Traditional Medicine

We help our client to register their Traditional Medicine products in Malaysia.

A Traditional Medicine means any product employed in the practice of indigenous medicine, whereby the drugs used consist of one or more naturally occurring substances of plant, animal or mineral or part thereof, or in extracted form or non-extracted form, and any homeopathic medicine.
(Indigenous Medicine - means a system of treatment and prevention of diseases involving the traditional use of naturally occurring substances.)

Pursuant to the Control of Drugs and Cosmetics Regulations 1984, all Traditional Medicine products are required to be registered with Drug Control Authority (DCA) of the Ministry of Health (MOH) Malaysia prior to being manufactured, sold, supplied, imported or possessed or administered.

Registration of Traditional Medicine requires proof of stability, efficacy, quality, safety and are subjected to stringent screening and testing as well as regular and random post-marketing surveillance and testing.

The process for registering the Traditional Medicine products as follow:-
1. Pre-Registration Ingredient Assessment Before the product can be registered with our MOH, each and every ingredient must be assessed to make sure the active ingredients and/or excipients are permissible to be used and do not over the limit determined by our MOH.

2. Traditional Medicine Registration After ingredient assessment & formulation advice, we shall proceed to labelling compliance advice and documentation advice. Upon completion, we shall proceed to the submission. MOH will take about 5-6 months to assess the documents submitted to them. If every requirement is complied and there is no further query / information needed, then, the approval letter / MAL will be issued.

3. Importer’s License Application (For those who have yet to obtain the drug importer’s license only) After the grant of MAL no., your company needs to apply an importer’s license and our MOH will take approximately another 3 months to process the application. You are only entitled to import the healthy supplement product after the approval of the importer’s license.

Please contact PIC (+603-7972 3579 / +6016-666 1137) for more information on the Traditional Medicine products in Malaysia.

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