Veterinary Medicines Directorate (VMD) and Reference File Download Link

About the Veterinary Medicines Directorate

The Veterinary Medicines Directorate (VMD) is the UK government's regulatory authority for veterinary medicines. Established in 1989, the VMD operates as an executive agency of the Department for Environment, Food and Rural Affairs (Defra). Its primary mission is to protect animal health, public health, and the environment by ensuring the safe, effective, and quality-assured use of veterinary medicines throughout the United Kingdom.

Located in New Haw, Addlestone, Surrey, the VMD employs approximately 200 staff members with diverse expertise including veterinarians, pharmacists, toxicologists, microbiologists, and administrative professionals. This multidisciplinary team allows the VMD to comprehensively address all aspects of veterinary medicine regulation from scientific assessment to enforcement.

The VMD's operation extends across Great Britain, while in Northern Ireland, functions are carried out by the Department of Agriculture, Environment and Rural Affairs (DAERA) in collaboration with the VMD. The agency works closely with veterinary professionals, pharmaceutical companies, farmers, pet owners, and other stakeholders to achieve its regulatory objectives while facilitating access to necessary veterinary medicines.

1989

Veterinary Medicines Directorate established as an executive agency

1992

Implementation of the Medicines Act 1968 regulations for veterinary medicines

2005

Implementation of Veterinary Medicines Regulations 2005

2013

Introduction of the VMD's Strategy 2013-2015

2019

Publication of the VMD's Strategic Plan 2019-2023

Responsibilities and Functions

The Veterinary Medicines Directorate carries out a wide range of responsibilities related to the regulation of veterinary medicines in the UK. These functions include:

Medicines Authorization

Assessing and granting marketing authorizations for veterinary medicines to ensure they meet safety, quality, and efficacy standards before they can be sold or used in the UK.

Pharmacovigilance

Monitoring the safety of authorized veterinary medicines through the collection and assessment of adverse event reports and taking regulatory action when necessary.

Inspection and Enforcement

Conducting inspections of manufacturing sites, distribution centers, and retail outlets to ensure compliance with regulations and taking enforcement action when breaches are identified.

Residues Monitoring

Managing the surveillance of veterinary medicine residues in food-producing animals to ensure food safety and compliance with maximum residue limits.

Licensing

Issuing licenses for manufacturers, wholesalers, and retailers of veterinary medicines, and ensuring they comply with good distribution and manufacturing practices.

Policy Development

Contributing to the development of policies and legislation related to veterinary medicines at both national and international levels.

European Collaborations

Before Brexit, the VMD worked extensively with the European Medicines Agency (EMA) and other European national competent authorities in the decentralized and mutual recognition procedures for veterinary medicine authorizations. Following the UK's departure from the EU, the VMD has developed its own independent authorization procedures while maintaining scientific collaboration with European and international regulatory bodies.

Regulatory Framework

The VMD operates within a comprehensive legal framework that governs the development, authorization, marketing, and use of veterinary medicines in the UK. The main pieces of legislation include:

The Veterinary Medicines Regulations 2013 (as amended) The primary legislation governing the regulation of veterinary medicines in the UK.
The Medicines Act 1968 Provides the foundation for pharmaceutical regulation in the UK.
The Feed Hygiene (England) Regulations 2010 Addresses medicated feedstuffs.
The Rabies (Importation of Dogs, Cats and Other Mammals) Order 1974 Pertains to rabies vaccination requirements.

Authorization Categories

Veterinary medicines in the UK receive different types of authorizations based on their nature, target species, and intended use:

Full Marketing Authorization Granted after a comprehensive assessment of quality, safety, and efficacy data.
Exceptional Marketing Authorization For products that would not otherwise receive authorization but are needed for particular animal health situations.
Temporary Authorizations for Emergency Use For emergency situations when no authorized product is available.
Small Animal Exemption Scheme Allows certain medicines for minor species (like rabbits and caged birds) to be marketed without a full marketing authorization.
Autogenous Vaccines Prepared specifically for a particular farm or animals from that farm.

Prescription Classification

Veterinary medicines are classified according to their distribution and availability:

POM-V Prescription only medicine, which can be prescribed by any veterinary surgeon.
POM-VPS Prescription only medicine, which can be prescribed by a vet, pharmacist, or suitably qualified person (SQP).
NFA-VPS Non-food animal medicine, which can be supplied by a vet, pharmacist, or SQP for non-food animals.
AVM-GSL Authorised veterinary medicine of general sales list, available without a prescription.

Services and Initiatives

The VMD provides various services to stakeholders and runs several initiatives to support its regulatory mission:

Marketing Authorization Service

Processes applications for marketing authorizations of veterinary medicines, providing guidance throughout the application process.

Veterinary Medicine Investigation Scheme

Collects and assesses reports of suspected adverse reactions to veterinary medicines, taking appropriate regulatory action when necessary.

VMD Publications Shop

Sells all authorized product information summaries (SPCS) and other VMD publications to stakeholders.

Residues Surveillance Scheme

Monitors veterinary medicine residues in food-producing animals to ensure food safety and compliance with maximum residue limits.

Antimicrobial Resistance Strategy

Addresses the challenge of antimicrobial resistance through targeted interventions and stewardship programs.

VMD Data Protection

Ensures protection of confidential commercial information submitted as part of authorization applications while maintaining transparency requirements.

Strategic Priorities

The VMD works towards several strategic priorities outlined in its current strategic plan:

Promoting the responsible use of veterinary medicines, particularly antimicrobials, to combat antimicrobial resistance
Ensuring continued availability of effective veterinary medicines for animal health and welfare
Maintaining high regulatory standards following Brexit while facilitating innovative product development
Enhancing stakeholder engagement and communication
Leveraging data and digital solutions to improve regulatory effectiveness and transparency
Strengthening international collaboration on veterinary medicine regulation

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