Application for Section S Revision for Registered Product

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Regulatory Control of API for Registered Products 

This section is applicable for registered products containing Scheduled Poison with the expiration of the registration period starting 1 January 2020. 

At the point of writing, NPRA has identified anti-infective APIs as the selected category for assessment purposes. This category was selected based on current public health needs and risk-based approach which may be extended to other categories from time to time. For further information, please refer to documents below and Guidance Note for API information: Part C.

With effective 17 Dec 2019, there has been a change in Administrative Procedure for Section S Revision for Registered products (Non Anti-Infective). Therefore, Form RegA1 has been deactivated and replaced with Form RegA2: Application Form for Section S Revision for Products (Anti-Infectives) Registered Before the Implementation of Directive on Regulatory Control of API. 

For registered products not containing anti-infective APIs, part II S information shall be kept by the Product Registration Holders (PRH). It is not necessary to upload to QUEST 3+. PRH are responsible to ensure that the API used in the finished product fulfills NPRA’s requirement. NPRA reserve the right to request PRH to provide the required API information whenever needed.

 

Document Name Download Updated

Form RegA2: Application Form for Section S Revision for (Anti-Infective) Products Registered Before the Implementation of Directive on Regulatory Control of API

 Dec-2019

Appendix 1: Checklist for Required API Information (Anti-Infective API)

 Dec-2019

 

Appendix 3: Administrative Procedure For Regulatory Control of API in Registered Product (Version 4.1)

 Dec-2019

Jadual Pembukaan “Section S Revision” QUEST 3+ (untuk Produk Anti-Infektif) Tahun 2023

 Dec-2022

Jadual Pembukaan “Section S Revision” QUEST 3+ (untuk Produk Anti-Infektif) Tahun 2024

 Nov-2023
Frequently Asked Questions (FAQs) : Please refer to (B) API in Registered Products  May-2024

 

 

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