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 This email address is being protected from spambots. You need JavaScript enabled to view it. 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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