Human medicines: Regulation, licensing and advertising

Question 1

Which agency is responsible for the safety and use of medicines?

Answer 1

MHRA

Question 2

All medicines sold or supplied in the UK must have what?

Answer 2

A UK marketing authorisation which has to be issued by the MHRA

Question 3

What is a MA?

Answer 3

Licenses issued by the MHRA for a specific medicinal product

Question 4

What Is Summary Product Characteristics (SPCs)?

Answer 4

• Description of a medicinal products properties and conditions associated with its use
• Contains information on safe and effective use for healthcare professionals

Question 5

Why do you need a manufacturer’s license?

Answer 5

Required to manufacture or assemble human medicines or import them
- need an ML before applying for an MA

Question 6

To get an ML what must the company comply with?

Answer 6

Good Manufacturing Practice (GMP):
- manufacturing must be of consistent high quality
- be appropriate to their intended use and
- meet the requirements of the MA or product specfication

Question 7

What does the Wholesale Dealer’s license specify?

Answer 7

• The premises from which distribution may be carried out
• Outlines the Responsible Person, detail of emergency plan for product recall and record keeping

Question 8

What does the wholesale dealer’s license allow?

Answer 8

• Sell, supply, offer for sale or supply pharmacy, POM, GSL medicines wholesale
• Import unlicensed medicinal products from countries inside the EEA
• Export medicinal products to countries of EEA

Question 9

Describe the phases of Clinical Trials

Answer 9

Phase 1 - new product initially tested on a small group of healthy adults; researchers will be focusing on dosage, safety profile and side effects etc

Phase 2 - people affected with the disease the drug has been manufactured for will be included; compare with placebo to see if drug is effective

Phase 3 - a much larger number of people, effectiveness will be investigated and its use over. longer period of time and potentially other countries involved to bring diversity - compared to other treatments

Phase 4 - Drug is licensed and the effect of the drug, side effects and safety profile will continue to be monitored

Question 10

What is the yellow card scheme?

Answer 10

Anyone (someone from the public or healthcare professional) can report suspected issues or adverse effects of a medicine
- Early warning scheme to detect issues

Question 11

What is a black triangle?

Answer 11

A black triangle is associated with new medicines and vaccines to show that the medicine is still not completely safe and not all side effects have been identified