11 Jan 2017

Malaysia:National Pharmaceutical Regulatory Agency (NPRA), earlier known as BFFK

Malaysian National Pharmaceutical Regulatory Agency (NPRA), earlier known as BFFK









Provides the status of registered drug products along with medical devices, cosmetics in online format. It is well managed for each registered product. Complete information of each product is given. Database is easy to understand.
Malaysian National Pharmaceutical Regulatory Agency’s Database also provides the following information

QUEST3+ System
QUEST 2 / QUEST 3 Online Submission System

1. Product Registration
2. Active Pharmaceutical Ingredient (API)
3. Veterinary
4. Cosmetic
5. GLP
6. Clinical Trials – Safety Reporting
7. GMP/GDP
8. Laboratory & Quality Control
9. Licensing
10. Pharmacovigilance - Product Registration Holders
11. Reporting by Consumers
12. ADR Reporting by Healthcare Professionals

LIST OF REGISTERED / NOTIFIED PRODUCTS
DRUG CONTROL AUTHORITY, MINISTRY OF HEALTH MALAYSIA

This database is a cumulative list comprising of drugs registered with the Drug Control Authority since 1985 and cosmetics notified with the Director of Pharmaceutical Services. This list consists of registration number / notification number, product name, name of product registration holder / notification holder and name of manufacturer only.

Search Instructions:
First, select the "Search By" from the drop-down menu below. The selections are searched by Product Name, Product Registration Number / Notification Number, Registration Holder / Notification Holder, Active Ingredient / Cosmetic Substance and Manufacturer. By default, if you do not select the "Search By" the system will search your query based on Product Name
.

Enter the complete or a portion of the keyword of the criteria you are searching and click the "Search" button. (Eg. para, poll, ginseng, MAL2003 / NOT2003). For normal search criteria, please use the Search feature by clicking the button below.

For advance search criteria, please use the Advance Search feature by clicking the button below.

Starting from 1 January 2008, all cosmetic products are using Notification Number as a confirmation that product already meets the current local requirements. Details can be found under the Control of Cosmetic Products in Malaysia.


Product Type:
  • All Registered Product Other Than Cosmetics 
  • Cosmetic Products Only
http://npra.moh.gov.my/index.php/about-npcb/npcb-info/quest3plus-product-search

Language: English/ Bahasu

Product Codes:
A: Scheduled Poisons
X: Non-scheduled Poisons (over the counter products)
T: Traditional Medicines
K/KE: Cosmetics
C: Contract Manufactured
E: Export Only
R: Repacked
S: Second source

Recommended Retail Price
Drug Control Authority (DCA) has decided at 110th meeting to include recommended retail price as a supplementary data for manufacturing and import licence application. These information would be useful as a guidance to the public. Where the Registrant has not provided the Bureau with updated RRP data, the database will display the price as "not available".

For Pricing details of registered drugs please see the earlier post as follows:

https://prtmnews.blogspot.in/search/label/Malaysia

Published registered drug database provides the following results of each product.

  • Product Name:
  • Holder:
  • Address:
  • Phone No:
  • Manufacturer:
  • Address:
  • Ingredients Information / Substance Name 
  • Packaging Information/
  • Quantity

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