License Category (LM_LIC_CATEGORY)

Code listed data in the following table has been added and is synchronized with the License Category flex bucketing code list as indicated in the following table. New language attribute E2B_R3 has been added to flex bucketing code list ID, LICENSE_CATEGORY.

Category E2B_R3

During early post-marketing phase vigilance

1

Within 2 years after approval

2

Unapproved

3

During clinical trial for partial change

4

Not applicable

5

During re-examination period (Instruction required drugs)

6

During post-marketing surveillance (PMS) (Instruction required drugs)

7