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

Bintang tidak aktifBintang tidak aktifBintang tidak aktifBintang tidak aktifBintang tidak aktif
 

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. 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Selasa 17 Mei 2022, 16:02:12.
© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Search

Choose Your Language

Menu Utama