Legal requirements applicable to veterinary medicines Flashcards
what is a veterinary medicinal product?
any substance or combination of substances presented as having properties for treating or preventing disease in animals
what is DEFRA responsible for?
- wildlife and pet legislation
- animal welfare act
- livestock strategies
- animal transport
what does the VMD assure?
assures the safety, quality, and efficacy of veterinary medicines
what is the VMD responsible for?
the categorisation and supply of veterinary drugs in the UK
what does MAVIS stand for?
the marketing authorisations veterinary information service
what does MAVIS do?
provide you with the best available information on the work of the VMD
what does SARRS stand for?
Th suspected adverse reactions surveillance scheme
what is SARRS?
a voluntary scheme for monitoring reports of suspected adverse reactions
what is The Medicines Act 1968?
governs the manufacture, storage, handling and dispensing of medicines, both veterinary and human
what is The Veterinary Medicines Regulations 2013?
details the manufacture, marketing, distribution, authorisation and import of medicines
what is The Veterinary Medicines Regulations?
sets out the distribution. categories for UK drugs
what is the summary of product characteristics?
a description of a medicinal product’s properties and the conditions attached to its use
what is the withdrawal period?
period of time after the administration of a drug to an animal during which food products from that animal may still contain unacceptably high levels of the drug
POM-V
a product will be categorised as this when it:
- contains a new active ingredient not previously used in a veterinary medicine in the UK
- requires the specialist knowledge of a vet for its safe use or application
- has a narrow safety margins requiring above average care in its use
POM-VPS
a product will be categorised as this when:
- they are used to prevent the effects of endemic disease in herds, flocks, or individual animals
- their use implies. a rise for the user, the animal, consumer safety or environment
- a professional can be given adequate training in its use
NFA-VPS
a product will be categorised as this when:
- it is indicated for use in non-food animals
- used routinely to prevent or limit the effects of endemic disease in non-food animals
- risks to user, animal, environment
AVM-GSL
a product will be categorised in this when:
- it has a wide margin of safety
- used to alleviate, prevent the symptoms or support the treatment of common ailments
- special advice is not necessary to permit safe and effective use
- can be supplied by any retailer
what does AVM-GSL stand for?
authorised veterinary medicine - general sales list
what are SAES?
- non official term
- medicines marketed in accordances with the small animal exemption scheme
- medicines for use in certain pet species where the active ingredient of which has been declared by the. secretary of state as not requiring veterinary control
what are controlled drugs?
- drugs with the potential for abuse
- divided into 5 categories
what is the Misuse of drugs act 1971?
- criminal
- three classes, ABC
- major act controlling drugs
- list of prohibited drugs and of the penalties linked to their possession and supply
what is the misuse of drugs regulations 2007?
- medicinal
- 5 schedules
- primary concerned with all dangerous drugs
what are some characteristics of schedule 1 drugs?
- heroin, LSD, cocaine
- high potential for abuse
- no therapeutic use
what are some characteristics of schedule 2 drugs?
- methadone, fentanyl, ketamine
- high potential for abuse
- therapeutic value
- special requirements
what must a requisition have?
- signed by the vet
- state name, address, professional qualifications, RCVS number
- state the purpose to which it is to be used
what are some characteristics of schedule 3 drugs?
- buprenorphine, tramadol, phenobarbitol
- lower abuse risk
what are some characteristics of schedule 4 drugs?
two main classes
- benzodiazepines
- anabolic steriods
what is the cascade system?
- outlines the order that medications should be selected from
- important specific exceptions outlined in the cascade. - off-label use
what are some characteristics of schedule 5 drugs?
- kaolin, morphine and pardale v
- lower risk of abuse
what is the withdrawal periods for eggs/milk and meat?
7 days - eggs/milk
28 days - meat
