Traditional, OTC Or Cosmetic? Choosing The Right Registration Route

Why does product category matter?

Before development begins, you need to know which category your product belongs to. The category decides the registration route, the documents required, the claims allowed on the label and how long it takes before the product can be sold.

Registered products with a MAL number

Pharmaceutical, traditional and health supplement products are registered with the National Pharmaceutical Regulatory Agency (NPRA). Approved products carry a registration number beginning with MAL. The letter at the end shows the category:

• T — traditional medicine
• X — non-controlled OTC medicine
• N — health supplement / natural product
• H — homeopathic preparation
• A — controlled medicine (including scheduled poisons)

Cosmetics with notification

Cosmetics such as skin, hair and body care are not registered with a MAL number. Instead they are notified to NPRA and carry a cosmetic notification number. Claims on cosmetic labels are also limited — a product that claims to treat a disease is no longer a cosmetic.

Claims decide the category

The same cream can fall into different categories depending on what it claims. A moisturising cream is a cosmetic; a cream claiming to relieve muscle pain may be a traditional or OTC product. That is why category and claims should be settled early in the formulation discussion.

How we help

Sari Tani Desa's advisory service covers traditional MAL registration (oral and external), external OTC and cosmetic notification. Also refer to the latest guidelines at npra.gov.my, as requirements can change. See our advisory services.