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

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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 

2. Frequently Asked Questions  

        3. Form RegA2 (For Anti-Infectives ONLY)  

 

Should further clarification on Section S Revision is required, please email us at Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya.