Procedure: Type II variation approval
Country: Global Procedure
Version #: 01/03/2024
Author: Mariya Ivanova
Editor: Daria Kostiuchenko                     

ID: GP-PhR-VII-SR
Category: Pharmaceuticals
Validity: Until next MA expiration or update
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.                            

SUMMARY

A Type II variation is distinct from a marketing authorization extension (line extension) and may exert a substantial influence on the quality, safety, or efficacy of a medicinal product. In the case of Type II variations involving the incorporation of new therapeutic indications or alterations to previously approved ones falling within the purview of scope C.I.6, the evaluation period is typically extended due to the substantial volume of anticipated data. Consequently, Marketing Authorization Holders (MAHs) are encouraged to provide advance notice of their intent to submit an extension of indication or other alterations to the authorized therapeutic indication, ideally six months before the planned submission.

Gp Pharmaceuticals Type Ii Variation Approval Simplified Regulations Card Gantt Chart Page 0001

Must-Have Requirements, Recognized Standards, and Certification:                                                             

  • Annex A Comparative Table
  • Annex IV Elements
  • PAM, PSURs if available                                            
  • Grouping of Type II variations
  • Module 1,2.3,4,5
  • Applicable SmPC, or Annexes I, II, IIIA/B

Nice-to-have:                                                 

  • Confirmation of the original variation                                                  
  • Pre-submission checklist                                                                

Typical Gaps and Deficiencies: Non-eCTD, Insufficient regulatory documentation, confusing dossier presentation                                                         

Implementation Period: With a new batch, defined by MAH and NRA or up to a 12-month period                                                              

Deliverables: Confirmation of the MA terms adjustment                                                              

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

SOW is approved by MAH

MAH

week 1

1

      

SOW

  0.4

POA issuance and shipping

MAH

week 2

1

        

  0.5

Invoice is sent to MAH and paid

MAH

week 3

1

      

POP

I

Submission

              

  I.1

Information assembling, forwarding to Executor

MAH

week 4

1

        

  I.2

Application form and Registration form development

Executor

week 5

2

      

Application

  I.3

Application form and Registration form approval

MAH

week 7

1

        

  I.4

NRA payment

MAH

week 7

1

        

  I.5

Sub-number Request to NRA

Executor

week 8

1

      

Sub-number

  I.6

Application submission to NRA

Executor

week 8

1

      

Submission

II

Official Evaluation

              

  II.1

Official Dossier Evaluation

NRA

week 9

4

        

  II.2

Approval (Skip Ph.III) or Query (GoTo Ph.III)

NRA

week 13

1

      

Approval or Q&A

III

Q&A

              

  III.1

Analysis and addressing Qs to MAH

Executor

week 13

1

        

  III.2

Answering with relevant documents

MAH

week 14

1

        

  III.3

Official Response Evaluation

NRA

week 15

1

        

  III.4

Approval (GoTo Ph.IV) or Query (Rpt. Ph.III)

NRA

week 16

1

      

Approval or Q&A

IV

Approval

              

  IV.1

NRA Conclusion draft verification

NRA

week 17

1

        

  IV.2

NRA Conclusion publication

NRA

week 18

1

        

  IV.3

State Listing update

NRA

week 19

1

        

  IV.4

Reporting  to MAH

Executor

week 19

1

      

Report

F

Final Phase In-house Post-Authorization Activity

              

  F.1

Service Acceptance Certificate signing

MAH

week 20

1

        

  F.2

Final Invoice

Executor

week 20

1

        

  F.3

Final Payment

MAH

week 21

1

        

  F.4

Contract Termination

Executor

week 21

1

        

  F.5

Archiving and limiting access

Executor

week 22

1

      

Archiving

 

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