Procedure: Type IA and IA-IN variation notifications
Country: Global Procedure
Version #: 01/03/2024
Author: Mariya Ivanova
Editor: Daria Kostiuchenko                                                          

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

SUMMARY

Type-IA variations are minor variations that have only a minimal impact or no impact at all, on the quality, safety or efficacy of the medicinal product, and do not require prior approval before implementation (‘do-and-tell’ procedure). The Classification Guideline clarifies the conditions that must be met for a change to be considered a type-IA variation.
Such minor variations are classified in two subcategories, which impact on their submission:

  • IAIN Type-IA variations requiring immediate notification

The Classification Guideline specifies the type-IA variations that must be notified (submitted) immediately to the NRA or EMA following implementation, in order to ensure the continuous supervision of the medicinal product.

  • IA Type-IA variations not requiring immediate notification

Variations that do not require immediate notification may be submitted by the MAH within 12 months after implementation, or may be submitted earlier should this facilitate dossier lifecycle maintenance or when necessary, to ensure that the latest product information is reflected in certificates of pharmaceutical products, for example.

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Must-Have Requirements, Recognized Standards, and Certification:

  • Annex A Comparative Table
  • Annex IV Elements
  • Grouping of Type IA/IAIN variations
  • Applicable SmPC or Annexes I, II, IIIA/B                       

Nice-to-have:

  • Confirmation of the original variation                                                  
  • Pre-notification checklist                                                                

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

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

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

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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