Lecture 4 - medication licensing Flashcards
What is assembling a drug
Encapsulated the drug in a container and labelling it before selling it. To just simply labelling it.
What is a WDAH
Wholesale distribution authorisation. The ability to manufacture, assemble and import medicines on a large scale
What does a company need in order to have a WHA
Must comply with GMP, meaning the medicines must:
- be of a consistent high quality
- be appropriate for their intended use
- meet requirements of the MA¢
How often does the MHRA inspect the ML premises
Initally and regular intervals
Is a qualified person needed in a ML application
Yes and theirs and a production managers qualifications need to be stated
What does a WDA stand for
Wholesale dealers license which is issued by the MHRA
What does a WDA do
A license that allows manufactures to:
- sell and offer to sell GSL, P, POM and herbal remedies on a large scale to anyone other than the patient.
- import unlicensed meds from the EEA
- export medicinal products to the EEA
What information must a WDA state
- the premises in which operations occur in
- the steps that are carried out when there is a faulty product and a recall is required
- responsible person
What does the MHRA consider when looking at ML and WDA applications
- The operations to be carried out
- The premises it will occur in
- the equipment available to carry out the actions
- the qualifications of the person supervising operations
- the arrangements made to ensure safe keeping, maintenance and record keeping of the products made and assembled
What is an IMP
Investigation medicinal product, a product that is involved in the investigation as a part of an undergoing clinical trials or trials of some sort. E.g. the medicine being trialed and a placebo which is used as a reference.
What is a non-IMP
Medication given to a patient in a trial that isn’t a part of a trial e.g. asthmatic requiring the use of an inhaler during a clinical trial
Who reviews the CTIMPs
CTIMPS = clinical trial IMPS
The MHRA review all the research ethics committee
How many phases are in a clinical trial
3
What happens id stage one of the clinical trial
A small group of roughly 50 young healthy people are used to test the dosage, safety and side effects of the medicine.
What happens in stage of 2 of clinical trial
- Large number of people are used, around 500.
- ## Using people with the disease and its tested against a a placebo
What happens in stage 3 of clinical trials
Much wider population of people withe the disease is used across many different countries.
- efficacy is tested over longer periods and against other existing forms of treatment ¢
What is phase 4
Tests over longer periods of time with different groups of people in conjunction with other treatments
What is pharmacovigilance
The responsibility between MHRA and the MA to Capture and evaluate risks regarding a new drug and put measures in place to reduce and minimalist risk.
What is the yellow card system
A system in which anyone in the public can report any type of side effects related to a medicine
What is the downsides of yellow card
Unreliable because of the info being voluntary and thus may not be accurate or provide adequate information
When does info need to be reported the yellow card
In children
In people over 65
Associated with drug interactions or delayed effects
What is the back triangle scheme
New medicines and vaccines are denoted with a black triangle and it states the adverse side effects
How often are black triangle medications reviewed
Roughly every 5 years
Can a black triangle be reinstated once removed
Yes
If a medicine is found to be safe once distributed what happens
It is recalled
How many levels of medicine recalls are there
5
- 1) risk of death or disability and its is alerted on the MHRA website and immediate action is to be take
2) can cause defects and is life threatening, action must be taken within 48 hours
3) med is unlikely to cause harm however is recalled for other reasons such an non compliance with MHRA
4) No threat to patient however either defect reducing efficacy or defects ion packaging however a recall is unsuitable so cautioned continued use is needed
5) the manufacturer can identify the affected customers and thus is able to contact them directly thus no healthcare system alert is needed
