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Is advertisement on aesthetic services allowed?

Aesthetic services are categorised as medical treatment and should be conducted by a registered medical practitioner. It can only be advertised by clinics/ private hospitals that are licensed/ registered by CKAPS with the approval from MAB.

Must advertisements related to services offered at fitness centers get approval from the MAB?

MAB does not approved advertisements related to services offered by fitness centers. According S4A Medicines (Advertisement and Sale) Act 1956, approval of advertisement can only be given to 4 facilities which are private clinic, private hospital, private medical laboratory and private radiological clinic operated by a registered medical practitioner having a valid annual practicing certificate under the Medical Act 1971.

Is advertisement related to Tongkat Ali and Kacip Fatimah drinks require approval from Medicine Advertisements Board?

Tongkat Ali and Kacip Fatimah drinks or any food or beverage products are classified as a food product and are regulated by Food Safety and Quality Division, Ministry of Health. Advertising for food products is not under the purview of Medicine Advertisements Board and thus does not require approval from MAB. However, advertisements of food products are not allowed to make any medical claims, such as enhancing sexual performance, reducing joint pain, lowering blood sugar level and so on. For any inquiries regarding the advertising of food products, please visit the official website of FSQD at https://hq.moh.gov.my/fsq/ or via official telephone 03-8885 0796 / 03-8885 0797.

Why does MAB make many changes to the advertisement format submitted?

Approval for any advertisement format is based on the Medicines (Advertisement and Sale) Act 1956 and its regulations. In addition, advertisement formats must also comply with advertising guidelines and policies issued by the MAB. MAB has the right to amend any claims and advertisement formats that do not comply with the act, guidelines, and policies.

Am I allowed to rearrange the format, without altering the content of the advertisement that has been approved by MAB? Do such amendments require approval from the MAB?

Amendments to the layout format without altering the content of the advertisement that has been approved are permitted without requiring approval from MAB. However, the applicants must inform by notifying the secretariat via email to avoid any confusion with pharmacy enforcement officers during the screening process.

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.

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