Unlicensed Use

Question 1

What are Unlicensed Medicines?

Answer 1

Those medicinal products without a UK Marketing Authorisation as issued by MHRA

Licensed products may be identified by PL or MA followed by number. A guarantee of quality, safety and efficacy.

Question 2

Unlicensed use/ “off-label”?

Answer 2

Using a Licensed Medicinal Product outside what is written in the Summary of Product Characteristics.

1. Age
2. Dose
3. Condition

Question 3

Where can you find info about dealing with specials?

Answer 3

RPSGB guidance

Question 4

Where can you find guidance about preparing unlicensed medicines?

Answer 4

General Pharmaceutical Council

Question 5

MHRA Guidance Note 14 about supply of unlicensed medicines

Answer 5

Use of Unlicensed Medicine only justified when there is no licensed medicine which fully meets patient’s clinical needs– not cost, convenience or operational.

• All in supply chain aware of medicine status
• Records of supply to be kept for 5 years

Question 6

Hierarchy of risk - based on product origin

Answer 6

1. UK licensed medicine
2. Off label use of UK licensed medicine
3. Imported product licensed in country of origin
4. UK manufactured product made in MHRA licensed facilities
5. Extemporaneously dispensed medicine
6. Imported product not licensed in country of origin
7. Food supplement /cosmetics

Question 7

What is tested for UK licensed medicines? (3)

Answer 7

1. Quality
2. Safety
3. Efficacy