Licensed and unlicensed medicines Flashcards
What is the MHRA and what does it involve?
Stands for Medicines and healthcare products regulatory agency.
The MHRA is the UK regulator of medicines,
medical devices and blood components for
transfusion, responsible for ensuring their safety,
quality and effectiveness
Who authorises the licensing process of medicines???
The CHM (The Commission on Human Medicines)
The CHM will either recommend a licence be
granted, accept the application subject to
modifications, or reject the application with reasons
What does off-label mean???
When a licensed medicine is used for a certain condition, age group or does for which it has not been licensed.
What does unlicensed medicine mean???
Medicines produced without a MA (Marketing authorisation)
What is the difference between unlicensed and off-label medicine???
Unlicensed medicine is a medicine that does not have a UK MA.
Off-label medicine is a medicine with an existing UK MA.
What does specials mean???
A medicine manufactured by a specials manufacturer holding a
Manufacturer’s Specials License (MS) in multiple quantities with
end product analytical testing.
Why are specials so important???
Because it increases the use of specials instead of making products extemporaneously.
This ensures better quality in the manufacturing process and enhances patient safety.
