Medicine Regulation - Political And Legal Frameworks I Flashcards
What are medicinal products (NOT medicines)
For preventing or treating disease in human beings
Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic
action
Making a medical diagnosis.
Does blood count as a medicinal product?
No
Modern medicines legislation in the UK was triggered by which tragedy?
Thaolidomide
Who are the regulators fro medicines and licensing?
Medicines and Healthcare products Regulatory Agency (MHRA)
an executive agency of the Department of Health and Social Care
The MHRA is also enforcement authority for licensing matters in the UK.
Marketing authorisations for human medicines
Human Medicines Regulations 2012
A person may not sell or supply or offer to sell or supply a medicinal product unless that product has a UK marketing authorisation
Summary of Product Characteristics (SmPC)
What is off-label prescribing?
Treating a patient who has a condition for which the product does not have a marketing authorisation
A marketing authorisation can be given to treat one condition but not another condition for which it may nevertheless be effective
What is an example of off-label prescription?
Medicine for migraines
Medicine for period pains
THEY must be covered by the authorisation and licensed appropriately
Revocation, variation or suspension
LIST at least 5 points:
A. Harmful or ineffective
B. Incorrect information
C. Breach of licence
D. Unfulfilled licence
E. Information not provided
F. No longer EU based
G. Non-compliance with Good Manufacturing
Practice (GMP)
H. Unfulfilled licence (non-UK)
I. Public at risk
J. Apply for change
K. Poor manufacturing
E. No longer EU based, affect of Brexit?
It may cause shortages in products which are not from the EU, and therefore have not been stockpiled by suppliers
J. Apply for change, by authorities
If there is any additional info to be added
Orphan drugs
Used to treat conditions that occur infrequently
Cost of R&D would not be recovered by the expected sales
Therefore;
the pharmaceutical industry would be unwilling to develop the medicinal product under normal market conditions.
To qualify for orphan designation:
for a disease that is life-threatening or chronically debilitating not more than 5 in 10,000 no satisfactory method exists
What are generics?
Have the same composition as a Reference Medicinal Products (RMPs)
Has the same pharmaceutical form
Appropriate bioavailability studies (demonstrated bioequivalence)
Generic products are usually _______ that branded medicines.
cheaper
Is there guaranteed safety with generic products?
yes, same formula