Medication Liscening (4A) Flashcards
What must a person or body have in order to sell or supply a medincal product?
Marketing Authorisation
What does MHRA stand for and what is their role?
Medicines and Healthcare products Regulatory Agency
- enforce standards of safety, quality and efficacy
- educate public and HCP
- research and development
Who applies for MAs and who evaluates MAs?
- companies who want sell or supply certain products
- MHRA reviews application and evaluates risk vs benefit
What can the holder of an MA do?
sell, supply and export product
What is an SPC?
Summary of Product Characteristics
- features and characteristics of the drug
- info for safe and effective use
- more info eg. shelf-life, overdose info
What is an ML?
Manufacturing License
- required to manufacture drugs
- must comply with GMP
- MHRA inspect premesis before ML and regularly to ensure high standards
What are the phases of clinical trials and what do they consist of?
Phase I - product is tested on a small group of healthy adults (50) (safety)
Phase II - product is tested on a larger group (500) some affected by disease (effectiveness) (placebo)
Phase III - larger group (up to thousands), against other treatment, over longer period
Phase IV - over longer periods, in combination with different people
What is the Yellow card scheme?
- any member of public can report any problems with medicines
- any adverse drug reactions
What is the Black Triangle Scheme?
- monitored more closely
- doesnt mean medicine is unsafe
- black triangles can be removed and reinstated
What are the classes of medicines recall and what do they mean?
Class 1 - removed from supply immediately (fatal)
Class 2 - removed within 48 hours (not fatal)
Class 3 - removed within 5 days (not fatal)
Class 4 - alert to caution HCP, no threat to patient (continued use, in caution)
