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How to identify medicines that are registered with MOH?

All medicinal products in Malaysia, including imported medicines, must be registered with the Ministry of Health Malaysia (MOH)  before they can be sold or marketed to consumers. Registered products are guaranteed in terms of Safety, Quality and Efficacy. Registered medicines must carry both registration numbers (ie  MAL20125467T) and  Meditag Hologram labels on its label or packaging. A valid registration number begins with “MAL”, followed by 8-digit numbers and ends with an alphabet to indicate their registration category. The categories of registered product are as follows:

A – Controlled medicines
X – Over the counter medicines (OTC)
T – Natural Products/ Traditional Medicines
N – Health Supplements
H - Veterinary Products

In addition, there may be administrative codes used by the National Pharmaceutical Regulatory Agency after the product category. The administrative code is:

C  – Contract Manufactured (the product is manufactured by a GMP certified contract manufacturer)
E – For Export Only (FEO) (the product is to be sold for export only and not for sale in the local market)
R –  Packed and/or repacked (the product is packed and/or repacked by an approved GMP certified packer and/or repacker)
S – Second source (the product is from a second source/ approved second manufacturer)
Y –  Orphan products
Z – Products gazetted as zero-rated under the Goods and Services Tax Act 2014, Goods and Services Tax (Zero-Rated Supplies) Order 2014.

Users can check the registration status of a product through the http://npra.moh.gov.my / OR by contacting the National Pharmaceutical Regulatory Agency at 03-78835400.

In that website you can click on the 'Product Search' icon. Search for registered products can be done using:

•    Product Name
•    Registration Number
•    Registration Holder Name
•    Active Ingridient
•    Manufacturer / Importer Name

If the product is a registered product, the registration status will be displayed. After checking the registration number, you are advised to check the validity of the hologram label through a pharmacist at nearby hospital, clinic or pharmacy.

In addition, people can also download the NPRA Product Status application from the Google Play Store to check the status of their product registration.

 

How long does it take to obtain authorization to import unregistered medicines?

Authorizations to import unregistered medicines is only given for life-threatening cases and the patients must be under supervision of a registered medical practitioner. Complete applications will be processed within 14 days 

Can an unregistered product be imported into Malaysia?

Importation of products that are not registered with the DCA is an offence under Control of Drugs and Cosmetics Regulations 1984. However, special exemption may be granted for the treatment of life-threatening illnesses as provided under Regulation 15 (6) Control of Drugs and Cosmetics Regulations 1984. Complete applications must be submitted to the Pharmaceutical Services Division.

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How to lodge complaint regarding unregistered medicines?

Complaints can be lodge either by phone, e-mail or in writing to the Senior Director of Pharmaceutical Services. You can also contact the nearest Pharmacy Enforcement Branch office.