Health Supplement

BiotechCorp Version 1.0 Guidelines on Registration of Traditional & Health Supplement Products Dated 1

st Dec 2011

MALAYSIAN BIOTECHNOLOGY CORPORATION SDN BHD

(Company No. 691431-D)

GUIDELINES ON REGISTRATION OF TRADITIONAL AND HEALTH

SUPPLEMENT PRODUCTS

<GP/BOD/OPERATIONSERVICES/REG001>

Dec 2011 Revision

AUTHORS: ROZITA ISHAK

JUNAINAH MOHAMAD

Please note that the information contained herein is intended to be used for guidance and knowledge only. Whilst every effort has been taken to ensure the accuracy and completeness of the contents at

the time this Guidance Paper is issued, inaccuracies may exist due to several reasons including changes of circumstances and/or amendments brought about due to a change in the policy (s) or

prevailing rules or regulation.

BiotechCorp does not hold out, warrant or guarantee that the reliance on the information contained herein will result in the granting or approval of the matters applied for. BiotechCorp welcomes

feedback and comments on this document Feedback and comments can be sent to [email protected] and by stating clearly in the subject line the document title and document

Reference No.

mailto:[email protected]


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Table of Contents Pages 1 OBJECTIVE AND INTRODUCTION ................................................................................ 1

1.1 Objectives ....................................................................................................................... 1

1.2 Introduction .................................................................................................................... 1

2 OVERVIEW ON REGISTRATION OF TRADITIONAL & HEALTH SUPPLEMENT

PRODUCTS ..................................................................................................................... 1

2.1 What is traditional product .............................................................................................. 1

2.2 What is health supplement product ................................................................................. 2

2.3 What is homeopathy product………………………………………………………….. 2

2.4 Acceptable Claims for traditional & health Supplement product ................................... 2

3 GUIDELINES ON REGISTRATION OF TRADITIONAL & HEALTH SUPPLEMENT....... 2

3.1 Who can apply for product registration ........................................................................... 2

3.2 Quest3 Online Submission System ................................................................................. 2

3.3 How to register the traditional & health supplement product ......................................... 3

3.4 Product Validation ........................................................................................................... 3

3.5 Admin Information .......................................................................................................... 3

3.6 Application Fee ............................................................................................................... 3

4 SAMPLE SUBMISSION................................................................................................... 4

4.1 What are Import Permit and Exemption for Manufacturing and how to apply .............. 4

4.2 Documents required for submission of sample for analysis ........................................... 4

5 APPROVAL ..................................................................................................................... 5

5.1 Lead time for product registration ................................................................................... 5

5.2 Result of testing ............................................................................................................... 5

5.3 Market Placement ............................................................................................................ 5

ANNEXURE .......................................................................................................................... 7

Annex 1 List of prohibited Botanicals (Herbs and herbal derivatives) ........................... 10

Annex 2 Wildlife whose use is prohibited in traditional medicine ................................. 19

Annex 3 Maximum Daily Levels for Vitamins and Minerals for Adults Allowed in

Health Supplements…………………………………………………………..33

Annex 4 Claims acceptable for Traditional Products ...................................................... 34

Annex 5 Functional Claims acceptable for Health Supplement ...................................... 37

Annex 6 List of Non Permissible Indications for Natural Products……………………...39

Annex 7 Quest3 Online System ...................................................................................... 40

Annex 8 Example of Import Permit and Application Letter of Import Permit ............... 53


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1 OBJECTIVES AND INTRODUCTION

1.1 Objectives

The objective of this Guidance Document is to provide general guidance for the registration of traditional product and health supplement in Malaysia. This Guidance paper should be read inconjunction with the relevant sections of the Drug Registration Guidance Document September 2011 Revision produced by the National Pharmaceutical Control Bureau. In the event of any contradiction between the content of this document and any Guidance Document produced by the National Pharmaceutical Control Bureau or any written law, the latter shall take precedence.

1.2 Introduction

Natural product discovery and commercialization is one of the focus areas in the National Biotechnology Policy – Trust 1: Agricultural Biotechnology Development. One of the requirements prior to the commercialization of natural products is for the product to be registered with National Pharmaceutical Control Bureau.

The National Pharmaceutical Control Bureau (NPCB) is a bureau under the Ministry of Health, Malaysia, in charge of pharmaceutical regulatory matters. The main objective of the NPCB is to ensure the quality, safety and efficacy of products for the local market through a registration and licensing scheme. Products that are regulated by the NPCB include:

Pharmaceuticals;

Traditional and Health Supplements;

Cosmetics; and

Veterinary products. For more information, please log on to http://www.bpfk.gov.my

2 OVERVIEW ON REGISTRATION OF TRADITIONAL & HEALTH SUPPLEMENT PRODUCTS

2.1 What is traditional product?

Traditional product is defined as any product used in the practice of indigenous medicine, in which the drug consists solely of one or more naturally occuring substances of a plant, animal or mineral or part thereof, in the unextracted or crude extract form and a homeopathic medicine. Source : Drug Registration Guidace Document, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Sept 2011Revision

Note however that ingredients that fall under the prohibited plant or animal list are not allowed to be registered.

http://www.bpfk.gov.my/


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Please refer to Annex 1 and Annex 2 for the list of prohibited plants and animals respectively.

2.2 What is health supplement product?

Health supplements shall mean products that are intended to supplement the diet taken by mouth in forms such as pills, capsules, tablets, liquids or powders and not represented as conventional food/sole item of a meal or diet. Health supplements may include ingredients such as vitamins, minerals, amino acids, natural substances of plant/animal origin, enzymes and substances with nutritional or physiological function. Source : Drug Registration Guidace Document, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Sept 2011Revision

The maximum daily levels of vitamins and minerals allowed in health supplement

products for adults are listed in Annex 3. 2.3 What is homeopathy product? Homeopathic medicine means any pharmaceutical dosage form used in the

homeopathic therapeutic in which diseases are treated by use of minute amounts of such substances which are capable of producing in healthy persons symptoms similar to those of disease being treated. (Control of Drugs and Cosmetics Regulation 1984)

2.4 Acceptable Claims for traditional and health supplement product.

For traditional products, the words “Traditionally used for” must be inserted in

front of the claim. The claims allowed for traditional products are listed in Annex 4. The functional claims acceptable for health supplements are dependent on the vitamin and mineral content of the product. The indication allowed for health supplements are; used as health supplement, dietary supplement, food supplement or nutritional supplement. The indication for pregnant and lactating women would be “vitamin and mineral supplements for pregnant and lactating women”.

Functional claims acceptable for health supplement products are listed in Annex

5. List of non permissible indications for natural products are listed in Annex 6.

3 GUIDELINES ON REGISTRATION OF TRADITIONAL & HEALTH SUPPLEMENT

3.1 Who can apply for product registration?

The applicant for product registration must be registered with Suruhanjaya Syarikat Malaysia (SSM) or Malaysia Registrar of Business (ROB). If the applicant is not the product owner, it should be authorized in writing by the


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product owner to be the holder of the product registration certificate and be responsible for all matters pertaining to the registration of the product.

3.2 Quest3 Online System

The application for product registration must be submitted via online at http://www.bpfk.gov.my

3.2.1 What is the Quest3 Online Submission System?

The Quest3 system is a new enhanced online system to replaced Quest2 system. It is an integrated and computerized system used by the National Pharmaceutical Control Bureau which enables the Product License Holder, Manufacturer, Importer and other related users to conduct a secured online transaction for the purpose of product registration, renewal of registration, change of manufacturing site and for application for variation of product particulars such as labelling, packaging sizes and claims.

To access this system, you are required to have a User Digital Certificate which

comes in a Smart Card System. There are 2 categories of Quest3 users; i) First time user ii) Existing Quest2 user Please refer to Annex 7 on details of how to access the Quest3 system.

3.3 How to register the traditional and health supplement product

The application for product registration follows a 2-step process:

i. Step 1 : Product Validation; and ii. Step 2 :(Part 1) Submission of administration data and product

information.

3.4 Product Validation

All fields in product validation section are compulsory;

I. Product Name

To enter product name, dosage form and strength.

II. Dosage Form

You may select from the given list. A tablet may be plain, chewable, coated (enteric, film, or sugar), dispersible, effervescent, extended release, sublingual, etc.

III. Active Substance

Substance name You may select substance from the search database. If it is not listed, it may be entered manually and will be added onto the list.

Strength of substances



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You may enter the content of active ingredients (numerical) and then select the weights and measures from the given list.

IV. Excipient

To indicate function of substance e.g sweetener, preservative, etc.

V. Any porcine material (Yes / No)

VI. Manufacturer

You may select from the search data base. Details need to be submitted if you are new manufacturer. Please indicate if the manufacturer is a contract manufacturer or otherwise.

VII. Product Classification

The application form displayed at Step 2 will depend on the type of product classification chosen. Traditional and health supplement product will only require to submit information under Part1.

For traditional products, pick from the list displayed; - Traditional - Homeopathy - Dietary supplements / food supplements

3.5 Administrative Data and Product Information Section A: Product Particulars

I. Product description

Briefly state the visual and physical characteristic of the product including the shape, size, colour, odour, taste, consistency, type of table coating, etc.

II. Indication / Usage

Only indication allowed for traditional and health supplement can be made.

III. Dose / Use Instruction

IV. Contraindication

V. Warnings and Precautions

VI. Drug Interactions

VII. Side Effect or Adverse Reactions

VIII. Signs and Symptoms of Overdose and Treatment

IX. Storage Condition


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X. Shelf Life

XI. Therapeutic Code (is any)

Applicants should indicate the WHO assigned ATC code for each distinct therapeutic indication proposed for a product, if such a code is available. Please choose from the list given at database.

Section B: Product Formula

I. Batch Manufacturing Formula

Copy of batch manufacturing formula is required for this section. State the batch size and actual batch manufacturing master formula.

II. Manufacturing process

Briefly describe the manufacturing process starting from the raw material until finished product including the assembling part. If the product is repacked by another manufacturer, details of repacking and the quality control must be supplied.

III. Attachment of In Process Quality Control

Copy of In Process Quality Control during the production including the numbers of sample, frequency of sampling and specification for quality assurance of the product.

IV. Attachment of Finished Product Quality Specification

Provide details of quality control specifications including a list of tests and state the limits of acceptance.

V. Stability Data

Section C: Particulars of Packing

I. C1 : pack size and fill details by weight, volume or quantity II. C2 : container type III. C3 : barcode no IV. C4 : recommended distributor‟s price (not compulsory) V. C5: recommended retail price (not compulsory)

Section D: Label Mock up for Immediate Container, Outer Carton and Proposed Package Insert

I. Attach the mock up label for immediate container, outer carton and proposed package insert if applicable.

In summary, the documents required for this section are:

For Local Products For Imported Products

Batch Manufacturing Formula

In Process Quality Control

Finished Product Specification Stability Data

Batch Manufacturing Formula

In Process Quality Control

Finished Product Specification Stability Data


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All documents should be in JPEG, GIF or PDF format not more than 1MB for each attachment.

3.6 Application Fee

Once the application form has been submitted, you are required to pay the

application fee. In the system, proceed to the Registration Payment section, click “pay” at the bottom of the screen. Select your payment method on the next screen and click “confirm” at the bottom of the screen. The screen will display a payment voucher and click “print” the bottom of the screen.The payment voucher must be attached together with the payment. A copy of the payment voucher is also required during sample submission.

The application fees shall be made payable to “Biro Pengawalan Farmaseutikal

Kebangsaan” in the form of a bank draft or money order . The total fee for traditional product is RM1,200 while for health supplement

productis RM2,200. For a health supplement product containing two or more active ingredients, the fees is RM3,000.

The payments should be sent to: Administrative Unit,

National Pharmaceutical Control Bureau, Jalan Universiti, PO Box 319, 46730 Petaling Jaya Selangor

Evaluation of product information will only start after clearance of payment.

4 SAMPLE SUBMISSION

For traditional products, once the NPCB‟s accessor has completed the product evaluation, a notification e-mail will be sent to you and you are required to submit your sample for laboratory analysis. In doing so, you may need either an import permit (if your product is manufactured outside Malaysia) or exemption for manufacturing of sample (for locally manufactured product).

Label (Mock Up) for immediate Container

Label (Mock Up) for outer Carton

Good Manufacturing Practice Certificate (GMP)

Protocol of Analysis

Certificate of Analysis

Label (Mock Up) for immediate Container

Label (Mock Up) for outer carton

Certificate of Free Sale (CFS)

Good Manufacturing Practice Certificate (GMP)

Letter of Authorisation from Product Owner

Letter of Appointment of Contract Manufacturer from Product Owner

Letter of Acceptance from Contract Manufacturer

Protocol of Analysis



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For health supplements, sample analysis will only be done after product registration has been approved. A letter will be sent to you when you need to submit your sample for laboratory analysis.

4.1 What are Import Permits and Exemption for Manufacturing of Sample and

how to apply?

An import permit is a permit required prior to bringing an unregistered product

into Malaysia as samples for laboratory analysis. The permit will be endorsed by an enforcement officer at the entry point and has to be submitted together with the sample to the Laboratory Services Unit of NPCB. You should write in to apply for the import permit from the Centre of Product Registration, NPCB. Please refer to Annex 8 for an example of import permit.

Exemption for Manufacturing of Sample An exemption for manufacturing of sample is a letter that is required for a

local manufacturer to manufacture an unregistered product for sample submission. It has to be submitted together with the sample to the Laboratory Services Unit of NPCB. The Exemption for Manufacturing of Sample letter will be automatically generated by the system during the process of product registration. You can print out the letter through the Quest3 System after submitting your product registration.

4.2 Documents required for submission of sample for analysis

For Local Products For Imported Products

Exemption for Manufacturing of Sample letter

A minimum quantity of 6 separate containers with total contents of not less than 200gms

Samples must be in their original packaging & labelling


The expiry date of samples must be at least 1 year from the date of submission

A copy of the payment voucher

Sample must be from the same manufacturing premise as stated in the application for registration

Import permit

A minimum quantity of 6 separate containers with total contents of not less than 200gms

Samples must be in their original packaging & labelling


The expiry date of samples must be at least 1 year from the date of submission

A copy of the payment voucher

Sample must be from the same manufacturing premise as stated in the application for registration


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5 APROVAL

5.1 Lead time for product registration

For traditional and health supplement products, the evaluation process generally

takes about 80 working days.

5.2 Result of Testing

The result of testing will be notified via the Quest3 System. 5.3 Market Placement

A product cannot be placed in the market until you get the registration number

which starts with the word „MAL‟. NPCB will inform you (via email) once your product has been approved. The registration number must be printed on your product label before it can be released onto the market.


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Flow chart for the stages of registration under the Quest3 System

Stage 1

Stage 2

Step 1

Step 2

Apply for Digicert Smart Card System (Quest3)

Submit documentation via Quest3 System (online)

Product Validation

Part 1: Submit Administration Data & Product Information

Application Evaluated by the NPCB assessor

Sample Submission

Approval


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Annex 1

List of Prohibited Botanicals (Herbs and herbal derivatives)

(i) Botanicals (and botanicals ingredients) containing scheduled poisons as listed

Under the Poison Act 1952

Aconitum Asidosperma quebracho Asidosperma belladonna Atropa belladona Black nightshade Berberis Calaber bean (physostigma venenosum) Cabola albarrane Chondodendron tomentosum Colchicum autumnale Datura metel Datura stramonium Digitalis purpurea folium Drimia maritime (Squill) Ephedra Herbs Foxglove leaf Gelsemium sempervirens Hyoscyamus muticus Hyoscyamus niger Larrea tridenata Larnea Mekicara Lobelia inflate Lobelia nicotianifolia Mitragyna spesiosa Korth. (mitragynine) Nicotinana Tabacum (solanine) Nux Vomica Papaver somniferum Physostigma microphyllus Puasininystalia yohimbe Rauwolfia serpentine Rauwolfia vomitoria Schoenocaulonofficinale Scillae bulbus (Squill) Solanum nigrum (Black nighshade) Strychnos nuxvomica Urginea maritime (Squill) Urginea Scill (Squill) Velerian extract (valepotriats)


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(ii) Botanicals (& botanical ingredients) which are banned

Reported to cause. Botanical‟s name (& botanical ingredients)

-Liver toxicity

1. Chapparal (Larrea tridentate & Larrea Mexicana) 2. Piper methysticum (kava-kava) 3. Comfrey (Symphytum officinale, S.asperum, S.x.uplandicum) 4. senacio spp (Senecio aureus, S.jacobaea, S.bicolor, S.nemorensisi, S.vulgaris, S.longilobus, S.scandens Buch.-Ham)

-Kidney toxicity

1. Magnolia officinalis 2. Stephania tetrandra 3. Aristolochic Acid (A. A) **to identify the Botanicals which may contain A.A please refer to List A & List B

-Not allowed in preparation for oral use

Dryabalanops aromatic & Borneolum syntheticum (contains camphor & borneol)

-Disturbance of the nervous system

Hydrastis Canadensis


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U. S Food and Drug Administration

Center for Food Safety and Applied Nutrition Office of Nutritional Products, Labelling and

Dietary Supplements

List A Botanicals known or suspected to contain Aristolochic Acid

Botanical Name Common or other names

Aristolochia spp

Aristolochia Guan mu tong Guang mu tong

Aristolochia acuminata Lam Oval leaf

Syn . Aristolochia tagala Champ

Dutchman‟s pipe

Aristolochia Griseb

Aristolochia bracteolate Retz

Ukulwe

Aristolochia chilensis Bridges in Lindl.

Aristolochia cinnabarina C.Y. Cheng & J.L Wu

Aristolochia clematitis L.

Birthwort

Aristolochia contorta Bunge

Ma dou ling Tian xian teng

Aristolochia cymbifera Mart. Zucc.

Mil homes

Aristolochia debilis Siebold & Zucc. Syn. Aristolochia longa Thunb. Syn. Aristolochia recurvilabra Hance

Ma dou ling Tian xian teng Qing mu xiang

Syn. Aristolochia sinarum Lindl.

Sei-mokkou (Japanese) Birthwort Long birthwort

Aristolochia elegans Mast. Syn. Aristolochia hassleriana Chodat

Aristolochia esperanzae Kuntze Aristolochia fangchi Y.C Wu ex L.D. Chow & S.M Hwang

Guang fang ji Fang ji Mokuboi (Japanese) Kwangbanggi (Korean) Fang chi Kou-boui (Japanese)


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Aristolochia fimbriata Cham

Aristolochia indica L.

Indian birthwort

Aristolochia kaempferi Willd. Syn. Aristolochia chrysops (Stapf) E.H Wilson ex Rehder Syn. Aristolochia feddei H. Lév. Syn. Aristolochia heterophylla Hemsl Syn. Aristolochia mollis Dunn Syn. Aristolochia setchuenensis Franch Syn. Aristolochia shimadai Hayata Syn. Aristolochia thibetica Franch Syn. Isotrema chrysops Stapf Syn. Isotrema heterophylla (Hemsl.) Stapf Syn. Isotrema lasiops Stapf

Yellowmouth Dutchman;s pipe

Aristolochia kwangsiensis Chun 7 F.C. How Syn. Aristolochia austroszechuanica C. B Chien & C. Y. Cheng

Aristolochia macrophylla Lam. Syn. Aristolochia siphon L‟Hér.

Dutchman‟s-pipe

Aristolochia manschuriensis Kom. Syn. Hocquartia manshuriensis (Kom.) Nakai Syn. Isotrema manchuriensis (Kom.) H. Huber

Manchurian Birthwort Manchurian Dutchman‟s pipeGuang mu tong Kan-Mokutsu (Japanese) Mokuboi (Japanese) Kwangbanggi (Korean)

Aristolochia maurorum L.

Aristolochia maxima jacq. Syn. Aristolochia maxima var. Angustifolia Duchartre in DC. Syn. Howardia hoffmanni Klotzsch

Aristolochia mollissima Hance

Aristolochia pistolochia L. Aristolochia rigida Duch.

Aristolochia rotunda Linn.

Aristolochia serpentaria L. Syn. Aristolochia serpentaria var. Hastate (Nutt) Duch.

Virginia snakeroot Serpentaria Virginia serpentary

Aristolochia watsoni Wooton & Standley or Aristolochia watsonii Wooton & Standley Syn. Aristolochia porphyropyylla Pfeifer

Aristolochia westlandii Hemsl. Or Aristolochia westlandi Hemsl.


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Aristolochia zollingeriana Miq. Syn. Aristolochia kankauensis Sasaki Syn. Aristolochia roxburghiana subsp. Kankauensis (Sasaki) Kitam. Syn. Hocquartia kankauensis (Sasaki) Nakai ex Masam. Syn. Aristolochia tagala var. Kankauensis (Sasaki) T. Yamaz.

Asarum canadense Linn. Syn. Asarum acuminatum (Ashe) E.P. Bicknell Syn Asarum ambiguum (E.P. Bicknell) Daniels Syn. Asarum canadense var. Ambiguum (E.P. Bicknell) Farw. Syn. Asarum canadense var. Refelxum (E.P. Bicknell) B.L. Rob. Syn. Asarum furcatum Raf. Syn. Asarum medium Raf. Syn. Asarum parvifolium Raf. Syn. Asarum refelxum E.P. Bicknell Syn. Asarum rubrocinctum Peattie

Wild ginger Indian ginger Canada snakeroot Fals coltsfoot Colic root Heart snakeroot Vermont Snakeroot Southern snakeroot

Asarum himalaicum Hook. f. & Thomson ex Klotzsch or Asarum himalaycum Hook. f. & Thomson ex Klotzsch

Tanyou-saishin (Japanese)

Asarum splendens (F. Maek.) C.Y. Cheng & C.S. Yang

Do-saishin (Japanese)

Bragantia wallichii R.Br. Specimen exists at New York Botanical Gardens. Tropicos does not list this species as a synonym for any Thottea species. Kew Gardens Herbarium does not recognize the genera Bragantia. Until additional information is obtained we will use the same name as cited in J. Nat. Products 45:657-666 (1982)


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List B

Botanicals which may be adulterated with Aristolochic Acid

Botanical Name* Common or Other Names

Akebia spp. Akebia Mu tong Ku mu tong Zi mutong Bai mu tong Mokutsu (Japanese) Mokt‟ong (Korean)

Akebia quinata 9Houtt.) Decne Syn. Rajania quinata Houtt.

Chocolate vine Fiveleaf akebia Mu tong Yu zhi zi Mukotsu (Japanese)

Akebia trifoliate (thumb.) Koidz. Mu tong Three leaf akebia Yu zhi zi

Asarum heterotropoides F. Schmidt Syn. Asarum heteropoides F. Schmidt Syn. Asiasarum heterotropoides (F. Schmidt) F. Maek.

Keirin-saishin (Japanese) Chinese wild ginger Manchurian wild ginger Bei xi xin Xin xin

Asarum sieboldii Miq. Syn. Asarum sieboldii fo. Seoulense (Nakai) C.Y. Cheng & C.S Yang Syn. Asarum sieboldii. var. Seoulense Nakai Syn. Asiasarum heterotropoides var. Seoulense (Nakai) F. Maek. Syn. Asiasarum sieboldii (miq) F. Maek.

Usuba-saishin (Japanese) Chinese wild ginger Xi Xin Hua Xi Xin Manchurian wild ginger Siebold‟s wild ginger

Clematis spp. Clematis Mufangji Clematidis Ireisen (Japanese) Wojoksum (Korean)

Clematis armandii Franch. Syn. Clematis armandii fo. farquhariana ( W.T. Wang) Rehder & E.H. Wilson Syn. Clematis armandii var. biondiana (Pavol) Rehder Syn. Clematis biondiata Pavol Syn. Clematis ornithopus Ulbr.

Armand‟s clematis Chuan mu tong (stem) Xiao mu tong Armand‟s virgin bower

Clematis chinensis Osbeck.

Chinese clematis Wei ling xian (root)

Clematis hexapetala Pall.


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Clematis montana Buch.-Ham. Ex DC. Syn. Clematis insulari-alpina Hayata

Clematis uncinata Champ. Ex Benth. Syn. Clematis alsomitrifolia Hayata Syn. Clematis chinensis var. uncinata (Champ. Ex benth.) Kuntze Syn. Clematis drakeana H. Lév. & Vaniot Syn. Clematis floribunda (Hayata) Yamam Syn. Clematis gagnepainiana H.Lév. & Vaniot Syn. Clematis leiocarpa Oliv. Syn. Clematis ovatifolia T. Ito ex Maxim. Syn. Clematis uncinata var. biternata W.T.Wang Syn. Clematis uncinata var. coriacea Pamp. Syn. Clematis uncinata var. Floribunda Hayata. Syn. Clematis uncinata var. ovatifolia (T. Ito ex Maxim.) Ohwi ex Tamura Syn. Clematis uncinata var. taitongensis Y.C. Liu 7 C.H. Ou

Cocculus spp. Cocculus carolinus (l.) DC. Syn. Cebatha carolina Britton Syn. Epibaterium carolinum (L.) Britton Syn. Menispermum carolinum L.

Cocculus

Cocculus diversifolius DC. Syn. Cocculus madagascariensis Diels

Coccolus hirsutus (L.) Diels Syn. Cocculus villosus DC. Syn. Menispermum hirsutum L.

Cocculus indicus Royle Syn. Anamirta paniculata Colebr.

Indian cockle

Cocculus laurifolius DC. Syn. Cinnamomum esquirolii H. Lév. Cocculus leaebe DC.

Cocculus madagascariensis Diels Syn. Cocculus diversifolius DC.


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Cocculus orbiculatus DC. Syn. Cissampelos pareira Linn. Cocculus orbiculatus (L.) DC. Syn. Cocculus cuneatus Benth. Syn. Cocculus sarmentosus (Lour.) Diels Syn. Cocculus sarmentosus var. linearis Yamam. Syn. Cocculus sarmentosus var. pauciflorus Y.C. Wu Syn. Cocculus sarmentosus var. stenophyllus Merr. Syn. Cocculus thunbergii DC. Syn. Cocculus trilobus (Thunb.) DC. Syn. Menispermum orbiculatus L. Syn. Menispermum trilobum Thunb. Syn. Nephroia sarmentosa lour.

Moku-boui (Japanese)

Cocculus palmatus (Lam.) DC.

Columba Columbo

Cocculus pendulus Diels Syn. Cebatha pendua (J.R. & C. Forst.) Kuntze Syn. Epibaterium pendulus Forst. f. Syn. Cocculus Epibaterium DC.

Cocclulus pendulus (Forst. & Forst) Diels.

Cocculus palmatus Hook. Syn. Jateorhiza Miersii Oliver

Cocombo

Cocculus thunbergii DC.

Diploclisia affinis (Oliv.) Diels. Syn. Diploclisia chinensis Merr. Syn. Cocculus affinis Oliv.

Diploclisia chinensis Merrill

Xiangfangchi

Manispernum dauricum

Saussurea lappa (Decne.) Sch. Bip.

Mokkou (Japanese)


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Sinomenium acutum (Thunb.) Rehder & E.H. Wilson Syn. Cocculus diversifolius var. cinereus Diels Syn. Cocculus heterophyllus hemsl. & E.H. Wilson Syn. Menispermum acutum Thunb. Syn. Sinomenium acutum (Thunb.) Rehder & E.H. Wilson Var. cenereum (Diels) Rehder & E,H. Wilson Syn. Sinomenium diversifolium (Diels) Diels

Orientvine Xunfengteng Dafengteng Daqingmuxinag Zhuigusan Da ye qingshener Mufangji Hanfangji Tuteng Zhuigufeng Maofangji

Stephania spp.

Stephania

Stephnia tetrandra S.Moore Vladimiria souliei (franch) Ling

Fen fsng ji, fang ji Fang ji (root) Hang fang ji Kanboi (Japanese) Hanbanggi (Korean) Fun-boui (Japanese) Sen-mokkou


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Annex 2

Wildlife whose use is prohibited in traditional medicines.

Traditional products are prohibited from containing ingredient derived from the body / parts of wildlife as listed in the Wildlife Protection Act 1972. Some examples of the animals and birds whose use is prohibited have been listed as examples below. For full list of the prohibited wildlife, please refer to the Wildlife Protection Act 1972. FIRST SCHEDUL COMPLETELY PROTECTED WILDLIFE SPECIES

No English Name Scientific Name Malay Name

1 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.

Javan Rhinoceros Sumatran Rhinoceros Tapir Banteng Siamang Agile Gibbon White-handed Gibbon Scaly anteater or Pangolin Malayan wild Dog Clouded Leopard Marbled Cat Flat-headed Cat Golden Cat Linsang Binturong or Bear-cat Slow Loris Otter civet Derby‟s Banded Civet

Rhinoceros sondaicus Didermocerus sumatrensis

Tapirus Indicus

Bos banteng Hylobates syndactylus Hylobates agilis Hylobates lar Manis javanica Cuon alpines Neofelis nebulosa Felis marmorata Felis planiceps Felis temminckii Prionodon linsang Artictis binturong Nyticebus caucang Cynogale bennettii

Hemigalus derbyanus

Badak Raya Badak Kerbau

Badak Chipan, Badak Tampong Banteng, Sapi, hutan Siamang Wak-wak Ungka Tenggiling Serigala, Anjing hutan Harimau dahan Kucing dahan Kucing hutan Kucing tulip Linsang Binturong Kongkang, kera duku Musang memerang Musang belang


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19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34.

Yellow-throated Marten

Weasel Long-tailed porcupine Serow Selangor Pigmy Flying Squirrel Red-cheeked Flying Squirrel Grev-cheeked Dlying Whiskered Flying squirrel White-Bellied Flying Vordemann‟s Flying Horsfield‟s Flying Squirrel Smoky Flying squirrel Large Black Flying Squirrel Red Giant Flying Squirrel Spotted Giant Flying Malayan Flying Lemur

Martes flavigula Mustela nudipes Trichys lipura Capricornis sumatrensis Petaurillus kinlochii Hylopetes spadiceus Hylopetes Lepidus Petinomys genebarbis Petinomys setosus Petinomys vordermanni Lomys horsfieldii Pteromyscus pulverulentus

Aeromys tephromelas Petaurista Petautista Petaurista elegant Cynocephalus

Mengkira Pulasna Landak padi Kambing gurun, Tupai terbang terkecil Tupai terbang pipi merah Tupai terbang squirrel pipi kelabu Tupai terbang berjambang

Tupai terbang squirrel dada putih Tupai terbang squirrel kecil

Tupai terbang ekor merah Tupai terbang kotor

Tupai terbang hitam Tupai terbang merah

Tupai terbang squirrel bintang

Kubong


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SECOND SCHEDULE PROTECT WILDLIFE SPESIES

Part I : Binatang-binatang Perburuan besar (Large hunted animals)

No English Name Scientific Name Malay Name

1. 2.

Elephant Gaur

Elephas maximus Bos gaurus hubbacki

Gajah Seladang

Part II : Binatang-binatang perburuan ( Prey animals)

1. 2. 3. 4. 5. 6. 7. 8. 9.

Sambur Deer Barking Deer Large Muose-Deer Lesser Muose-Deer Tiger Leopard Malayan Honey-Bear Wild pig Bearded pig

Cervus unicolor equines Munctiacus muntjak Tragulus napu Tragulus javanicus Pantheratigris Panthera pardus Helarctos malayanus Sus scrofa Sus barbatus

Rusa Kijang Napoh Pelandok Harimau belang Harimau bintang, Harimau kumbang Beruang Babi hutan Babi bodoh

Part III : Binatang-binatang liar lain yang diperlindungi (Other protected wildlife)

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.

Hairy-nosed Otter Smooth Otter Common Otter Small-clawed Otter Common Palm Civet Malay Civet Short-tailed Mongoose Small Indian Mongoose Indian Grey Mongoose Leopard Cat Pig-tailed Macaque Malayan Porcupine Malayan Flying Fox Crocodile Python Water monitor Clouded monitor Dumeril‟s Monitor

Lutra sumatrana Lutra perspillata Lutra lutra Amblonyx cinerea Paradoxurus hermaphrodites Viverra tangalunga Herpestes branchyurus Herpeteses auropunctatus Herpestes edwardsii Felis bengalensis Macaca nemesrina Hystrix brachyuran Pteropus vampyrus Crocodylus porosus Python reticulates Varanus salvator Veranus nebulosus Varanus dumeril

Memerang hidung Memerang licin Memerang utara Memerang kecil Musang pulut

Musang tenggalong Bambun ekor pendek Cheperlai,bambun kecil

Bambun kelabu Kucing Batu Berok Landak raya Kluang Buaya Tembaga Ular Sawa Biawak air Biawak tikus Biawak kudong


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THIRD SCHEDULE COMPLETELY PROTECTED WILD BIRDS

No Name Family English Name Scientific Name Malay

Name

1. Grebes Podicipididae -Little Grebe -Podiceps ruficollis

2.

Petrels

Hydrobatidae

-Wilson‟s Storm Petrel

-Oceanitis Occeanicus

3.

Tropic Birds

Phaethontidae

-Short-tailed Tropic Bird

-Phaeton aethereus

4.

Pelicans

Pelecanidae

-White Pelcian

-Pelecanus onocrotalus

-Undan Putih

5.

Grannets & boobies

Sulidae

-Brown booby

-Sula leocogaster

-Dendang laut

6.

Cormorants

Phalacrocoracidae

-Common Cormorant

-Phalcrocorax carbo

-Dendang air

7. Darters Anhingidae -Darter -Anhinga anhinga -Burung kosa

8.

Frigate Birds

Fregatidae

-Christmas Island Frigate-bird

-Fregata andrewsi

-Burung Simbang Pulau

9.

Herons

Ardeidae

-Dusky-grey Heron -Cattle Egret -Chinese Egret -Night Heron -Cinnamon Bittern

-Ardae sumantrana -Bubulcus ibis -Egreetta eulophotes -Nycticorax nycticorax -Ixobrychus eurhythmus

-Burung Lembu -Burung Bangau Burung Bangau China -Burung kuak -Puchong Bendang

10.

Stork Ciconiidae

-Milky Stork -Storm‟s Stork -Lesser Adjuntant Stork

-Ibis lcinereus -Ciconia stormi -Leptoptilos javanicus

-Burung Upeh -Burung Botak

11. Ibises Threskiornithidae -White Ibis

-Threskiornis aethiopica

-Burung Sekendi


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12. Hawks and Eagles

Accipitridae -Bat Hawk -Crested Honey Buzzard -Black Eagle -King Vulture -Long-billed Vulture -White-backed Vulture -Marsh Harrier -Short-toed Eagle

-Machaerhamphus alcinus -Pernis ptilorhynchus -Ictinaetus malayensis -Torgos calvus -Gyps indicus -Pseudogyps bengalensis -Circus aeruginosus -Circaetus gallicus

-Lang Malam -Lang Lebah -Lang Hitam -Burung Hereng -Burung Hereng Paroh Panjang -Burung Hereng Belakang Putih -Lang Kepala Putih -Lang Jari Pendek

13. Osprey Pandionidae -Osprey -Pandion haliaetus -Lang Tiram

14. Falcons Falconidae -Red-breasted Falconet -Peregrine Falcon -Kestrel

-Microhierex caerulescens -Falco peregrines -Falco tinnunculus

-Lang Rajawali

15.

Pheasants, partidges

Phansianidae -Long-billed Partridge -Black Wood Partridge -Roulroul -Chestnut-breasted Partridge -Malay Peacock Pheasant -Rothschild‟s -Great Argus -Green Peafowl

-Rhizothera longirostris -Melanoperdix nigra -Rollulus roulroul -Arborophilia charlaeni -Polyplectron Malacensis -Rheinartia Ocellata -Agusianus argus -Pavo muticus

-Burung Selanting -Burung Bertam -Burung Siul -Sang Serok -Merak Pongsu -Kuang Raya Gunung -Kuang Raya -Merak

16. Cranes Gruidae -Eastern Sarus Crane

-Grus antigone -Burung Keria


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17.

Rails, Crakes & gallinules

Rallidae -Purple Coot -Masket Finfoot

-Porphyrio Porphyria -Heliopais personata

-Panglin -Burung Pedendeng

18.

Jacanas

Jacanidae

-Pheasant-tailed Jacana -Bronze-weiged Jacana

-Hydrophasianus Chirurgus -Metopidius indicus

-Burung Teratai

19.

Gulls & terns

Laridae -White-winged Black Tern -Common Tern -Roseate Tern -Little Tern -Crested Tern -Common Noddy

-Chlidonias leucoptera -Sterna hirundo -Sterna doughalli -Sterna albifrons -Sterna bergii -Anous stolidus

-Chamar Sayap Putih -Chamar -Chamar Jambu -Chamar Kecil Chamar Berjambul -Chamar Hitam

20. Pigeons & Doves

Columbidae -Nicobar pigeon -Pied Imperial Pigeon -Mountain Imperial Pigeon -Red Turtle Dove

-Coloenas nicobarica -Ducula bicolour -Ducula badia -Streptopelia tranquebarica

-Merpati Mas -Rawa -Pergam Bukit

21. Cukcoos Cuculidae -Lesser Hawk Cuckoo -Hawk Cuckoo -Banded Bay Cukcoo -Koel -Lesser Green-billed Malcoha -Large Green-billed Malcoha -Raffles‟s Malcoha

-Cuculus vagans -Cuculus fugax -Cacomantis sonnerati -Eudvnamis scolopacea -Phaenicophaeus diardi -Phaenicophaeus tristis -Phaenicophaeus chlorophaeus

-Sewah tekukor -Sewah tekukor Besar -Burung Takuweh -Burung Tahu -Burung Chenok -Burung Kera -Burung Krak


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22. Typical owls Strigidae -Collared Scops Owl -Scops Owl -Reddish Scops Owl -Malay Eagle Owl -Fish Owl -Pygmy Owlet -Spotted Wood Owl

-Otus bakkamoena -Otus scops -Otus rufescens -Bubo sumatranus -Bubo ketupu -Glaucidium brodiei -Strix seluputo

-Burung Jampok -Burung Hantu -Burung Punggok Kechil -Burung Charek-kafan

23. Barn Owls Tytonidae -Barn Owl -Bay Owl

-Burung Punggok Api

24. 25.

Frogmounths Nightjars

Podargidae Carprimulgidae

-Large Frogmouth -Blyth‟s Frogmouth -Malaysian Eared Nightjar -Long-tailed Nightjar -Migratory Nightjar

-Batracostomus auritus -Batrachostomus affinis -Eurostopodus temmincki -Caprimulgus macrurus -Caprimulgus indicus

-Burung Segan -Burung Taptibau -Burung Kuber -

26. Swifts Apodidae -Giant Swiftlet -Grey-rumped Swiftlet -White-bellied Swiftlet -Malaysian Spinetail Swift -Migrant Swift

-Collocalia gigas -Collocalia fuciphaga -Collocalia esculenta -Chaetura gigantean -Apus pacificus

- -Layang-layang Gua -Layang padi -Layang-layang besar

27. Tree Swift Hemiprocnidae -Crested Tree Swift -White-whiskered Tree Swift

-Hemiprocne longipennis -Hemiprocne comate

-Layang-layang Berjambol

28. Trogons Trogonidae -Red-naped Trogan -Diard‟s Tragon -Orange-breasted Trogon

-Harpactes kasumba -Harpactes Trogon -Harpacted oreskios

-Burung Kesumba -Burung Gembala Rimau


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29. Kingfishers Alcedinidae -Common Kingfisher -Blue-banded Kingfisher -Brown-winged Stork-billed Kingfisher -White-collared Kingfisher

-Alcedo atthis -Alcedo auryzona -pelargopsis amauroptera -Halcyon concreata

-Pekaka Chitchit -Pakaka Bukit -Burung Buaya -Raja Udang

30. Bee-eaters Meropidae -Bay-haeaded Bee-eater -Blue-throated Bee-eater

-Merops leschenaulti -Merops viridis

-Berek-berek -Rengkok Biru

31. Rollers Crocidae -Burmese Roller -Broad-billed Roller

-Coracias benghalensis -Eyrystomus orientalis

-Tiong Batu

31. Hoopoe Upupide -Hoopoe -Upupa epops

32. Hornbills Bucerotidae -White-crested Hornbill -Bushy-crested Hornbill -Blyth‟s Hornbills -Pied Hornbills -Rhinoceros Hornbill -Great Hornbill

-Berenicornis comatus -Anorrhinus galeritus -Aceros plicatus -Antharacoceros coronatus -Buceros rinoceros -Buceros bicornis

-Enggang Bulu -Enggang Buluh -Burung Jawa -Burung Tangling -Enggang -Enggang Papan

33. Barbets Capitonidae -fire-tufted Barbet -Many-coloured Barbet -Little Barbet -Brown Barbet

-Psilopogonn pyrolophus -Megalaima rafflesi -Megalaima australis -Colorhampus fuliginosus

-Burung Tekukur Akar -Burung Takor Tukang Besi

34. Honey-guide Indicaoridae -Malay Honey-guide

-indicator archipelagus

-Musoh Lebah


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35. Woodpeckers Picidae -Speckled Piculet -Scally-bellied Woodpecker -Bamboo Green Woodpecker -Banded Red Woodpecker -Olive-backed Three-toed Woodpecker -Great Slaty Woodpecker -Marron Woodpecker -Pale-headed Woodpecker

-Picumnus innominatus -Picus virdanus -Picus vittatus -Picus miniaceus -Dinipium rafflesi -Mulleripicus pulverulentus -Blythipicus ribiginosus -Gecinulus grantia

-Pelatok Belang -Pelatok -Pelatok Hijau -Pelatok Merah -Pelatok Rimba -Pelatok Gajah -Pelatok Punggor -Pelatok Buluh

36.

Broadbills

Eyrylaimidae

-Green Broadbill -Long-tailed Broadbill -Balck-and-red Broadbill -Dusky Broadbill

-Calyptomena viridis -Psarisomus dalhousiae -Cybirhynchus macrorhynchos -Corydon sumtranus

-Burung Takau -Burung Hujan-hujan -Burung Rakit

37. Pittas

Pittidae -Giant Pitta -Garnet Pitta -Blue-tailed Pitta -Hooded Pitta

-Pitta caerulea -Pitta granatina -Pitta guajana -Pitta sordid

-Burung Pachat -Burung Pachat Kepala Merah -Burung Pachat ekor Biru -Burung Gembala Pelandok

38. Swallows and martins

Hirundinidae -House Martin -Barn Swallow -Pacific Swallow -Red-rumped Swallow

-Delichon urbica -Hirundo rustica -Hirundo tahitica -Hirundo striolata

-Layang-layang Gua


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39. Minivets and greybirds

Campephagidae -Hook-billed Greybird -Barref Greybird -Pied Triller -Ashy Minivet -Mountain Minivet -Scarlet Minivet

Tephrodornis gularis -Coracina striata -Lalage nigra -Percrocotus roseus -Pericrocotus solaris -Pericrocotus flammeus

-Merbah Rimba -Punai Rimba -Kuang Kuit -Burung Chok Padang -Burung Mata Hari

40. Bulbuls Pycnonotidae -Black-and-white Bulbul -Black-headed Bulbul -Black-crested Yellow Bulbul -Scaly-breasted Bulbul -Large Olive Bulbul

-Pycnonotus melanoleucos -Pycnonotus atriceps -Pycnonotus dispar -Pycnonotus squamatus -Pycnonotus plumosus

-Merbah Tandok Burung Siam -Merbah Kunyit -Merbah Bersisik -Murai Rimba

-Scrub Bulbul -Crested Bulbul -Mountain Streaked Bulbul -Ashy Bulbul

-Criniger bres -Criniger ochraceus -Hypsipetes moclellandi -Hypsipetes flavalus

-Burung Rabah -Merbah Berjanggut -Burung Barau Bukit -Burung Tuar

41.

Leafbirds and Fairy

Irenidae -Common Lora -Lesser Green Leafbird -Greater Green Leafbird -Fairy Bluebird

-Aeghitina tiphia -Chloropsis cyanopogon -Chloropsis sonnerati -Irena puella

-Kelichap Kunyit -Burung Daun Besar -Burung Daun Kecil -Murai Gajah

42.

Drongos Dicruridae -Crow-billed Drongo -Bronzed Drongo -Lesser Racket-tailed Drongo -Large Racket-tailed Drongo

-Dicrurus annectans -Dicrurus aeneus -Dicrurus remifer -Dicrurus paradiseus

-Chechawi -Burung Paha Kelati -Burung Chawi Chawi BurungCha Hamba Kera


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43. Orioles Oriolidae -Black-naped Oriole -Malaysian Black-headed Oriole

-Oriolus chinensis -Oriolus xanthonotus

-Burung Kunyet Besar -Burung Kunyet Kecil

44. Crows and jays

Corvidae -Crested Malay Jay -Green Magpie -Black-Crested Magpie

-Platylophus galericulatus -Kitta chinensis -Platysmurus leucopterus

-Burung Menjerit -Burung Gagak Gunung -Burung Kambing

45. Titmice Paridae -Sultan Tit

-Melanochlora sultanea

-Serai-serai

46. Nuthatches Sittidae -Velvet-fronted Nuthatch -Blue Nuthatch

-Sitta frontalis -Sitta azurea

47. Flycatchers Muscicapidae -Whtie-throated Fantail Flycatcher -Pied fantail Flycatcher -Niltava -Siberian Flycatcher -Pale Blue Flycatcher -Malaysian Blue Flycatcher -Tickell‟s Blue Flycatcher -Hill Blue Flycatcher -Narcissus Flycatcher -Maroon-breasted Flycatcher -Paradise Flycatcher -Japanese Paradise Flycatcher -Magrove Whistler

-Rhipidura albicollis -Rhipidura javanica -Muscicapa grandis -Muscicapa sibirica -Muscicapa unicolor -Muscicapa turcosa -Muscicapa Ticellae -Muscicapa banyumas -Muscicapa narcissina - Philentoma vilata -Terpsiphone paradise -Terpsiphone atrpcaudata -Pachycephala cinerea

-Merbah Gila Gunung -Merbah Gila -Burung Kubung Padi - - - -Kelicap Ranting - - -Merbah Batu -Murai Ekor Gading -Murai -Murai Bakau

48. Bablers Timaliidae -Rail babler

-Eupetes macrocerus

-Burung Gemabala Kera


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-Striped Babler -Blyth‟s Jungle Babbler -Abott‟s Jungle Babbler -Graeter Red-headed tree Babbler -Lesser-Red-headed Tree Babbler -Plain Bubbler -Striped Wren Babbler -Small Wren Babbler

-Pellorneum ruficeps -Trichastoma rostratum -Trichastoma abbotti -Malacopteron magnum -Malacopteron cinereum -Malacoperon affine -Kenopia striata -Napothera brevicaudata

- -Burung Terlanjor -Murai Belukar -Murai Rimba -Burung Tua Pulih

-Pygmy Wren Babbler -Striped Tit Babbler -Fluffy-backed Tit Babbler -White-eared Tree Babbler -Golden Tree Babbler -Silver-eared Mesia -Cutia -Common Nun Babbler -White-beilled Crested Babbler -White-headed Babbler -Long-tailed Sibia

-Pneopyga Pusilla -Macronus Gularis -Macronus ptilosus -Stachyris leucotis -Stachyris chrysea -Leiothrix argentauris -Cutia nepalensis -Alcippe poiocephala -Yuhina zantholeuca -Gamsorhynchus rufulus -Heterophasia picaoides

-Burung Resam -Merbah Sampah Kuning -Burung Pong-pong -Kelicap Bunga Kantan -Kelicap Mas -Murai Sampah -kelicap Berjambul


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49. Warblers Sylviidae -Fly-eater -Streaked Fantail Warbler -Green Leaf Warbler -Arctic Leaf Wabler -Streaked Grasshopper Warbler -White-throated Flycatcher Warbler -Black-necked Tailor Bird

-Gerygone fusca -Cristicola juncidis -Phylloscopus trivirgatus -Phylloscopus occipitalis -Locustella lanceolata -Seicercus superciliaris -Prthotomus atrogularis

-Kelicap Perepat -Burung Laki Padi -Burung Tikus -Kelicap Buluh -Kelicap Pucat Pisang

50. Thrushes Turdidae -Siberian Blue Robin -Common Shama -Chestnut-naped Forktail -Slaty-backed Forktail -Blue-Rock Thrush -Grey-headed Thrush -Blue Whistling Thrush -Stone Chat -Siberian Ground Thrush

-Luscinia cyane -Copsychus malabaricus -Enicurus ruficapillus -Enicurus schistaceus -Monticola Solitaria -Turdus obscures -Myiophoneus coeruleus -Saxicola torquata -Zoothera sibirica

-Murai Batu -Burung Chegar -Burung Chegar Besar -Burung Tarom -Murai Belanda -Tiong Belacan - -

51. Wagtails and pipits

Motacilidae -Grey Wagtail -Richard‟s Pipit -Forest Wagtail -Yellow Wagtail

-Motacilla cinerea -Anthus novaeseelandie -Motacilla indica -Motacilla flava

-Mentua Pelandok -Burung Apit-apit

52. Shrikes Laniidae -Schach Shrike -Brown Shrike -Thick-billed Shrike

-Lanius schach -Lanius shrike -Lanius tigrinus

-Burung Tirjup


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53. Flowerpeckers Dicaeidae -Scarlet-backed Flowerpecker -Javan Fire-breasted Flowerpecker -Plain Flowerpecker -Yellow-throated Flowerpecker -Hume‟s Flowerpecker

-Dicaeum cruentatum -Dicaeum sanguinolentum -Dicaeum concolor -Prionochilus maculates -Dicaeum modestum

-Burung Sepah Putri -Burung Sepah Putri Gunung

54. Sunbirds and spiderhunters

Nectariniidae -Brown-throated Sunbird -Ruby-cheeked Sunbird -Purple-naped Sunbird -Van Hasselt‟s Sunbird

-Anthreptes malacensis -Anthreptes singalensis -Nectarinia hypogrammica -Nectarinia sperata

-Kelicap Mayang Kelapa -Kelicap Belukar -Kelicap Rimba

-Yellow-backed Sunbird -Scarlet Sunbird -Little Spiderhunter -Lesser Yellow-eared Spiderhunter -Streaked Spiderhunter

-Aethopyga siparaja -Aethopyma mystacalis -Arachnothera longirostris -Arachnothera chrysogenys -Arachnothera magna

-Kelicap Jantong -Kelicap Pisang

55.

White-eye Zosteropidae -Oriental White-eyed

-Zosteropidae palpebrosa

-Kelicap Kunyit

56. Starling Sturnidae -Daurian Starling -Chinese Starling -Gold-crested Myna -Chinese Crested Myna

-Sturnus sturninus -Sturnus sinensis -Ampeliceps coronatus -Aridotheres cristatellus

57. Sparrows and finches

Ploceidae -Pin-tailed Parrot Finch -Bamboo Parrot Finch -Brown Bulfinch -Yellow-breasted Bunting

-Erythrura prasina -Erythrura hyperthra -Pyrrhula nipalensis -Emberiza aureola

-Chiak Perut Merah -Pipit Gunung


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Annex 3 Maximum Daily Levels of Vitamins and Minerals for adult allowed in Health Supplement

(*For pre and antenatal use, as part of a multivitamin and mineral preparation, levels higher than the 20mg limit established for adults may be permitted at the discretion of the DCA)

No Ingredients

Upper Daily Limit

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

Vitamin A Vitamin D Vitamin E Vitamin B1 (Thiamine) Vitamin B2 (Riboflavine) Vitamin B5 (Phatothenic acid) Vitamin B6 (Pyridoxine) Vitamin B12 (Cyanocobalamin) Vitamin C (Ascorbic Acid) Folic Acid Niacin (Nicotinic acid) Niacinamide (Nicotinamide) Biotin Calcium Copper Iodine Iron Magnesium Manganese Phosphorus Selenium Zinc Chromium

5000 IU 400 IU 400 IU 100 mg 40 mg 200 mg 100 mg 0.6 mg 1000 mg 15 mg 500 mg 250 mg 0.9 mg 1400 mg 2 mg 300 mcg 20 mg* 400 mg 5 mg 1400 mg 300 mg 25 mg 0.5 mg


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Annex 4

Claims Acceptable for Traditional Product

No Categories Indication Claims

1

General Health Maintenance

Traditionally used or homeopathically used..

for general health maintenance

for general health

for health and strengthening the body

for relief of body heatiness

for general debility, weakness after illness of childbirth

for loss of appetite

for difficulty in sleep

for relief of fatigue

as an aid to overcome fatigue during physical exertion

to expel wind and invigorate vital energy

to improve appetite

for relieving waist ache and body weakness

for relieving dizziness, sweating and difficulty in sleep

for reducing body odour

for reducing toothache

to relieve tired eyes

for healthy eyes

2

Blood & Body Fluid

Traditionally used for improving blood circulation

Traditionally used to improve urination

Traditionally used for improving bowel movement

Traditionally used for relieving mild vomiting

Traditionally used for reducing minor swelling

3

Bone, Muscle & Joint

Traditionally used for strengthening muscle & bone

Traditionally used for relieving muscular ache

Traditionally used for relieving waist ache and backache

Traditionally used for relief of joints and muscular pain

Traditionally used for relieving muscles sprain

4

Pain & Fever

Traditionally used to relieve / alleviate pain

Traditionally used for relieving fever

Traditionally used for relieving headache

Traditionally used for relieving pain and itchiness related to piles

Traditionally used for symptomatic of body heatiness or body heat


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5

Cough & Cold

Traditionally used for relief of fever, cough and cold

Traditionally used for relief of sore throat

Traditionally used for reducing phlegm and relief cough, sore throat and body heatiness

Traditionally used for relief of throat irritations and cough

Traditionally used for relief nasal congestion

Traditionally used for relief of sore throat and cough

Traditionally used for relief of mouth ulcers due to heartiness

Traditionally used to relieve sinusitis

6

Digestive System

Traditionally used for relief stomach ache, mild diarrhoea

Traditionally used for relief of flatulence, stomach ache, mild diarrhoea and loss of appetite

Traditionally used for relief mild diarrhoea, vomiting and improve appetite

Traditionally used for relief mild constipation

Traditionally used to improve appetite and digestion

Traditionally used for relieving abdominal pain and flatulence

Traditionally used for relief of stomach ache, constipation, mild vomiting and indigestion

Traditionally used for aid in digestion

7

Women‟s Health

Traditionally used to relief menstrual pain, headache and regulate menstruation

Traditionally used to reduce body weight

Traditionally used for relief of vaginal discharge

Traditionally used for women after childbirth

Traditionally used for general wellbeing and strengthen the body after childbirth

Traditionally used for women after childbirth to reduce body weight

Traditionally used for symptomatic relief of vaginal discharge and mild itch

Traditionally used to improve menstrual flow, for relief of menstrual pain, vaginal discharge and flatulence

Traditionally used for strengthening body muscle and reducing body weight

Traditionally used for general health of women after childbirth

Traditionally used to relief symptoms of menopause (for specific ingredients only examples: Red clover ( Trifolium Pratense) and Black cohosh ( Cirmicifuga racemosa )

8

Men‟s Health

Traditionally used for energy and men‟s health / for vitality


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9

Skin and external use

Traditionally used for symptomatic relief of pain and itch associated with insect bites

Traditionally used for relief of minor burns

Traditionally used for relief cuts

Traditionally used or relief of minor bruises

Traditionally used for reducing pimples

Traditionally used to help maintaining healthy skin, nail and hair

Traditionally used for reducing pimples and mild itch


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Annex 5

Functional Claims acceptable for Health Supplement

No Item Claims

1

Vitamin A

Maintenance of good health

Helps to maintain growth, vision and tissue development

Aids in maintaining the health of the skin and mucosa membrane

2

Vitamin C

For health bones, teeth, gums as well as general make-up of the body

3

Vitamin D


Helps in normal development & maintenance of bones and teeth

Claim for specific population subgroups; -elderly people who are confine indoors

Helps the body utilize calcium and phosphorus

4

Vitamin E


5

Thiamine (Vitamin B1)

Helps to maintain good health

Helps normal growth

Helps the body to metabolize carbohydrates

6

Beta Carotene


Helps in maintenance of growth, vision and tissue differentiation

7

Riboflavin (Vitamin B2)

A factor in maintenance of good health

Helps the body to utilize energy from food/metabolize proteins, fats and carbohydrate

Claim for specific population subgroups: - Additional amounts of Riboflavin are required

during pregnancy and breast feeding when diet does not provide a sufficient daily intake

8

Niacin (Vitamin B3)


Helps normal growth and development

Helps the body in utilization of energy from food

9

Pyridoxine (Vitamin B6)


Helps the body to metabolize proteins, fats and carbohydrates

10

Cyanocobalamine (Vitamin B12)

Helps in maintenance of good health

Helps in formation of red blood cell


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11

Folic Acid

Helps in the formation of red blood cell

Helps prevent neural tube defects for women who are planning a pregnancy before conception and during 12 weeks of pregnancy at a dose of 400mcg daily

12

Biotin


Helps to metabolize fats and carbohydrates

13 Pantothenic Acid Helps in maintaining of good health

Helps to metabolized fats and carbohydrates

14 Calcium Helps in maintaining in good health

Helps in the formation and maintenance of bones and teeth

Claim for specific population subgroups; -Additional calcium is required for pregnant and lactating women, when diet does not provide a daily sufficient intake to help in proper bone formation in developing baby

15 Phosphorus Helps in maintenance of good health

Helps in the formation and maintenance of bones and teeth

16

Magnesium


Helps the body to metabolize carbohydrate

17

Iron



Helps to prevent iron anaemia

Helps to prevent anaemia due to iron deficiency

18

Iodine


Helps in the function of the thyroid glands

19

Zinc


Helps to metabolize carbohydrates, fats and protein

20

Copper



21

Manganese


Helps the body to metabolize carbohydrates and protein

22 Probiotics Helps improve a beneficial intestinal microflora


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Annex 6 List of Non Permissible Indications for Natural Product 1. Diseases or defects of the kidney 2. Diseases or defects of the heart 3. Diabetes 4. Epilepsy or fits 5. Paralysis 6. Tuberculosis 7. Asthma 8. Leprosy 9. Cancer 10. Deafness 11. Drug addiction 12. Hernia or rupture 13. Diseases of the eye 14. Hypertension 15. Mental disorder 16. Infertility 17. Frigidity 18. Impairment of sexual function or impotency 19. Venereal disease

-Nervous debility or pother complaint of infirmity arising from or relating to sexual intercourse.


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Annex 7

Quest3 Online Submission System How to access the Quest3 System

(i) First Time User

You must first register your membership particulars online at www.bpfk.gov.my. Please go to

Quest 3 main page.Click at First-Time User Registration.

Source : National Pharmaceutical Control Bureau Webpage (www.bpfk.gov.my)

Figure 1:National Pharmaceutical Control Bureau Main Webpage for first time user



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Click at “Guide for first-time registration”

Here you will be explained on how to register and fill up the registration memberslip form


Figure 2: Guide for first-time registration


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Fill up the Quest3 Membership and Registration Form to register your membership.


Figure 3: Membership & Digital Certificate Registration Form

You are required to attach a scanned copy of the following documents on your membership registration form.

1. Copy of the identity card of the applicant (front only) 2. Letter of authorization from the company authorising the applicant 3. Company registration form


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After you have completed the registration form, please select the appropriate package for the package of Digital Certification.


Figure 4: Package of Digital Certification

The package are either package A, B or C and including USB token, guide manual and digital certificate for 1 or 2 years validity.


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Please read the terms of service before you make a declaration by accepted the notification of acceptance.


Figure 5: BPFK Quest3 Member Terms of Services Click at the column “I have read and agree to the terms of service” if you agree with the terms of services.


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After you have complete the registration form and declared the terms of service, click the submit registration button to go to BPFK Quest3 Membership Registration.


Figure 6: Submit the registration form

Once you have submitted online, you are required to print the membership registration slip and click at “Download slip” button and make payment as instructed in the slip.


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Example of membership registration


Figure 7: BPFK Quest3 Membership Registration Slip Send the Membership Slip together with the following documents:

1. Copy of the identity card of the applicant (front only); 2. Authorised person signature (on membership registration slip)


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3. Copy of your company‟s letter authorisation; 4. Copy of Company Registration Form 5. Payment in money order or postal order.

To: Digicert Sdn Bhd (457608-K), No. 3-20 & 3-22, Jalan Jalil Perkasa14, Aked Esplaned, Bukit Jalil, 57000 Kuala Lumpur. Tel: 03-89928888

Payment for the Smart Card System must be made to Digicert Sdn Bhd. You can make the payment by using either money order or postal order after you submit the application of Quest 3 via online. The USB token will be sent to you by POS LAJU within 7 working days upon receipt of payment to the company address specified in the form. Your password to logon to the system will be emailed to you at the email address specified in the form upon registration approval by BPFK.

To begin your product registration application, go to the www.bpfk.gov.my/ webpage, and click on the Quest3 System main page. Enter your correct login name and password. You may start submitting your application online from there on.



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(ii) Existing Quest 2 User Please go to main website NPCB and click at Quest 3 link.

Source: National Pharmaceutical Control Bureau Webpage (www.bpfk.gov.my)

Figure 8: National Pharmaceutical Control Bureau Main Webpage


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To access to the Quest3 system please click at “registered user? Please click here”


Figure 9: National Pharmaceutical Control Bureau Quest3 Webpage



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Key in the smart card pin number, and verify your identity by clicking at “verify my identity”


Figure 10: Verified your identity



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After you have verified your identity, the system required you to login the system.



You may log in with your previous username and new password. The new password is Quest3. As the first time user with Quest 3 system, you are required to change your password and reconfirm the password.

After you change the password, the system will automatically log in into Quest 3 Account.



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Once you have successfully logged in, choose new registration form for traditional or pharmaceutical product and you can start submitting your applications online from there on.



In the registration section, you may submit the new application for new product such as NCE, Biotechnology, Poison, OTC, Health Supplement and Traditional. In Cosmetic section, you may submit the new application for new cosmetic notification. In Lab section, you may submit of the registration sample for traditional product only.

Validity The validity of the smart card is 2 years. Within 30 days before the expiry date, the system will notify you through your email address for renewal of your smart card. For more information regarding the Smart Card system, please contact Digicert Sdn Bhd at 03-89943066 or email at [email protected]




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Annex 8 Example of Import Permit


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Example of application letter for import permit


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References: 1. National Pharmaceutical Control Bureau www.bpfk.gov.my

2. Department of Wildlife and National Park www.wildlife.gov.my

For further information, please contact:

Vice President Operational Services Department Business Operation Division Malaysian Biotechnology Corporation Sdn Bhd Level 23 Menara Atlan 161 Jalan Ampang 50450 Kuala Lumpur Tel: 03 2116 5588 Fax: 03 2116 5528 Email: [email protected]



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