Licensing

Question 1

Why do we license?

Answer 1

Illegal to manufacture, sell, supply, export or import..…without a licence, certificate or exemption

Question 2

What is a medicine?

Question 3

What are the different application procedures for marketing authorisation/ product licensing?

Answer 3

• Centralised (e.g. across EU - EMA)
• National (e.g. MHRA for UK)
• Decentralised (e.g. apply to few authorities/countries but not all)
• Mutual Recognition (e.g. license in one state but then after is licensed in another member state if application is thorough enough)
• Abridged application (design for generic manufacturer)

Question 4

What is marketing authorisation?

Question 5

What does licensing authority consider?

Answer 5

Safety, quality and efficacy

Question 6

How long is a MA valid for?

Answer 6

5 years

Question 7

When can a licensing authority be revoked, suspended or varied?

Answer 7

Any time

Question 8

When is a manufacturer’s licence required?

Answer 8

For manufacturing/assembling relevant product (e.g. medicinal product)