Regulation of Veterinary Medicinal Products

Which government agency is the Veterinary Medicines Directorate part of?

What is the legislative function of the VMD?

What is the inspection function of the VMD?

What is the authorisation function of the VMD?

What is the function of the VMD once a product has been authorised?

Which laws regulate veterinary medicinal products?

How have the laws surrounding veterinary medicinal products been consolidated?

What is the difference between an EU directive and a regulation?

What is the UK specific interpretation of the EU directive for veterinary medicinal products?

What is the legal definition of a veterinary medicinal product?

Which steps occur before data on a product is submitted to the VMD?

Which 3 steps are carried out by the VMD once data has been submitted for a product?

What is the role of vets in post authorisation surveillance?

Why is the process of developing a new veterinary medicinal product risky?

What is the term for the data submitted to the VMD on a veterinary medicinal product?

Which 3 parts is the data submitted to the VMD divided into?

What damaging effect do many veterinary medicinal products have on the environment?

What advice do the VMD provide regarding resistance to a product?

What is a product granted when it is approved by the VMD?

How does the procedure for authorising a product vary depending on whether the manufacturer is national or international?

What does SPC stand for?

What is an SPC?

What is an SPC specific to?

How is an SPC presented?

Give 3 reasons why an SPC may be updated

What is the first choice of drug to use for an animal under the cascade?

What is the risk when using a drug not licensed for the species to which it is administered?

What is the legislation for prescribing under the cascade?

What is 'off-label' use?

Which products may be chosen if there are no veterinary medicinal products available for 'off-label' use?

Are veterinarians able to make up medicines?

Give the prioritised steps for choosing a medicine under the prescribing cascade

What is the problem with using products licensed for human use?

What is a POM-V medicine?

What is a POM-VPS medicine?

Medicines for which species are often classified as POM-VPS?

What is a NFA-VPS medicine?

Give an example of an NFA-VPS product

What is an AVM-GSL medicine?

What is a schedule 6 exemption product?

In which species can schedule 6 exemption products not be used?

How does a person become an SQP?

Which qualification must veterinary nurses take to become a suitably qualified person to give prescriptions?

Which 2 classes of product can be sold by other products?

Are prescription diets regulated by the VMD?

Clients on holiday bring in an aggressive dog that has not been seen at the practice before, requiring phenobarbital which they have left at home. Can the vet dispense?

Are vets allowed to split a packet of medication?

Why is it important only to prescribe the amount of phenobarbital an animal requires?

When does a premise require licensing for prescribing medicines?

Does a vet's car count as a premise that requires licensing?

Which body holds the register of licensed premises?

To which body is the registration fee for licensing premises paid?

Where is the inspection fee for licensed premises paid?

Are SQPs allowed to split a pack of medication?

Which 4 conditions must be satisfied in order for veterinary medicines to be sold online?

How has the VMD helped people buy veterinary medicines online safely?

Is the VMD online retailer scheme voluntary or compulsory?

When prescribing for backyard chickens, are they classed as food producing animals?

Which products should be selected for backyard chickens?

How is the prescribing cascade different for food producing animals?

Which veterinary medicinal products cannot be used in food producing animals?

What is the minimum withdrawal period for eggs and milk when prescribing under the cascade?

What is the minimum withdrawal period for meat from poultry and mammals when prescribing under the cascade?

What is the minimum withdrawal period for meat from fish when prescribing under the cascade?

What is the term for the minimum withdrawal periods provided by the EU for prescribing under the cascade?

What records should be kept when prescribing under the cascade?

Who can prescribe under the cascade?

Why is it important to see a horse's passport before prescribing phenylbutazone?

Are horses food producing species?

Is signing a horse out of the food chain reversible or irreversible?

How should a horse be treated if the passport is not available?

Which drugs can be used to treat food producting horses under the cascade?

What minimum statutory withdrawal period needs to be observed in horses when prescribing under the cascade?

Where are medicines used in food producing horses recorded?

What should the vet do if it is necessary in an emergency to prescribe a medicine not allowed for food producing horses?

Where should adverse events be recorded?

If an adverse event is listed in possible side effects for a product, should the event be reported?

Does lack of efficacy count as an adverse event?

Which products are tested for residues by the VMD?

Should adverse events be reported when prescribing under the cascade?

Give 3 examples of adverse events in microchips that should be recorded

What are Animal Test Certificates?

Which clinical field trials require an Animal Test Certificate?

Are Animal Test Certificates required for nutraceuticals?

Are Animal Test Certificates required for non-medical therapies such as surgical interventions?

Are Animal Test Certificates required if the product is used in accordance with the SPC (summary of product characteristics) or cascade?