VMD: The Regulation of Veterinary Medicinal Products and Prescribing Responsibilities

What is the VMD responsible for?

regulation of veterinary medicinal products (VMPs)

What is the aim of the VMD?

protect human health, animal health, and the environment by assuring the quality, safety and efficacy of VMPs

VMP

veterinary medicinal products

What work is done at the VMD?

• inspection of registered UK premises involved with manufacture, distribution & supply of veterinary medicines

• post-authorisation monitoring

• enforcement of authorised and unauthorised prescription & use of veterinary medicines in the UK

• oversee legislation, regulations & policy relating to UK veterinary medicines

• assessment of UK marketing authorisation (MA) and clinical trial (ATC) application

• UK animal health policy lead on antimicrobial resistance

What are the benefits of regulation of veterinary medicines for the veterinary professional?

• assurance of quality

• assurance of safety

• assurance of efficacy

• veterinary specific and reliable info

• advice to ensure veterinary medicines are used in a way which will not pose a risk to humans, animals or environment

How is regulation achieved?

legislation

What legislations are related to the regulation of VMPs?

• The Veterinary Medicines Regulations (VMR) 2013

• The Veterinary Medicines (Amendment etc.) Regulations 2024

What do The Veterinary Medicines Regulations (VMR) 2013 and The
Veterinary Medicines (Amendment etc.) Regulations 2024 cover?

• definition of VMP

• data requirements for marketing authorisation (MA) application

• controls on production, marketing, prescription, distribution, PhV and use of VMPs

PhV

Pharmacovigilance

What’s the legal definition of a VMP?

• any substance/combination of substances presented as having properties for treating/preventing disease in animals

  • Any substance or combination of substances that may be
    used in, or administered to, animals with a view either to
    restoring, correcting or modifying physiological functions
    by exerting a pharmacological, immunological or
    metabolic action, or by making a medical diagnosis,

• Any substance or combination of substances that may be
  used for the purpose of euthanising an animal

A product may be a VMP if it is medicinal by …

presentation or function

When can VMDs be placed on the market?

• When authorised by the VMD

• has marketing authorisation

What are the 4 parts of the electronic dossiers that are submitted to the VMD?

1. administrative

2. quality

3. safety

4. efficacy

How can there by harmonisation of the regulatory approach of VMPs across territories?

• legislation

• harmonised scientific and regulatory guidance

What is it called when each discipline assesses the data package to identify each product’s benefits and risks?

benefit-risk assessment

What are the UK distribution categories?

prescription only

• POM-V

• POM-VPS

non-prescription

• NFA-VPS

• AVM-GSL

Are prescription diets regulated by the food standard agency or the VMD?

Food Standards Agency (FSA)

POM-V

prescription only medicine - veterinarian

POM-VPS

prescription only medicine - veterinarian, pharmacist, SQP

NFA-VPS

non-food animal - veterinarian, pharmacist, SQP

AVM-GSL

authorised veterinary medicine - general sales list

SPC

summary of product characteristics

What is the Summary of Product Characteristics (SPC)?

• legal document

• contain info derived from original assessment of VMP when first authorised

• updated if changes made

What does the SPC contain?

info about medicine

• specific to use and indicated target species

• presented in standardised format

• updated when new indication of withdrawal periods are agreed

• also updated based on pharmacovigilance reports

Where is the SPC found?

Product Information Database (PID) on VMD website

When can you prescribe meds under the cascade?

when no suitable veterinary medicine authorised in your territory for a specific condition in the animal being treated, to avoid unacceptable suffering

What rules apply to prescribing drugs under the cascade?

• only vet surgeons registered with RCVS can prescribe under cascade

• must obtain owner’s consent

When products are used under the cascade have they been assessed by the VMD?

NO

When prescribing under the cascade, what does the vet take responsibility for ensuring?

• product safe and effective

• environmental impact considered

• consumer safety restrictions in place for food-producing species and they protect consumers

What factors can influence how the active substance of a drug behaves in an animal?

• excipient

• method of manufacture

other ingredients in a formulation

excipients

When deciding whether to use human medicines to treat animals, what kind of justification should be made?

clinical

What does the VMR 2013 require the prescriber to do, so they can prescribe under the cascade?

• carry out clinical assessment

• ensure animal is ‘under that veterinary surgeon’s care’

When must a physical exam be performed to prescribe medications?

• suspected notifiable disease

• prescribing controlled drugs

• prescribing antibiotic/antifungal/antiviral

• prescribing antiparasitic

What laws/professional guidance relate to controlled drugs?

• The Misuse of Drugs Regulations 2001

• The VMR 2013

• The RCVS Controlled Drugs Guidance

Schedule 1 drugs

non-medicinal drugs (e.g. cannabis and derivatives not listed in schedule 2)

Schedule 2 drugs

• opiates

• morphine

• methadone

• codeine

• fentanyl

• ketamine

• amphetamine

• cocaine

Schedule 3 drugs

• most barbiturate (including phenobarbital)

• buprenorphine

• gabapentin

• pregabalin

• midazolam

• tramadol

Schedule 4 drugs

• all other benzodiazepines (including diazepam)

• xylazine

• anabolic and androgenic steroids

Schedule 5 drugs

special restrictions / exemptions apply to certain low strength non-injectable preparations of codeine and very low-strength morphine

How long are written prescriptions for controlled drugs valid?

max 28 days (schedule 2,3 & 4)

Are vets allowed to write repeat prescriptions for controlled drugs in schedule 2 or 3?

NO

What should you always consider when prescribing controlled drugs?

• normally only prescribe up to 30 days worth of CD meds in one go

• risks

• be sure owner competent to use meds safely

For what schedule of controlled drug are vets allowed to write repeat prescriptions?

schedule 4 and 5

How long are written prescriptions for schedule 5 controlled drugs valid for?

up to 6 months

suspected adverse event

any observation in animals or humans, whether or not considered to be product related, which is unfavourable or unintended and which occurs after the use of, or exposure to, a veterinary medicinal product

When should you report a suspected adverse event?

• Authorised use causing an adverse event in a treated animal or human (even if already stated in SPC).

• Unauthorised/cascade (“off-license”/“off-
  label”) use causing an adverse event.

• Report even if there are complicating
  factors, or you are not 100% certain the
  event was caused by the product

Who is responsible for reporting suspected adverse events?

• MAHs

• regulators

• vets, vet nurses, pharmacists, SQPs (under professional code of conduct not legally required)

MAH

marketing authorisation holders

What are the outcomes of pharmacovigilance?

• new benefit-risk assessment

• changes to warnings on labelling

• recall of a defective batch

• change to distribution category

• suspension of marketing authorisation to resolve issue

• withdrawal of marketing authorisation in extreme cases

What are your main responsibilities as a vet regarding VMPs?

• Use authorised medicines responsibly in the interests of animal welfare (appropriate dose, quantity prescribed, correct indication, etc.)

• Ensure contra-indications and warnings are understood, especially withdrawal periods

• Keep complete records of use

• Report suspected adverse events (including suspected lack of efficacy)

• Follow RCVS Code of Professional Conduct

• Report illegal use and suspected counterfeit medicines to the VMD