Overview
In Malaysia, health/food supplements with general and functional claims are regulated under the category of medicinal products requiring registration and approval from the National Pharmaceutical Regulatory Agency (NPRA). A health supplement is a product used to supplement a diet and to maintain, enhance, and improve the healthy function of the human body. It is presented in small units dosage forms such as capsules, tablets, powder, and liquids. It may contain vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances. It may also contain substances derived from natural sources, including animal, mineral, and botanical materials in the form of extracts, isolates, concentrates, and metabolites.
Under the food product regulation for any foreign manufacturer, it is mandatory to have a local entity or local presence in Malaysia to carry out the Regulatory services and registration procedures with the NPRA.
The NPRA has strict guidelines for food product registration. It also has strict policies about the types of claims [General or Nutritional Claims; Functional Claims (medium); Disease Risk Reduction Claims (high)] made by the health supplement. If the product complies with all the requirements specified by the NPRA, it can be registered and sold in Malaysia.
Submissions for food product registration in Malaysia need to be done online via Quest 3+ on the National Pharmaceutical Regulatory Agency (NPRA) website. The dossier must be submitted in English or Bahasa Malaysia.
The registration process is carried out in two (02) steps:
- Product Validation – In this segment, the applicant must submit the data related to product classification, dosage form, ingredients, manufacturer details, and verification.
- Submission of Administration Data and Product Information – In this segment, data related to product particulars, formula, labeling draft, and packaging details must be submitted. Other important documents such as the Certificate of Pharmaceutical Product (CPP), free sale certificate, GMP certificate, and the manufacturer’s license must also be submitted.
Evaluation of the dossier starts after the payment of the registration fee. Once an import license is obtained, the product can be imported to Malaysia for sample analysis. After the evaluation of the dossier and sample analysis, approval/rejection of the product is notified via the Quest 3+ system.
Product Maintenance & Compliance
|
Sr. No |
Application |
Validity |
|
01 |
Validity for Registration Certificate |
Five (05) years from the date of registration |
|
02 |
Renewal |
The renewal application should be submitted six (06) months before the expiration of the existing registration certificate, along with documents, as required in the online Quest 3+ System |
|
03 |
Post Approval Changes (Variations) |
Any change of registered medicine should be sent to the NPRA with relevant documents, on a case-by-case basis |
Freyr Expertise
- Authorized Local Representation
- End-to-end Support for Health Supplements Registration and Food Supplement Registration in Malaysia
- Gap Analysis, Ingredient Review, Claim Review, and Labeling Review
- Food Product Registration in Malaysia
- Product Classification or Food-Drug Interphase Classification with the NPRA
- Preclinical Services (Generation of a scientific report for Regulatory submissions) adhering to the NPRA
- Import License Application with the NPRA
- Change of Product Registration Holder
- Ad-hoc Regulatory Affairs Consultation
