7. Importation Requirements

Health Supplements
Malaysia

This section provides information on the importation process (shipment, customs, licenses required, and test requirements). 

7.1 Shipment Declaration

There are no importation requirements specific to “Health Supplements”. This category should comply with the requirements in Section 7.1 of 7.0 Importation Requirements of the “General Foods” guidebook.

7.2 Customs Procedure

There is no customs procedure specific to “Health Supplements”. This category should comply with the requirements in Section 7.2 of 7.0 "Importation Requirements" of the “General Foods” guidebook.

7.3 Manufacturing License

“Health Supplements” should comply with the requirements in Section 7.3 of 7.0 Importation Requirements of the “General Foods” guidebook.

A manufacturing license issued by the Competent Authority of the country of origin is required for import permit application [1]. 

7.4 Test for Importation

Inspection for each imported consignment is not mentioned by the regulation. However, in accordance with the Post-market Surveillance Guideline from the NPRA, the PRH must ensure that products marketed are in accordance with the standards and requirements of the Authority.

Registered products may be sampled and tested for compliance with official or pharmacopoeial standards or specifications agreed upon by the manufacturer. Labels and package inserts of the samples may also be checked to ensure compliance with the requirements approved.

The Authority shall take necessary action on products that do not conform to the standards/specifications and requirements in the form of warnings or recalls.

During post-market surveillance, the products shall be sampled and analyzed by the Centre of Quality Control of NPRA.

The samples obtained from post-market surveillance will be subjected to a variety of assessments which include but are not limited to: 

• Identification tests
• Product Composition
• Dissolution 
• Prohibited substances
• Microbial contamination
• Heavy metals

The criteria can be consulted from the "Quality Control Test for Health Supplement Product" section of the Guideline on registration of health supplements.

There is also quality testing for specific ingredients and products: 

• For products containing Aphanizomenon flos-aquae, applicants would have to provide certificates of analysis showing that the microcystin-LR or total microcystins content of the raw material does not exceed 1μg/g and the finished product has been tested for microcystin-LR using an acceptable method.
• For products containing probiotics, applicants are required to provide strain-specific antibiotic resistance data for each probiotic strain.
• For products containing Red Yeast Rice (Monascus purpureus), applicants shall provide certificates of analysis (for both raw material and finished product) showing the Monacolin-K content. The percentage of Monacolin-K shall not exceed 1% and Monakolin-K consumed shall not exceed 10 mg per day.
• Certificate of Analysis for the level of dioxin (PCDDs and PCDFs) and dioxin-like polychlorinated biphenyls (PCBs) is required for product containing ingredient(s) derived from seafood. (The acceptable limit for these tests shall follow standard references such as United States Pharmacopoeia (USP) and European Regulation.) 
• A certificate of Analysis for proof of hormone-free is required for products containing placenta.

[1][2][3]

7.5 Other Notes or Requirements for Importation

Import permit to be registered with the NPRA. 

Cost:  RM 500              

Timeline: Not more than 1 month

Validity: 1 year 

[4]

7.6 Overview Flowchart for Importation Process

Refer to Section 7.6 in “7.0 Importation Requirements" of the "General Foods" guidebook.

7.7 References