Wk 25 - Medicines regulation Flashcards
True or false: The term medicine is not defined in the human medicines regulation 2012
True
True or false: A condom is a medicinal product
False - device
True or false: All shampoos are cosmetic and are therefore exempt from the HMR 2012
False
True or false: A salbutamol MDI is classified as a medical device
False - product
True or false: Packaging for medical devices should be marked with the letter ‘EC’
False - CE or UKCA
True or false: Folic acid tabs 400mcg can be licensed as a medicinal product
True
True or false: Liquid nitrogen can be classified as a medicinal product
True
True or false: Emulsifying ointment BP contains no active ingredient and is therefore not a medicinal product
False
True or false: A tinzaparin pre-filled syringe is classified as a medicinal product
True
True or false: It is possible for eye drops + nasal drops to be classified as medical devices
True
When is glucosamine products licensed as a medicine?
Containing > 1178mg/day of glucosamine base
Below = food supplement
What are the types of medical devices?
- Active implantable medical device (pacemaker, catheter)
- General medical device (bandages, contacts)
- In vitro diagnostic medical device (pregnancy test, bp machine)
What is the hierarchy of medicine regulation?
- Government health ministers
–> CHM
–> MHRA + BP commission
Define medicinal product
Substance that has properties of preventing/treating disease in humans
What is exempted from medicines legalisation?
Food + cosmetics
