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.
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
2. List of Updates for Guidance Note for API information, Version 4.1
3. Form RegA2 (For Anti-Infectives ONLY)
Should further clarification on Section S Revision is required, please email us at This email address is being protected from spambots. You need JavaScript enabled to view it..
