Procedure: Line (MA) Extension
Country: Global Procedure
Version #: 01/04/2024
Author: Vlad Reznikov
Editor: Daria Kostiuchenko

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

                                                              

SUMMARY

Certain changes to a Marketing Authorisation (MA), have to be considered to fundamentally alter the terms of this authorisation and therefore cannot be granted following a variation procedure. These changes are to be submitted as ‘Extensions of marketing authorisations’ and are listed in Annex I (EU) of the Variations Regulation. This Annex lists two main categories of changes requiring an extension of marketing authorisation for pharmaceutical products (except different immediate containers):
  • changes to the active substance;
  • changes to the strength, pharmaceutical form and route of administration.
The assessment timeframe is typically the same as for an initial marketing authorisation, also in some countries Line (MA) Extension is not possible and considered as a New MA by NRA. In some cases Line (MA) Extension application could be grouped with a Type II variation for a new indication/s.
Gp Pharmaceuticals Line (ma) Extension Simplified Regulations Card Gantt Chart Page 0001

Must-Have Requirements, Recognized Standards, and Certification:                                                                

  • eCTD Module 1, PI in MS Word
  • eCTD Module 3 relevant quality info, RMP (Word) 
  • Updated Module 2, Addendum to quality summaries, non-clinical and clinical overviews                                                                  

Nice-to-have:

  • Confirmation of the Line (MA) Extension                                             
  • Pre-submission checklist                                                               

Typical Gaps and Deficiencies: Insufficient or missing regulatory documentation, confusing dossier presentation                                                           

Implementation Period: Immediately                                                                

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

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

Submission

       

  I.1

Providing documents and registration file

MAH

week 5

1

    

  I.2

Ensure alignment with local regulatory guidelines

Executor

week 6

2

    

  I.3

Translations and document processing

3rd party

week 8

2

    

  I.4

Filling out the application form

Executor

week 10

1

    

  I.5

Approval of the application form

MAH

week 10

1

    

  I.6

Submission of the MA Application and Reg. File

Executor

week 11

1

   

Application

  I.7

    NRA payment

MAH

week 11

1

   

Confirmation

II

NRA Evaluation

       

  II.1

Application review

NRA

week 12

2

    

  II.2

Registration file review

NRA

week 13

4

    

  II.3

Determining of Specific lab testing requirements

NRA

week 17

1

    

  II.4

State-approved lab contracting

Executor

week 18

2

    

  II.5

Samples and Ref. Standards permit obtaining 

Executor

week 20

1

    

  II.6

Samples and Ref. Standards shipping

MAH

week 21

2

    

  II.7

Samples and Ref. Standards custom clearance

Executor

week 23

1

    

  II.8

Optional clinical evaluation (in some countries)

Executor

week 24

8

    

  II.9

Verification of medication guidelines and drug labeling

NRA

week 32

2

    

  II.10

Verification of DHCP Letter and Communication Plan

NRA

week 32

2

    

  II.11

Approval or Query

NRA

week 33

1

   

Approval or Q&A

III

Q&A

       

  III.1

Analysis and addressing Qs to MAH

Executor

Mnth 8

1

    

  III.2

Answering with relevant documents

MAH

Mnth 8

1

    

  III.3

Official Response Evaluation

NRA

Mnth 8

1

    

  III.4

Approval or Query

NRA

Mnth 8

1

   

Approval or Q&A

IV

Approval

       

  IV.1

Market Authorization Approval

NRA

Mnth 9

1

    

  IV.2

Reporting to MAH, compliance check

Executor

Mnth 10

1

   

Approval

  IV.3

Listing in the state register

Executor

Mnth 10

1

   

Listing

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate signing

MAH

Mnth 10

1

    

  F.2

Final Invoice

Executor

Mnth 10

1

    

  F.3

Final Payment

MAH

Mnth 10

1

    

  F.4

Contract Termination

Executor

Mnth 10

1

    

  F.5

Archiving and limiting access

Executor

Mnth 10

1

   

Archiving

 

                              Feel free to submit a Request for Proposal (RFP) for a specific country or territory to info@patternofusa.com