PHASE

TASK

TASK

START

DURATION

Fee

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

0

In-house Pre-Submission Activity

  0.1

NDA signing or validation

Executor

week 1

1

  0.2

Contract Closing

MAH

week 1

1

  0.3

POA issuance and shipping

MAH

week 1

1

  0.4

Invoice is sent to MAH and paid

Executor

week 1

1

  0.5

Legal Document processing

Executor

week 2

1

  0.6

Legal Document Translations, Notary, and Apostilles 

3rd party

week 2

2

  0.7

SOW is approved by MAH

Executor

week 4

1

SOW

I

Assignment

  I.1

Communication chain setup

Executor

week 5

1

  I.2

NRA verification

Executor

week 6

1

  I.3

Update Labeler Code SPL NRA records  

Executor

week 6

1

  I.4

Update Registration SPL NRA records

Executor

week 6

1

NRA records

II

Activity

  II.1

Receiving information and documents from NRA

Executor

year 1

52

  II.2

Emergency communication with NRA and MAH    

Executor

year 1

52

  II.3

Acting as a contact point for compliance activity  

Executor

year 1

52

  II.4

Assisting NRA in scheduling inspections

Executor

year 1

52

  II.5

Regular communication and reporting to MAH

Executor

year 1

52

Report

III

Discontinuation

  III.1

Discontinuation and communication  plan development

Executor

TBD

2

  III.2

NRA notification

Executor

TBD+3w

1

  III.3

Deregistration with NRA

Executor

TBD+3w

1

  III.4

Labeler code inactivation

Executor

TBD+3w

1

  III.5

Drugs delisting (with last lot expiration date)

Executor

TBD+3w

1

  III.6

Closeout activities for healthcare providers, patients, etc.

Executor

TBD+18

1

Report

F

Final Phase In-house Post-Authorization Activity

  F.1

Service Acceptance Certificate signing

MAH

TBD

1

  F.2

Final Invoice

Executor

TBD

1

  F.3

Final Payment

MAH

TBD

1

  F.4

Contract Termination

Executor

TBD

1

  F.5

Archiving and limiting access

Executor

TBD

1

Archiving