Food Supplements Regulatory Support in Malaysia

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 health function of the human body. It is presented in small unit 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 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 needs 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 steps:

  1. Product Validation – In this segment, the applicant must submit the data related to product classification, dosage form, ingredients, manufacturer details and verification.
  2. Submission of Administration Data and Product Information – In this segment, data related to product particulars, formula, labeling draft, packaging details must be submitted. Other important documents such as certificate of pharmaceutical product, free sale certificate, GMP certificate, 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 6 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, case-by-case basis

 

Freyr Expertise

  • Authorized Local Representation
  • End-to-end Product Registration for Health Supplements
  • Gap Analysis, Ingredient Review, Claim Review, Labeling Review
  • 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

Location

Suite 163E, Level 16,
Gurney Paragon Office Tower,
Jalan Kelawei, 10250 George Town,
Pulau Pinang, Malaysia

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