Module 6

04/10/2024

49

UK OTC Switch applications

• MAJOR

• STANDARD

• SIMPLE (”me too”)

• If prescription-only medicine (POM) retained ● New MA required. ● Different names required

The Organisation for Professionals in Regulatory Affairs

49

50

OTC Switch

• Application routes:

● Variation of an existing MA ● In conjunction with abridged application ● Creation of duplicate MA and then change legal classification.

The Organisation for Professionals in Regulatory Affairs

50

25