Manufacturer Licence / Wholesale Dealer LicenceExemptions from Licensing (28/01/19)

Question 1

What does a manufacturer licence allow holder do?

Answer 1

• Manufacture and/or assemble licensed medicinal products, including export to a country outside the EEA
• Import licensed medicinal products from countries outside the EEA

Question 2

Which of the following require a licence:Manufacturing, Assembly?

Answer 2

Both manufacturing and assembly

Question 3

What does a Manufacturer ‘Specials’ Licence allow holder to do?

Answer 3

• Manufacture unlicensed medicines ‘specials’

- Import unlicensed medicinal products from outside the EEA

Question 4

What is the law that allows manufacture and supply of unlicensed medicinal products?

Answer 4

Specials

Question 5

What are the ‘Specials’ manufacturing/ dispensing services – conditions?

Answer 5

A) Medicinal product is supplied—
-to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or
-supplementary prescriber; or
for use under the supervision of a pharmacist in: a registered pharmacy or a hospital or a health centre

B) No advertising

C) Adequate supervision & procedure for manufacture
to meet specified requirements

D) Written records of manufacture or assembly kept
Available for inspection

E) Manufacturer holds Manufacturer ‘Specials’ Licence