Regulation of medicines Flashcards
What is the definition of a medicinal product?
Any substance or combination of substances presented as having properties of preventing or treating disease in humans or may be administered with a view to correcting or modifying pharmacological function
What is meant by an authorised medicinal product?
One that has:
a) marketing authorisation - meds
b) cert of registration - homeopathics
c) traditional herbal reg - herbal remedies
A borderline substance is one that contains a pharmacological active substance. True or false?
False - regarded as medicinal if it does.
A borderline substance is one that is not easy to distinguish from a medicine e.g. food supplement/cosmetics
Medical devices are covered by human medicines regulations 2012. True or false?
False - covered by Medical devices regs 2002
Sutures and dressings are regarded medical devices. True or false?
True
It is recommended that medical devices have CE mark on. True or false?
False - mandatory
CE mark is regarded equivalent to a marketing authorisation. True or false?
True
CE mark shows that the manufacturer claims the product is safe and fit for its intended purpose. True or false?
True
Phase 1 of clinical trials involves giving the drug to a large group of people. True or false?
False - giving to a small number of people for the first time
Phase 2 of clinical trials is to see if the drug is effective and to further evaluate its safety. True or false?
True
Phase 3 of clinical trials involves giving the drug to 1000-3000 people to confirm effectiveness. True or false?
True
Phase 4 of clinical trials involves pre-marketing studies. True or false?
False - post marketing studies
All relevant medicinal products must have MAs. True or false?
True
Products on the market prior to licensing requirements of the Medicines Act were granted a Product licence of right. True or false?
True
Biological and biotechnology products are a type of application for MA. True or false?
True
MAs are initially granted for a period of 3 years. True or false?
False - 5 years
MAs must be renewed on expiry, True or false?
True
MA holder must keep licencing authority updated on proposed changes in the product or procedures and fresh information affecting validity of data on which licence was granted. True or false?
True
The European Medicines Agency is the UK’s medicines licencing authority. True or false?
False - the MHRA is
MA holders are advised to keep records of any adverse reports, all sales/supplies, sources of all materials and produce a periodic safety update report. True or false?
False - they must keep records
MHRA doesn’t have the right to reject product names used in MA. True or false?
False - can reject any name if it considers that name will cause confusion, is misleading or is otherwise unsafe
There is a requirement for paediatric data based on a paediatric investigation plan (PIP). True or false?
True
For paeds, the category of MA is Paediatric Use Marketing Authorisation. True or false?
True
Buccolam (buccal midazolam) was the first ever children’s medicine to hold PUMA. True or false?
True
