Change in Administrative Procedure for Section S Revision for Registered Products (Non Anti-Infectives) with the Expiration of Registration Starting 1 January 2020

Please be informed that, with effective 17 Dec 2019, there has been a change in Administrative Procedure for Section S Revision for Registered products (Non Anti-Infective) with the expiration of the registration starting 1 January 2020.

DOWNLOAD 

Therefore, Form RegA1: Application Form for Section S Revision for Product Registered Before the Implementation of Directive on Regulatory Control of API 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. 

Further to the change, new reference documents are available for:

1. Guidance Note for API Information, Version 4.1  DOWNLOAD

2. List of Updates for Guidance Note for API information, Version 4.1 DOWNLOAD

2. Frequently Asked Questions  DOWNLOAD

        3. Form RegA2 (For Anti-Infectives ONLY)  DOWNLOAD

Should further clarification on Section S Revision is required, please email us at apireg@npra.gov.my.