Medicinal Research W8 Flashcards
What does off-labeling prescription treat?
Treating a patient who has a condition for which the product does not have a marketing authorisation
Revocation, variation or suspension of marketing authorisation when…
Harmful or ineffective
Incorrect information
Breach of licence
Unfulfilled licence
No longer EU based
Non compliance with good manufacturing practice (GMP)
Unfulfilled licence (not uk)
Public at risk
Apply for a change
Poor manufacturing
When are orphan drugs used?
Used to treat conditions that occur infrequently
Cost of R and D would not be recovered by the expected sales
How do you qualify as an orphan drug?
For a disease that is life threatening or chronically debilitating
Not more than 5 in 10,000
No satisfaction method exists
What are the qualifications for branded drugs when comparing with generic drugs?
Have the same composition as References Medicinal Products
Has the same pharmaceutical form
Appropriate bioavailability studies
What are branded generics?
Generics that have a branded name
Encourage medical practitioners to prescribe branded generics which have a lower cost
What is the data exclusivity period ?
Period of eight years for products that have been authorised in the UK
What is early access to medicines scheme (EAMS)?
Enables patients to have access to medicines which have not yet been authorised.
What is pharmacovigilance?
Detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
Who must operate pharmacovigilance?
The licensing authority
Holders of manufacturing authorisation
What is the yellow card scheme?
MHRA collects and monitors information on suspected concerns or incidents involving medicines and medical devices.
Who is the regulatory body of the pharmacy profession?
GPhC
What is the structure of the GPhC?
Has a chair and 13 other members of the council appointed by the public appointments commission.
Seven members are registrants and seven are lay men.
Where does the GPhC have regulatory powers?
England, Scotland and Wales
Not Northern Ireland
What does the GPhC do?
Register
Standards for pharmacies
Fitness to practice
Standards for pharmacists
Education/ training
