which are amended annually.
The Regulations govern the animal health industry and establish the Veterinary Medicines Directorate (VMD) to be responsible for the Regulations.
The 2013 Regulations are currently in force
Veterinary medicines fall into four distribution categories:
- prescription only medicine – Veterinarian (POM-V)
- prescription only medicine – Veterinarian, Pharmacist, Suitably Qualified Person (POM-VPS)
- non-food animal – Veterinarian, Pharmacist, Suitably Qualified Person (NFA-VPS)
- authorised veterinary medicine – General Sales List (AVM-GSL)
Veterinary surgeons, pharmacists and Suitably Qualified Persons (SQPs) are collectively known as Registered Qualified Persons (RQPs) and are entitled to prescribe veterinary medicinal products.
An RQP may only prescribe and/or supply the products that fall within the scope of the qualification and registration they hold. It is the duty of the RQP to ensure that the statutory requirements in respect of the prescription and/or supply of POM-V, POM-VPS and NFA-VPS are respected.
The prescribing and/or supply of POM-V, POM-VPS and NFA-VPS medicines may only take place from:
- premises registered with the Royal College of Veterinary Surgeons as a veterinary practice premises
- a pharmacy registered with the Pharmaceutical Society of Northern Ireland, in Northern Ireland, or the General Pharmaceutical Council in Great Britain
- premises registered with the VMD acting on behalf of the Secretary of State
The VMD Guidance Note 3 – Guidance for Retailers describes the provisions for prescription and supply of the different distribution categories of veterinary medicinal products in the UK.
Veterinary medicines advice for pharmacists
The Veterinary Medicines Directorate (VMD) is responsible for:
- assignment, issue and maintenance of Marketing Authorisations (MAs) for veterinary medicines in the United Kingdom
- controls on the manufacturing and distribution of veterinary medicines
- surveillance for residues (DARD in Northern Ireland)
- advising ministers
- establishment of the Inspections and Investigations Team (IIT)
- approving the Animal Medicines Training Regulatory Authority
Guidance notes on regulations
The VMD has issued a series of guidance notes on the Regulations:
- controls of veterinary medicines
- marketing authorisations for veterinary medicinal products
- guidance for retailers
- controls on advertising
- import certificate schemes
- animal test certificates
- guidance on the homeopathic registration scheme
- wholesale dealer’s authorisations for veterinary medicines
- guidance on appeals against regulatory decisions
- guidance on enforcement
- pharmacovigilance. Guidance on adverse events
- exemption scheme for small pet animals
- guidance on the use of the cascade
- record-keeping requirements for veterinary medicinal products
- manufacturing authorisations
- horse medicines (incorporating guidance relating to horse passports)
- medicated feeding stuffs and feed additives
- release of veterinary medicinal products to the UK market
- export certificates scheme
- controlled drugs
Animal Medicines Training Regulatory Authority (AMTRA)
AMTRA is an independent regulatory body whose task it is to ensure that the prescription and supply of VPS animal medicines in the UK is undertaken in a responsible manner by AMTRA-qualified persons.
Under the Regulations, AMTRA is the body appointed by the Secretary of State to keep a register of Suitably Qualified Persons (SQPs).
An SQP is an animal medicine advisor, known by the legally defined term "Suitably Qualified Person".
An SQP must pass a set of exams to demonstrate animal health knowledge and an understanding of the legal system, and be registered with AMTRA.
Once qualified, SQPs are allowed to prescribe and/or supply certain medicines (those classified POM-VPS and NFA-VPS) for farm animals, horses, and pets.
To become an SQP an individual must first enrol with AMTRA and pass the relevant examination.
Accredited internet retailer scheme
The VMD is inviting UK internet retailers of veterinary medicinal products to apply to be considered for accreditation under the VMD's 'accredited internet retailer scheme'.
Retailers who meet the accreditation criteria will be able to display a special logo on their website: the VMD's Internet Retailer logo.
This logo will include the retailer's unique accreditation number. Clicking on the number will take you to the retailer's entry in the register of accredited retailers on the VMD's website, allowing potential customers of the internet retailer to check the accreditation status.
There will also be a link to further information about the scheme.
The VMD's Accredited Internet Retailer Scheme is a means of facilitating self-regulation by UK-based internet retailers supplying veterinary medicines.
Following accreditation, on-site inspections of accredited internet retailers' premises (if they have not been inspected already) will be carried out, to check ongoing compliance with the Veterinary Medicines Regulations.
It is strongly advised that potential applicants read the scheme's criteria and application form documents carefully to ensure they complete the application form correctly and set out how, in their view, they meet the VMD's accreditation criteria.
This will avoid any problems or delays in our consideration of applications.
Any queries regarding applications for accreditation should be raised with the VMD Inspections Administration Team on 01932 338475.
Any queries regarding internet pharmacies in Northern Ireland should be referred to the Pharmaceutical Society Northern Ireland on 028 9032 6927.
Inspections and Investigations Team (IIT)
The Inspections & Investigations Team (IIT), formerly known as the Animal Medicines Inspectorate (AMI), is a team within the VMD's Post Authorisation Surveillance Unit, in the Operations Division.
The IIT is responsible for:
- the inspection of all registered veterinary practice premises (VPPs) in the UK from where veterinary surgeons retail supply veterinary medicinal products (VMPs), other than those registered with the Royal College of Veterinary Surgeons (RCVS) as Practice Standards Scheme premises. Practice Standard Scheme premises are inspected by the RCVS's inspectors under an agreement with the VMD but responsibility for enforcement of the Veterinary Medicines Regulations at those premises remains with the VMD
- the approval and inspection of premises in Great Britain from which Suitably Qualified Persons (SQPs) retail supply VMPs, and the approval and inspection of such premises in Northern Ireland on behalf of the Department of Health, Social Services and Public Safety (DHSSPS). SQPs are animal health care professionals who have undertaken appropriate training and examination in veterinary medicines and are registered with a body recognised by the VMD. SQPs are permitted to supply certain VMPs classified as POM-VPS and NFA-VPS, depending on the qualification they hold
- the approval and inspection of manufacturers and distributors of specified feed additives (SFAs), premixtures and feedingstuffs containing SFAs, and manufacturers and distributors of premixtures and feedingstuffs containing VMPs (collectively referred to as Schedule 5 products) in Great Britain. The Department of Agriculture and Rural Development (DARD) carry out similar inspections in Northern Ireland. Premises approved and inspected include commercial animal feed mills and on-farm mixers (including fish farmers)
Powers, notices and enforcement
Inspectors appointed under the Regulations have a number of powers under the Regulations.
These powers permit the inspector, on producing a duly authenticated authorisation if required, to enter any premises at a reasonable hour for the purpose of ensuring that the Regulations are being complied with.
Appointed inspectors have powers to seize unauthorised and authorised veterinary medicinal products that may have been illegally imported, supplied, marketed or administered.
A seizure notice may be served which sets out the details of which products have been seized and the grounds for seizure.
Appointed inspectors have powers to serve improvement notices on any person they believe is not complying with the legislation.
The notice will set out how the person is failing to comply with the Regulations, the exact nature of the failure, the measures that need to be taken to comply and how quickly they should be taken.
The VMD Guidance Note 10 - Guidance on Enforcement sets out guidance relating to the powers of inspectors, notices and enforcement action.
Offences under the Veterinary Medicines Regulations
There are a number of offences under the Regulations and these may be grouped by activity:
- sale, supply and putting on the market
- duties on authorised holders
- Full text of the Regulations