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VN04 > Legal requirements applicable to veterinary medicines > Flashcards

Legal requirements applicable to veterinary medicines Flashcards

1
Q

what is a veterinary medicinal product?

A

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

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2
Q

what is DEFRA responsible for?

A
  • wildlife and pet legislation
  • animal welfare act
  • livestock strategies
  • animal transport
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3
Q

what does the VMD assure?

A

assures the safety, quality, and efficacy of veterinary medicines

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4
Q

what is the VMD responsible for?

A

the categorisation and supply of veterinary drugs in the UK

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5
Q

what does MAVIS stand for?

A

the marketing authorisations veterinary information service

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6
Q

what does MAVIS do?

A

provide you with the best available information on the work of the VMD

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7
Q

what does SARRS stand for?

A

Th suspected adverse reactions surveillance scheme

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8
Q

what is SARRS?

A

a voluntary scheme for monitoring reports of suspected adverse reactions

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9
Q

what is The Medicines Act 1968?

A

governs the manufacture, storage, handling and dispensing of medicines, both veterinary and human

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10
Q

what is The Veterinary Medicines Regulations 2013?

A

details the manufacture, marketing, distribution, authorisation and import of medicines

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11
Q

what is The Veterinary Medicines Regulations?

A

sets out the distribution. categories for UK drugs

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12
Q

what is the summary of product characteristics?

A

a description of a medicinal product’s properties and the conditions attached to its use

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13
Q

what is the withdrawal period?

A

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

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14
Q

POM-V
a product will be categorised as this when it:

A
  • 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
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15
Q

POM-VPS
a product will be categorised as this when:

A
  • 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
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16
Q

NFA-VPS
a product will be categorised as this when:

A
  • 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
17
Q

AVM-GSL
a product will be categorised in this when:

A
  • 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
18
Q

what does AVM-GSL stand for?

A

authorised veterinary medicine - general sales list

19
Q

what are SAES?

A
  • 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
20
Q

what are controlled drugs?

A
  • drugs with the potential for abuse
  • divided into 5 categories
21
Q

what is the Misuse of drugs act 1971?

A
  • criminal
  • three classes, ABC
  • major act controlling drugs
  • list of prohibited drugs and of the penalties linked to their possession and supply
22
Q

what is the misuse of drugs regulations 2007?

A
  • medicinal
  • 5 schedules
  • primary concerned with all dangerous drugs
23
Q

what are some characteristics of schedule 1 drugs?

A
  • heroin, LSD, cocaine
  • high potential for abuse
  • no therapeutic use
24
Q

what are some characteristics of schedule 2 drugs?

A
  • methadone, fentanyl, ketamine
  • high potential for abuse
  • therapeutic value
  • special requirements
25
Q

what must a requisition have?

A
  • signed by the vet
  • state name, address, professional qualifications, RCVS number
  • state the purpose to which it is to be used
26
Q

what are some characteristics of schedule 3 drugs?

A
  • buprenorphine, tramadol, phenobarbitol
  • lower abuse risk
27
Q

what are some characteristics of schedule 4 drugs?

A

two main classes
- benzodiazepines
- anabolic steriods

28
Q

what is the cascade system?

A
  • outlines the order that medications should be selected from
  • important specific exceptions outlined in the cascade. - off-label use
29
Q

what are some characteristics of schedule 5 drugs?

A
  • kaolin, morphine and pardale v
  • lower risk of abuse
30
Q

what is the withdrawal periods for eggs/milk and meat?

A

7 days - eggs/milk
28 days - meat

VN04 (13 decks)

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