Data Requirements for the Renewal of Marketing Authorizations for human medicinal products

sfda_gov_sa · regulation · processed · 3 chunks

الطريقه العامه للدفاع واللعب
Saudi Food & Drug Authority
SFOA
Data Requirements for the Renewal of Marketing Authorizations for human medicinal products
Version 2.0
<table><tr><td>Date of implementation</td><td>10 December 2011</td></tr></table>
DS-REQ-009-V02/111210
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SFDA
Data Requirements for the Renewal of Marketing Authorizations for human medicinal products
Version 2.0
Saudi Food & Drug Authority
Drug Sector
For Inquiries
SDR.Drug@sfda.gov.sa
For Comments
Drug.Comments@sfda.gov.sa
Please visit SFDA's website at for the latest update
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DS-REQ-009-V02/111210
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SFDA
Saudi Food and Drug Authority
Vision and Mission
Vision
To be a leading international science-based regulator to protect and promote public health
Mission
Protecting the community through regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides and feed
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SFDA
Document Control
<table><tr><td>Version</td><td>Author</td><td>Date</td><td>Comments</td></tr><tr><td>1.0</td><td>Executive Directorate of Product Evaluation and Standards Setting</td><td>10 December 2011</td><td>Final</td></tr><tr><td>1.1</td><td>Executive Directorate of Product Evaluation and Standards Setting</td><td>24 February 2013</td><td>Updated</td></tr><tr><td>1.2</td><td>Executive Directorate of Product Evaluation and Standards Setting</td><td>26 May 2013</td><td>Updated</td></tr><tr><td>2.0</td><td>Executive Directorate of Regulatory Affairs</td><td>15 June 2022</td><td>Updated</td></tr></table>
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SFDA
What is New in version no. 1.3 ?
The following table shows the update to the previous version:
<table><tr><td>Section</td><td>Description of change</td></tr><tr><td>Module 1</td><td>Delete:– 1.3 Product Information– 1.7 Certificates and Documents</td></tr><tr><td>Module 3</td><td>Delete:– 3.2. S Drug Substance– 3.2. P.5 Control of Drug Product– 2. P.8 Stability</td></tr></table>
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SFDA
Table of Content:
1. Introduction: 7
2. Scope: 7
Module 1: 8
1.0 Cover letter 8
1.2 Application Form....8
1.8 Pricing....8
1.8.1 Price list 8
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DS-REQ-009-V02/111210
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SFDA
1. Introduction:
This document has been developed to assist applicants in the preparation and submission of drug applications for renewal of marketing authorization.
The objectives of this guideline are to classify the requirement of submitting a renewal of marketing authorization and to provide applicants with recommendations on the data required for which may impact the assessment of the drug products.
The following notes should be taken into consideration when submitting any renewal application:
- Renewal applications have to contain a consolidated version of the file, containing at least the documents listed below and presented in accordance with the appropriate headings and numbering of the eCTD format.
- Applicants should be aware that deficient documentation can lead to rejection of the application. In addition, submitting redundant or irrelevant information may delay approval procedures.
2. Scope:
This guideline considers issues associated with the processing of renewals with the aim of giving procedural guidance to marketing authorization holders (MAHs) and applies to all types of human medicinal product registration pathways that are described in the Regulatory Framework for Drugs Approval.
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SFDA
3. Documents to submit:
Module 1:
1.0 Cover letter
• Cover letter must contains the following:
- All information's about the product which includes the following :
1. trade name
2. generic name
3. sub-product number
4. request number
5. strength
6. dosage form
7. manufacturer
8. MAH and agent
- Cover letter must be applied in an Original MAH paper form.
- Name of the person authorized to sign on behalf of the company
- Cover letter must be signed and Stamped from MAH authorized person.
1.2 Application Form
This section should contain the renewal application form according to Request Details in eSDR.
1.8 Pricing
1.8.1 Price list
This section should include the following:
- A price list shall include the price of the drug product in countries listed in the Price Certificate Forms as per pharmaceutical pricing rule.
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SFDA
Abbreviations:
eCTD electronic common technical document.
SFDA Saudi food and drug authority.
MAH Marketing authorization Holder.
eSDR electronic Saudi drug registry.
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