L35: Pharmaceuticals development and testing Flashcards
Who is VMD an agency of?
Defra
What must be true for a drug to be authorised?
Favourable risk-benefit balance
Which countries are MAs valid in?
Some UK, some multiple member states
What is in a Summary of Product Characteristics?
Legal document, like data sheet but includes pharmacology
Who is the Summary available to?
Public
What are table 1 drugs?
Allowed in food animals in the EU
What are table 2 drugs?
Completely prohibited in food animals
What is minimum withdrawal for eggs and milk?
7 days
What is minimum withdrawal for poultry and mammals?
28 days
What is minimum withdrawal for fish?
500 degree days
What happens if a minor breach of residue?
Advice
What happens if a major breach of residue?
Prosecution
Who are the only people who can prescribe under cascade?
MRCVS
Does VMD regulate prescription diets?
No
What must you do for internet/postal supply to be allowed?
Advice on safe administration, make sure the person is competent
How many days of a controlled drug are you allowed to give?
28
What happens if lots of adverse reactions from VPS?
POM-V
What must SQPs supply VMPs with?
Authorised packaging and leaflet
What happens if passport is lost?
Automatically not for human consumption
What happens if given an emergency medication which is not suitable for human consumption?
Must sign out of food chain
Who do you report adverse events to?
VMD or MA holder
Who do you report human products to?
VMD not MA
What is an example of an adverse effect?
Lack of efficacy
