Finding information about a medicine Flashcards
Name an example of a place where you can find out information about medicines.
MHRA.
Name the 3 places where you can find out general information.
Summary of product characteristics.
British National Formulary.
British National Formulary for Children.
What is the summary of product characteristics?
A document used to be approved as part of the marketing authorisation.
‘How to use a medication // what the medication should be used to treat?’
Name the place where you can find patient information.
Patient Information Leaflet.
Name the 2 places where you can find out specialised information.
UK Teratology Information Service
UK Drugs in Lactation Advisory Service
What does licensing a medicine entail?
Researching the medicine in the lab and testing it in clinical trials.
Proves the drug works for the illness.
What is the Medicines Act (1968)?
Regulates the licensing // supply // administration of medicines.
What country does EMA originate from?
Europe
What country does FDA originate from?
America
What is marketing authorisation?
Processing // Receiving // Assessing evidence in order to support a medicinal product.
What is a dossier?
This is a collection of papers containing information about safety // manufacturing // toxicity.
What are the 3 stages for EU marketing authorisation?
Pre - Submission
Dossier Submission
Assessment
What does the pre - submission stage involve?
Requesting for eligibility
What does the dossier submission stage involve?
Product name // product information
Quality of drug
Risk management plan
What does the assessment stage involve?
Of dossier
Inspection of manufacturing site
