Industry

Can a medicine without 'MAL' registration number be advertised in Malaysia?

No, medicines without MAL registration number are considered unregistered products and are not allowed to be sold and advertised in Malaysia. Medicine Advertisements Board (MAB) will not approve application of unregistered product’s advertisement.

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 https://www.npra.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 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.

Are there any control measures on pharmaceutical products containing animal-derived materials?

Yes, there are.

Pharmaceutical product registration holders must label, and declare on the label, if the product contains animal-derived materials such as magnesium stearate, glycerine or gelatine. Should the company fail to do so, the MOH has the right to suspend or deregister said product.

Even though determining whether a medicine is free from animal-derived substances be it bovine, porcine or other involves a complex process, detection is possible with the current advanced technology available.

The National Fatwa Council Committee convened and decided that pharmaceuticals/medicines containing prohibited substances should only be consumed if there are no other medicine of halal source available, and it is used in an emergency. Please contact JAKIM for more information.

Is there any procedure on registration of cosmetic product?

A cosmetic product needs to be notified by the Drug Control Authority (DCA). For further information please contact 0378835400 or www.npra.gov.my.

Does a pharmacist on study leave required to collect CPD points?

Yes, a pharmacist on study leave is required to collect 40 CPD points per year

MPS Pharmaceutical Scientific Conference

Location/place: 
Hotel Istana
Date: 
Wednesday, 31 October 2012 to Friday, 2 November 2012

Methadone Replacement Therapy

Methadone Replacement Therapy (MRT) is one of the "Harm Reduction" program established for opioid abusers. The aim of this program is mainly to prevent blood-borne viral infections (HIV, Hepatitis C, Hepatitis B) due to needles sharing. Methadone Replacement Therapy takes place when a patient is prescribed with Methadone by a Medical Officer, and the consumption is supervised by a Pharmacist.

Clinical Pharmacy Service

Clinical pharmacy services offer monitoring services for warded patients by the pharmacists. The services including therapeutic drug monitoring, medication counseling and dispensing medications to discharged patients. Clinical pharmacists are involved in ward round together with other medical team. Clinical pharmacists are responsible for ensuring that patient treatment is at an optimal level, to ensure the patient's condition is stable, provide counseling as well as to promote the proper and effective use of drugs.

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