Pharmaceutical Product - Drug

We help our client to register their Drug products in Malaysia.

Pursuant to the Control of Drugs and Cosmetics Regulations 1984, all Drug in a pharmaceutical dosage form intended to be used or capable or purported or claimed to be capable of being used on humans or any animals, whether internally or externally, for a medicinal purpose is 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.

Medicinal purpose means any of the following purposes:
i. alleviating, treating, curing or preventing a disease or a pathological condition, or symptoms of a disease;
ii. diagnosing a disease or ascertaining the existence, degree or extent of a physiological or pathological condition;
iii. contraception;
iv. inducing anaesthesia;
v. maintaining, modifying, preventing, restoring or interfering with, the normal operation of a physiological function;
vi. controlling body weight; vii. general maintenance or promotion of health or well-being.

Registration of Drugs (Poison & Non-Poison Drug) 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 Drug 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. Drug Registration
After ingredient assessment & formulation advice, we shall proceed to labeling 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 Drug products after the approval of the importer’s license.

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

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