Procedure: MA Renewal
Country: Global Procedure
Version #: 01/17/2024
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

ID: GP-MD-PhR-SR
Category: Pharmaceuticals/MD&IVD
Validity: Lifetime in most countries
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.

                                                              

SUMMARY

The Market Authorization (MA) is typically valid for a period of 5 years in many countries. However, to extend the validity beyond this initial period, an Application for renewal must be submitted at least 9 months prior to the expiration date.
Once renewed, licenses and registrations are not subject to a specific time limit. However, in certain cases, the National Regulatory Authority (NRA/NCA) may order an additional renewal of 5 years to ensure the continued safe marketing of the medicinal product. This additional renewal is implemented to provide further assurance of the post-marketing product’s safety and compliance with regulations.
A smaller set of documents is needed compared to the new MA for renewal. The dossier focuses on safety-related documentation and post-marketing studies. It is important to submit properly legalized administrative documents and specific national forms. Renewal also involves expert evaluation of updated data on the benefit-risk ratio. 

Gp Pharmaceuticals Md&ivd Ma Renewal Simplified Regulations Card Gantt Chart Page 0001

Must-Have Requirements, Recognized Standards, and Certification:                                                                

  • Updated registration file
  • Post-marketing surveillance report

Nice-to-have:

  • Regulatory Intelligence and Strategic Consulting
    see GP-PhR-RI-SR card
  • PSUR/PSMR                                                      

Typical Gaps and Deficiencies: Incomplete post-marketing surveillance, outdated standards, untimely submission, missing or incorrect document confirming the variations or changes                                                 

Implementation Period: After NRA approval                                                      

Deliverables: MA Renewal                                                   

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

Executor

week 3

1

   

POP

I

Review

       

  I.1

Filling of the Application form and renewal dossier

Executor

week 4

1

    

  I.2

Submission and assessment of the Application form

Executor

week 5

1

    

  I.3

Answers on the deficiencies if any

MAH

week 6

2

    

  I.4

NRA payment

MAH

week 8

1

   

Report

  I.5

Update dossier Submission 

Executor

week 9

1

    

II

Studies

       

  II.1

Initial expert assessment of the dossier

NRA

week 10

4

   

Reports

III

Q&A

       

  III.1

Analysis and addressing Qs to MAH

Executor

week 14

1

    

  III.2

Answering with relevant documents

MAH

week 15

1

    

  III.3

Official Response Evaluation

NRA

week 19

4

    

  III.4

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

NRA

week 20

1

   

Approval or Q&A

IV

Approval

       

  IV.1

NRA Letter

NRA

week 21

1

   

Approval

  IV.2

NRA Conclusion publication

NRA

week 22

1

   

Publication

  IV.3

NRA Listing

Executor

week 23

1

   

Listing

  IV.4

Reporting to MAH

Executor

week 24

1

   

Report

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate signing

MAH

week 25

1

    

  F.2

Final Invoice

Executor

week 25

1

    

  F.3

Final Payment

MAH

week 25

1

    

  F.4

Contract Termination

Executor

week 26

1

    

  F.5

Archiving and limiting access

Executor

week 27

1

   

Archiving

 

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