II. REGISTRATION OF HEALTH SUPPLEMENTS IN MALAYSIA
(i) Type of registration
Health supplements and traditional products require registration as pharmaceutical products/registered drugs with the National Pharmaceutical Regulatory Agency (NPRA).
(ii) Applicant
The applicant, or Product Registration Holder (PRH), needs to be a locally incorporated company registered with Companies Commission of Malaysia and having a business scope related to health/pharmaceutical products. The local agent will be the holder of the registration certificate and is responsible for all matters in relation to the registered product.
(iii) Procedure
Submissions needs to be done online via Quest on the National Pharmaceutical Regulatory Agency website. All data and information including supporting documents for product registration such as certificates, letters and product labels shall be in English or Bahasa Malaysia.
The registration procedure exists of either a ‘full evaluation’ or an ‘abridged evaluation’ depending on the claims made for the health supplement.
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Type of evaluation
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General or Nutritional Claims
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Abridged Evaluation
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Functional Claims (Medium)
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Abridged Evaluation
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Disease Risk Reduction Claims (High)
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Full Evaluation
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The following timeframes apply for the evaluation of health supplements and natural products. To be calculated from the date of final submission of the application.
Category
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Timeline
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Natural Products
a) Single active ingredient
b) Two (2) or more active ingredients
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a) 116 working days
b) 136 working days
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Health Supplements
a) ** Single active ingredient
b) ** Two (2) or more active ingredients
** Applicable for:
i) General or Nutritional Claims; and
ii) Functional Claims (Medium Claims)
c) Disease Risk Reduction Claims
(High Claims)
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a) 116 working days
b) 136 working days
c) 245 working days
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(iv) Payment
Fees apply for the registration of a product, but also for the membership to Quest (online registration), for distribution licenses (manufacturer, import, wholesale), modifications to the registration, the issuing of certificates and the request of a product classification.
(v) Outcome
If the evaluation is positive a registration number will be awarded (MAL number). The registration remains valid for a period of 5 years. Applicants needs to comply with the conditions imposed upon approval and are responsible for the maintenance of the product in terms of quality, safety and efficacy throughout the validity period of registration. The applicant needs to submit re-registration within the six months prior to expiry through the submission of the Re-registration Application Form and the payment of a processing fee. Failing to do so will result in the need for a new registration satisfying all the procedural requirements.
In case of rejection, an appeal can be brought with the Ministry of Health within 14 days from the date of the notification of the Authority. Re-submission of a rejected application shall not be allowed for 2 years after the rejection. However, if the product is registered in the reference countries, submission of application can be made earlier.
(vi) Modifications
Extensive guidance exists on the modification of certain particulars in the registration of a health supplement/natural product (e.g. changes to the label). All changes require approval from the NPRA. Changes to the active substance may require a new application.