Lecture 4 - medication licensing

Question 1

What is assembling a drug

Answer 1

Encapsulated the drug in a container and labelling it before selling it. To just simply labelling it.

Question 2

What is a WDAH

Answer 2

Wholesale distribution authorisation. The ability to manufacture, assemble and import medicines on a large scale

Question 3

What does a company need in order to have a WHA

Answer 3

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¢

Question 4

How often does the MHRA inspect the ML premises

Answer 4

Initally and regular intervals

Question 5

Is a qualified person needed in a ML application

Answer 5

Yes and theirs and a production managers qualifications need to be stated

Question 6

What does a WDA stand for

Answer 6

Wholesale dealers license which is issued by the MHRA

Question 7

What does a WDA do

Answer 7

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

Question 8

What information must a WDA state

Answer 8

• 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

Question 9

What does the MHRA consider when looking at ML and WDA applications

Answer 9

• 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

Question 10

What is an IMP

Answer 10

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.

Question 11

What is a non-IMP

Answer 11

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

Question 12

Who reviews the CTIMPs

Answer 12

CTIMPS = clinical trial IMPS
The MHRA review all the research ethics committee

Question 13

How many phases are in a clinical trial

Answer 13

3

Question 14

What happens id stage one of the clinical trial

Answer 14

A small group of roughly 50 young healthy people are used to test the dosage, safety and side effects of the medicine.

Question 15

What happens in stage of 2 of clinical trial

Answer 15

• Large number of people are used, around 500.
• ## Using people with the disease and its tested against a a placebo

Question 16

What happens in stage 3 of clinical trials

Answer 16

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 ¢

Question 17

What is phase 4

Answer 17

Tests over longer periods of time with different groups of people in conjunction with other treatments

Question 18

What is pharmacovigilance

Answer 18

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.

Question 19

What is the yellow card system

Answer 19

A system in which anyone in the public can report any type of side effects related to a medicine

Question 20

What is the downsides of yellow card

Answer 20

Unreliable because of the info being voluntary and thus may not be accurate or provide adequate information

Question 21

When does info need to be reported the yellow card

Answer 21

In children
In people over 65
Associated with drug interactions or delayed effects

Question 22

What is the back triangle scheme

Answer 22

New medicines and vaccines are denoted with a black triangle and it states the adverse side effects

Question 23

How often are black triangle medications reviewed

Answer 23

Roughly every 5 years

Question 24

Can a black triangle be reinstated once removed

Answer 24

Yes

Question 25

If a medicine is found to be safe once distributed what happens

Answer 25

It is recalled

Question 26

How many levels of medicine recalls are there

Answer 26

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