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Malaysia

Classification

Health supplements are defined in the Drug Registration Guidance Document (DRGD)[1].

A Health Supplement (HS) means any product that is used to supplement a diet and to maintain, enhance and improve the health function of human body. It is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder, liquids and shall not include any sterile preparations (i.e. injectables, eyedrops). It may contain one or more, or the following combination:

i)       Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;

ii)       Substances derived fromnatural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite;

iii)      Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where the safety of these has been proven.

The following dosage forms are allowed for health supplements:

i) Tablets; Caplet, Lozenge, Chewable tablet, Dispersible tablet, Effervescence tablet, uncoated tablet, enteric coated tablet, Sugar coated tablet, Film coated tablet, extended release tablet;

ii) Capsules; Soft capsule, Hard capsule, Enteric coated capsule, Chewable soft capsule, Extended released capsule;

iii) Powder/ Granules;

iv) Liquid; Emulsion, syrup, spray, suspension.

Other forms may be allowed when supported by an established reference (e.g. Standard Pharmacopeia). For each different dosage form a separate registration is required.

Note that health supplements containing plant substances not commonly consumed as food or used as food ingredients will be regarded as traditional products instead. This applies to food supplements containing Spirulina, Chlorella, Royal Jelly, Bee Pollen, Aloe Vera juice, Noni juice, Extract of chicken with herbs.[2] More information on the registration of natural products can be found in Appendix 5 of the DRGD. The strict separation between health supplements and traditional preparation makes that aplants, animal parts or mineral substances of natural origin combined with vitamins and amino acidsmay not be available forregistration.

In case the manufacturer is uncertain about classification of the concerned product, an application for classification can be submitted with the National Pharmaceutical Control Bureau (Subdivision of the National Pharmaceutical Regulatory Agency).[3]

Registration

-   Type of registration

Health supplements[4]and traditionalproducts require registration as pharmaceutical products/registered drugs with the National Pharmaceutical Regulatory Agency (NPRA).The DRGD defines that food[5] and sports nutrition[6] do not require registration.

-   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.

-   Procedure

Submissions needs to be done online via Quest[7] 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.

Type of evaluation

General or Nutritional Claims

Abridged Evaluation

Functional Claims (Medium)

Abridged Evaluation

Disease Risk Reduction Claims (High)

Full Evaluation

See appendix 2 of the DRGD on the requirements for product registration which clarifies the documentation necessary for either a Full Evaluation or an Abridged Evaluation. The data will be kept confidential. Specific requirements for the registration of health supplements can be found under Appendix 4. A checklist of the dossier requirements is attached (‘attachment 1’ to Appendix 4 of the DRGD).

See the DRGD for specific procedural rules on the registration of products containing glucosamine, Chondroitin and MSM.

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

Timeline

Natural Products

a) Single active ingredient

b) Two (2) or more active ingredients  

a) 116 working days

b) 136 working days

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)

a) 116 working days

b) 136 working days

c) 245 working days

-   Payment

Fees apply for the registration of a product, but also for the membership to Quest (online registration), fordistribution licenses (manufacturer, import, wholesale), modifications to the registration, the issuing of certificates and the request of a product classification. The applicable fees can be found in Appendix 1 to the Drug Registration Guidance Document (DRGD). Listed here are the applicable fees for the registration of health supplements or natural products. Foreign currencies are not accepted.

Category of Product

* Processing Fees

Analysis Fees

Total Fees

Pharmaceutical

a) Generic (Scheduled Poison)

b) Generic (Non-Scheduled Poison)

c) Health supplement

RM 1,000.00

Single active ingredient :

RM 1,200.00

RM 2,200.00

Two or more active ingredients: RM 2,000.00

RM 3,000.00

Natural Product

RM 500.00

RM 700.00

RM 1,200.00

New Chemical entity

RM 1,000.00

Single active ingredient :

RM 1,200.00

RM 4,000.00

Two or more active ingredients :

RM 4,000.00

RM 5,000.00

In order to confirm payment, the applicant shall submit two (2) copies of printed payment voucher together with appropriate fees to the Finance Department of the NPRA. A product reference number shall be given to the application upon payment confirmation.

Payment has to be made within thirty (30) days from the date of approval for screening. The application form will be deleted from the system if payment has not been made within this stipulated time.

-   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.

-   Modifications

Extensive guidance existson the modification of certain particulars in the registration of a health supplement/natural product (e.g. changes to the label).[8]All changes require approval from the NPRA. Note that changes to the active substance may require a new application.

Convenience packs, holding different registered products, require an application for a convenient pack which is considered a variation to an existing registration. The convenient pack label shall contain the same information as in the primary label.

Composition

A.    NUTRIENTS

A list of active ingredients including nutrients, plants and other substances can be consulted on the NPRA website (via this link).[9][N1] New health supplements/active substances can be forwarded on the basis of additional data in the health supplement registration (See table 6 of Appendix 4 DRGD).

Maximum levels for vitamins and minerals can be consulted in Appendix 4 (Point 4.3) of the DRGD. Note that Vitamin K may not be used a single compound in a food supplement. The use of any form of fluoride is not permitted.

B.    PLANTS

Plants are included on the list of active substances together with nutrients and other substances.

C.    OTHER SUBSTANCES

Other substances are included in the list of active substances together with nutrients and other substances.

D.    ADDITIVES AND EXCIPIENTS

As for nutrients, plants and other substances there is a list for authorized additives (link)[N2] [10]

Labelling

-          General labelling

The general labelling requirements, consumer medication information and substance specific labelling requirements are set under Appendix 9 of the DRGD. The requirements are subdivided in  (A) General Labelling Requirements and (B) Specific Labelling Requirements. Appendix 4 includes a mock label with specific comments. In addition, it is required that the product name, name and strength of the active ingredient must be printed repeatedly on the blister/strip.

The General Mandatory particulars are divided over (i) the outer carton, (ii) immediate labels and (iii) blisters and strips. The table indicating the required information for which part of the packaging is copied here below.

Table 1 of Appendix 9 DRGD .

Labels should contain the mandatory information in Bahasa Malaysia or English. Other languages may be present as well. For multi-vitamin and mineral preparations, it is recommended to label as ‘multi-vitamins and minerals’.

A nutrition declaration providing the amounts of energy, carbohydrate, protein and fat is not allowed on the label of health supplements. Neither is the mention of the website for promotional purposes. The use of QR codes is neither allowed, except for the purpose of monitoring inventory.

The labels of products with different strength or different active ingredients should be different. Different sizes of a product may have the same artwork.

The registration should be printed on the product and may not be printed on a stick-on label.

-          Specific warnings:

o   The label of products presented as soft gel with tail (dosage form) shall include the following statement; ‘Under parent supervision’

o   Products with substance from animal origin shall display ‘This product contains substance(s) from animal origin.’

o   Products with porcine shall display ‘This product contains animal part(s) (porcine/pig)

o   Products with a disease risk reduction claim shall include ‘Please consult a doctor/ pharmacist before taking this product.’

Furthermore, a list of substances with specific labelling requirements (warnings) is included in Appendix 9, Tables 4 and 5. Some are drug specific, alimited list of those relevant to food supplements is provided here.

SUBSTANCE

WARNING

ALFALFA (MEDICAGO SATIVA)

-

The warning should be provided in a box.

This product contains Alfalfa (Medico sativa).

Individual with a predisposition to systemic lupus erythematosus should consult their physician before consuming this product.

ARGININE

-

The following statement shall be included on the labels and in the package inserts of oral preparations containing Arginine for health supplement products:

 

WARNING

Arginine is not recommended for patients following a heart attack.

ASPARTAME

Unsuitable for phenylketonurics.

BEE POLLEN

-

The following statement shall be included on the labels and in the package inserts of product containing bee pollen:

This product contains Bee Pollen and may cause severe allergic reactions, including fatal anaphylactic reactions in susceptible individuals.

 

Asthma and allergy sufferers may be at greater risks.

BLACK COHOSH (CIMICIFUGA RACEMOSA) -

The following statement shall be included on the labels and in the package inserts of products containing Black Cohosh (Cimicifuga Racemosa):

WARNING

Stop taking this product if signs and symptoms suggestive of liver injury develop such as tiredness, loss of appetite, yellowing of the skin and eyes or severe upper stomach pain with nausea and vomiting or dark urine and consult your doctor immediately.

Patients using herbal medicinal products should tell their doctor about it.

BOSWELLIA SERRATA

-

The following statement shall be included on label and package inserts of health supplement products containing Boswellia serrata:

WARNING:

Please consult your doctor/pharmacist before using this product if you are on other medicines.

GINKGO BILOBA/ GINKGO EXTRACT

-

The following statements shall be included on the labels and in the package inserts of products containing Gingko biloba/ Gingko extract:

As the use of Ginkgo may increase the tendency of bleeding, please consult your physician/ pharmacist if you are on or intend to start using any other medicines and before you undergo any surgical/dental procedure.

GINSENG

-

The following statements shall be included on the labels and in the package inserts of products containing Ginseng (including all Panax genus):

·         Contraindicated in pregnant women.

·         Safe use in lactating women and children has not been established.

·         Do not exceed the stated dose.

·         Safety on long term use has not been established.

Vitamin K

-

The following statement shall be included in the label and package insert of health supplement products containing Vitamin K as combined ingredients with other vitamins and minerals in oral preparation:

‘Consult a healthcare practitioner if you are on anticoagulant/ blood thinner products.’

 

-          Package insert

The use of a package insert (leaflet) is voluntary. When provided it should include the following particulars:

 (i) Brand or Product Name

(ii) Name and Strength of Active Substance(s)

(iii) Product Description

(iv) Indication

(v) Dose/Use Instruction

(vi) Contraindications

(vii) Warnings and Precautions

(viii) Interactions with Other Medications

(ix) Statement on usage during pregnancy and lactation

(x) Adverse Effects/ Undesirable Effects

(xi) Overdose and Treatment

(xii) Storage Conditions (may be omitted if the information is stated on the label or outer carton labels)

(xiii) Dosage Forms and packaging available

(xiv) Name and Address of manufacturer/ product registration holder

(xv) Date of Revision of Package Insert

-          Prohibited visuals/graphics on the label

See table 13 under Appendix 4 of the DRGD which contains a list of marketing statements and images that are not allowed on the label of health supplements. It is indicated however that this list is not exhaustive and the authority may refuse any other statements, pictures or graphics.

e.g.: ‘money back guarantee’, promotion of other products, consumer testimonials, certification logos (ISO, GMP, HACCP), patent-claims.. etc. 

Packaging

The DRGD contains the following requirements regarding the packaging of health supplements;

i)       The packaging content oftablets, pills, capsules should not exceed 6 months usage, based on the daily dosage

ii)       The packaging of health supplements with with disease risk reduction claim should not exceed 1 month usage, unless justified.

iii)      The packaging of  softgel supplements with tail (twist and squeeze) shall come with a children proof cap

Claims

The use of claims for health supplements is discussed in Appendix 4 (Point 4.4) of the DRGD.

The following definition is given:

A health supplement claim refers to the beneficial effects of consuming HS to promote good health and well-being (physical and mental) by providing nutrition, enhancing body structure/ function, relieving physiological discomfort and/or reducing the risk of health related conditions or diseases.

Three types of claims are distinguished;

i.        General or Nutritional Claims;

e.g. ‘Supports healthy growth and development’, ‘Nourishes the body’, ‘Relieves general tiredness, weakness’, ‘Helps to maintain good health’,

‘For energy and vitality’, ‘For strengthening the body

ii.        Functional Claims (medium);

e.g. ‘Vitamin A helps to maintain growth, vision and tissue development’, ‘Vitamin D helpsin normal development and maintenance of bones and teeth.

iii.       Disease Risk Reduction Claims (high).

e.g. ‘Helps to reduce risk of osteoporosis by strengthening bone’, ‘Helps to reduce the risk of dyslipidaemia’

A list of authorized claims for specific substances is provided in attachment 2 under appendix 4 (Table 19). The inclusion is however does not relief the applicant from the obligation to provide evidence. Neither is the list exhaustive, meaning that other claims will be examined.

In order to make a (i) General or (ii) Functional claim it is required the health supplement contains at least 15% of the Codex Nutrient Reference Values per daily dose for of the vitamin(s) and/or mineral(s). In case of lower amounts, the claim can be used if there is evidence supporting the claim.

The amounts necessary for the use of disease risk claims depends on the substantiating evidence.

Claims should respect the main principles and be supported by adequate evidence. The sources of evidence for each type of claim are listed in the tables 1-3 under Point 4.4.2 of Appendix 4 of the DRGD.An illustrative list of reference texts, originations and regulatory authorities is provided under Point 4.4.4. Table 4 contains the ‘substantiation document’for the information that needs to be submitted in the case of claims are used for the health supplement.

[1] Drug Registration Guidance Document, http://npra.moh.gov.my/en/images/Guidelines_Central/guideline-DRGD/CompleteDRGDwithappendices.pdf,(2016, last revision January 2018).

[2] FAQ : Product Registration, http://npra.moh.gov.my/index.php/product-registration.

[3]Link to form: http://npra.moh.gov.my/images/Application_Form/General_Forms/Borang_300.1_Permohonan_Pengkelasan_Produk_Baru.pdf

[4] For each different dosage form a separate registration is required.

[5] Defined under the Food Act 1983 and Food Regulations 1985

[6]E.g.: body-building products containing protein/ whey/ soya bean

[7] Quest 3, http://npra.moh.gov.my/q3plus/

[8]Malaysian Variation Guideline for natural and health supplement products,http://npra.moh.gov.my/en/images/Guidelines_Central/Guidelines_on_Regulatory/160727_MVG_TMHS_FORM.pdf

2016.

[9]List of active ingredients in health supplements, http://npra.moh.gov.my/en/images/Guidelines_Central/Guideline-health-supplement/Health_Supplement_Active_ingredient_List_2016.pdf (2016).

[10]List of excipients in health supplements, http://npra.moh.gov.my/en/images/Guidelines_Central/Guideline-health-supplement/Health_Supplement_Excipient_ingredient_List_2016.pdf, (2016).

 [N1]Link removed

 [N2]Link removed