L35: Pharmaceuticals development and testing Flashcards Preview

VPH > L35: Pharmaceuticals development and testing > Flashcards

Flashcards in L35: Pharmaceuticals development and testing Deck (23)
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1
Q

Who is VMD an agency of?

A

Defra

2
Q

What must be true for a drug to be authorised?

A

Favourable risk-benefit balance

3
Q

Which countries are MAs valid in?

A

Some UK, some multiple member states

4
Q

What is in a Summary of Product Characteristics?

A

Legal document, like data sheet but includes pharmacology

5
Q

Who is the Summary available to?

A

Public

6
Q

What are table 1 drugs?

A

Allowed in food animals in the EU

7
Q

What are table 2 drugs?

A

Completely prohibited in food animals

8
Q

What is minimum withdrawal for eggs and milk?

A

7 days

9
Q

What is minimum withdrawal for poultry and mammals?

A

28 days

10
Q

What is minimum withdrawal for fish?

A

500 degree days

11
Q

What happens if a minor breach of residue?

A

Advice

12
Q

What happens if a major breach of residue?

A

Prosecution

13
Q

Who are the only people who can prescribe under cascade?

A

MRCVS

14
Q

Does VMD regulate prescription diets?

A

No

15
Q

What must you do for internet/postal supply to be allowed?

A

Advice on safe administration, make sure the person is competent

16
Q

How many days of a controlled drug are you allowed to give?

A

28

17
Q

What happens if lots of adverse reactions from VPS?

A

POM-V

18
Q

What must SQPs supply VMPs with?

A

Authorised packaging and leaflet

19
Q

What happens if passport is lost?

A

Automatically not for human consumption

20
Q

What happens if given an emergency medication which is not suitable for human consumption?

A

Must sign out of food chain

21
Q

Who do you report adverse events to?

A

VMD or MA holder

22
Q

Who do you report human products to?

A

VMD not MA

23
Q

What is an example of an adverse effect?

A

Lack of efficacy

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