medicine regulations Flashcards
What is the MHRA?
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.
What is a medicinal product?
- NOT medicines (HMR2012)
- 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.
- Human blood is expressly excluded
What does the HMR say about marketing authorisations for human medicines?
- 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 to do in case of an off labelling 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 does the HMR say about the revocation, variation or suspension?
- Harmful or ineffective
- Incorrect information
- Breach of licence
- Unfulfilled licence
- Information not provided
- No longer EU based
- Non-compliance with Good Manufacturing Practice (GMP)
- Unfulfilled licence (non-UK)
- Public at risk
- Apply for change
- Poor manufacturing
What is an orphan drug?
*used to treat conditions that occur infrequently
What is an example of an orphan drug?
Ibuprofen is an orphan drug when used to treat the rare disease patent ductus arteriosus in neonates
How does a patient qualify for orphan medicine?
- for a disease that is life-threatening or chronically debilitating
- not more than 5 in 10,000
- no satisfactory method exists
What is a benefit that orphan medicinal products will have?
- Orphan medicinal products will benefit from up to 10 years of market
exclusivity from similar products
What are generics?
- Have the same composition as a Reference Medicinal Products
(RMPs) - Has the same pharmaceutical form
- Appropriate bioavailability studies (demonstrated bioequivalence)
- Typically, cheaper than branded medicines
What are branded generics?
- Generics that have a brand name.
- Encourage medical practitioners to prescribe branded generics which
have a lower price than non-branded generics
What is an abridged procedure/ what it entails?
- Manufacturers will have incurred the considerable cost of years of
R&D - A competitor can rely on the data for the original product only after
the passage of a data exclusivity period. - The data exclusivity period is eight years for products that have been
authorised in the UK.
What is the (EAMS) Early access to medicines scheme?
- Enables patients to have access to medicines which have not yet been
authorised - life-threatening or seriously debilitating conditions,
- no suitable alternative
- Voluntary
What does pharmacovigilance entail?
- Detection, assessment, understanding and prevention of adverse
effects or any other drug-related problem. - Promote the safe and effective use of drugs by providing reliable
information - Information obtainable before a medicine is placed on the market is
ultimately limited - Both the licensing authority and holders of manufacturing
authorisations must operate a pharmacovigilance system - Capture and evaluate all information
- Take all appropriate measures to minimise and prevent risk,
What is the yellow card scheme?
- MHRA
- Collecting and monitoring information on suspected safety concerns
or incidents involving medicines and medical devices. - Voluntary reporting
- Early warning that the safety of a product may require further
investigation.
