Procedure: NRA Classification
Country: Global Procedure
Version #: 11/28/2023
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

ID: GP-PhR-CLS-SR
Category: Pharmaceuticals
Validity: Until MA obtaining or NRA update
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.

SUMMARY

Divergent classification by national regulatory agencies is pivotal for companies to align with the distinct requirements of each target market. In the realm of regulatory affairs, it plays a crucial role in ensuring adherence to legal standards, securing product approvals, meeting safety and efficacy benchmarks, upholding quality specifications, complying with labeling and packaging guidelines, overseeing post-market surveillance, navigating clinical trial regulations, and formulating an effective global regulatory strategy. Furthermore, it serves as a strategic imperative for cost management, especially when local classifications differ or become more stringent, necessitating additional expenditures for comprehensive studies to meet compliance with local standards.

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Must-Have Requirements, Recognized Standards, and Certifications:

  • POA
  • Questions, Suggestions and Proposals

Nice-to-have:

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

Typical Gaps and Deficiencies: Insufficient understanding of current requirements and updates, bad risk assessment

Implementation Period: Immediately

Deliverables: NRA Classification Assessment

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

Document processing

Executor

week 2

1

    

  0.6

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

Application development with respect to current updates

Executor

week 5

1

    

  I.2

Application submission to NRA

Executor

week 6

2

   

Сonfirmation 

II

Results Acceptance

       

  II.1

Acceptance of NRA response or query

Executor

week 8

2

    

  II.2

Communication with MHA and NRA when needed

Executor

week 10

1

   

NRA Classification

F

Final Phase In-house Post-Authorization Activity

       

  F1

Service Acceptance Certificate signing

MAH

week 11

1

    

  F.2

Final Invoice

Executor

week 11

1

    

  F.3

Final Payment

MAH

week 11

1

    

  F.4

Contract Termination

Executor

week 11

1

    

  F.5

Archiving and limiting access

Executor

week 11

1

   

Archiving

 

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