GUIDELINES ON REGISTRATION OF TRADITIONAL AND HEALTH SUPPLEMENT PRODUCTS

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 MALAYSIAN BIOTECHNOLOGY CORPORATI...
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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

MALAYSIAN BIOTECHNOLOGY CORPORATION SDN BHD (Company No. 691431-D)

GUIDELINES ON REGISTRATION OF TRADITIONAL AND HEALTH SUPPLEMENT PRODUCTS

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.

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Table of Contents

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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 3.2 3.3 3.4 3.5 3.6

Who can apply for product registration ........................................................................... 2 Quest3 Online Submission System ................................................................................. 2 How to register the traditional & health supplement product ......................................... 3 Product Validation........................................................................................................... 3 Admin Information .......................................................................................................... 3 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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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

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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.

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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.

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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. ii.

3.4

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

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. 

3.5

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

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. II. III. IV. V.

C1 : C2 : C3 : C4 : C5:

pack size and fill details by weight, volume or quantity container type barcode no recommended distributor‟s price (not compulsory) 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 Batch Manufacturing Formula In Process Quality Control Finished Product Specification Stability Data

  

For Imported Products Batch Manufacturing Formula In Process Quality Control Finished Product Specification Stability Data

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    

Label (Mock Up) for immediate Container Label (Mock Up) for outer Carton Good Manufacturing Practice Certificate (GMP) Protocol of Analysis  Certificate of Analysis

   

   

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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 Certificate of Analysis

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.

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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).

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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 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 Certificate of Analysis 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

 

  

 

For Imported Products 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 Certificate of Analysis 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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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

Apply for Digicert Smart Card System (Quest3)

Submit documentation via Quest3 System (online)

Step 1

Step 2

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. -Liver toxicity

Botanical‟s name (& botanical ingredients) 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 Aristolochia spp

Common or other names 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. 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 Aristolochia kwangsiensis Chun 7 F.C. How Syn. Aristolochia austroszechuanica C. B Chien & C. Y. Cheng

Indian birthwort Yellowmouth Dutchman;s pipe

Aristolochia macrophylla Lam. Syn. Aristolochia siphon L‟Hér. Aristolochia manschuriensis Kom. Syn. Hocquartia manshuriensis (Kom.) Nakai Syn. Isotrema manchuriensis (Kom.) H. Huber

Dutchman‟s-pipe 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. Aristolochia watsoni Wooton & Standley or Aristolochia watsonii Wooton & Standley Syn. Aristolochia porphyropyylla Pfeifer Aristolochia westlandii Hemsl. Or Aristolochia westlandi Hemsl.

Virginia snakeroot Serpentaria Virginia serpentary

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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* Akebia spp.

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

Akebia trifoliate (thumb.) Koidz.

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

Common or Other Names Akebia Mu tong Ku mu tong Zi mutong Bai mu tong Mokutsu (Japanese) Mokt‟ong (Korean) Chocolate vine Fiveleaf akebia Mu tong Yu zhi zi Mukotsu (Japanese) Mu tong Three leaf akebia Yu zhi zi 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. Clematis chinensis Osbeck.

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

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

Cocculus

Syn. Epibaterium carolinum (L.) Britton Syn. Menispermum carolinum L. 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. Cocculus laurifolius DC. Syn. Cinnamomum esquirolii H. Lév.

Indian cockle

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

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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

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

Vladimiria souliei (franch) Ling

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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 1

English Name Javan Rhinoceros

Scientific Name Rhinoceros sondaicus

Malay Name Badak Raya

2.

Sumatran Rhinoceros

Didermocerus sumatrensis

3.

Tapir

4.

Banteng

Bos banteng

Banteng, Sapi, hutan

5.

Siamang

Hylobates syndactylus

Siamang

6.

Agile Gibbon

Hylobates agilis

Wak-wak

7.

White-handed Gibbon

Hylobates lar

Ungka

8.

Scaly anteater or Pangolin

Manis javanica

Tenggiling

9.

Malayan wild Dog

Cuon alpines

Serigala, Anjing hutan

10.

Clouded Leopard

Neofelis nebulosa

Harimau dahan

11.

Marbled Cat

Felis marmorata

Kucing dahan

12.

Flat-headed Cat

Felis planiceps

Kucing hutan

13.

Golden Cat

Felis temminckii

Kucing tulip

14.

Linsang

Prionodon linsang

Linsang

15.

Binturong or Bear-cat

Artictis binturong

Binturong

16.

Slow Loris

Nyticebus caucang

Kongkang, kera duku

17.

Otter civet

Cynogale bennettii

Musang memerang

18.

Derby‟s Banded Civet

Badak Kerbau Badak Chipan, Badak Tampong

Tapirus Indicus

Hemigalus derbyanus

Musang belang

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

19.

Version 1.0 st Dated 1 Dec 2011

Martes flavigula

Mengkira

20.

Yellow-throated Marten Weasel

Mustela nudipes

Pulasna

21.

Long-tailed porcupine

Trichys lipura

Landak padi

22.

Serow

Capricornis sumatrensis

Kambing gurun,

23.

Selangor Pigmy Flying Squirrel

Petaurillus kinlochii

Tupai terbang terkecil

24.

Red-cheeked Flying Squirrel

Hylopetes spadiceus

Tupai terbang pipi merah

25.

Grev-cheeked Dlying

Hylopetes Lepidus

Tupai terbang squirrel pipi kelabu

26.

Whiskered Flying squirrel

Petinomys genebarbis

Tupai terbang berjambang

27.

White-Bellied Flying

Petinomys setosus

28.

Vordemann‟s Flying

Petinomys vordermanni

29.

Horsfield‟s Flying Squirrel

Lomys horsfieldii

30.

Smoky Flying squirrel

31.

Large Black Flying Squirrel

Pteromyscus pulverulentus Aeromys tephromelas

Tupai terbang hitam

32.

Red Giant Flying Squirrel

Petaurista Petautista

Tupai terbang merah

33.

Spotted Giant Flying

Petaurista elegant

Tupai terbang squirrel bintang

34.

Malayan Flying Lemur

Cynocephalus

Kubong

Tupai terbang squirrel dada putih Tupai terbang squirrel kecil Tupai terbang ekor merah

Tupai terbang kotor

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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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. Elephant Elephas maximus Gajah 2. Gaur Bos gaurus hubbacki Seladang Part II : Binatang-binatang perburuan ( Prey animals) 1. 2. 3. 4. 5. 6.

Sambur Deer Barking Deer Large Muose-Deer Lesser Muose-Deer Tiger Leopard

7. 8. 9.

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.

Hairy-nosed Otter Smooth Otter Common Otter Small-clawed Otter Common Palm Civet

6. 7. 8.

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

9. 10. 11. 12. 13. 14. 15. 16. 17. 18.

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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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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THIRD SCHEDULE COMPLETELY PROTECTED WILD BIRDS

No

Name

Family

English Name

Scientific Name

Malay Name

1. 2.

Grebes Petrels

Podicipididae Hydrobatidae

3.

Tropic Birds

Phaethontidae

-Little Grebe -Wilson‟s Storm Petrel -Short-tailed Tropic Bird

-Podiceps ruficollis -Oceanitis Occeanicus -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

8.

Frigate Birds

Fregatidae

-Christmas Island Frigatebird

-Fregata andrewsi

-Burung kosa -Burung Simbang Pulau

9.

Herons

Ardeidae

-Dusky-grey Heron -Cattle Egret

-Ardae sumantrana

10.

Stork

Ciconiidae

11.

Ibises

Threskiornithidae

-Burung Lembu -Bubulcus ibis -Burung Bangau -Chinese Egret -Egreetta eulophotes Burung Bangau China -Night Heron -Nycticorax -Burung nycticorax kuak -Cinnamon -Ixobrychus Bittern eurhythmus -Puchong Bendang -Milky Stork -Ibis lcinereus -Burung -Storm‟s Stork -Ciconia stormi Upeh -Lesser -Leptoptilos Adjuntant Stork javanicus -Burung Botak -White Ibis -Threskiornis -Burung aethiopica Sekendi

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

12.

Hawks and Eagles

Accipitridae

Version 1.0 st Dated 1 Dec 2011

-Bat Hawk

-Machaerhamphus alcinus -Crested -Pernis Honey Buzzard ptilorhynchus -Black Eagle -Ictinaetus malayensis -King Vulture -Torgos calvus -Long-billed Vulture

-Gyps indicus

-White-backed Vulture

-Pseudogyps bengalensis

-Marsh Harrier

-Circus aeruginosus

-Short-toed Eagle

-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 -Long-billed Partridge -Black Wood Partridge -Roulroul -Chestnutbreasted Partridge -Malay Peacock Pheasant -Rothschild‟s

-Microhierex caerulescens -Falco peregrines

-Lang Rajawali

15.

Pheasants, partidges

Phansianidae

-Great Argus -Green Peafowl

16.

Cranes

Gruidae

-Eastern Sarus Crane

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

-Grus antigone

-Burung Selanting -Burung Bertam -Burung Siul -Sang Serok

-Merak Pongsu -Kuang Raya Gunung -Kuang Raya -Merak -Burung Keria

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

17.

Rails, Crakes & gallinules

Rallidae

-Purple Coot -Masket Finfoot

18.

Jacanas

Jacanidae

19.

Gulls & terns

Laridae

20.

21.

Pigeons & Doves

Cukcoos

Columbidae

Cuculidae

Version 1.0 st Dated 1 Dec 2011

-Porphyrio Porphyria -Heliopais personata

-Panglin -Burung Pedendeng

-Pheasanttailed Jacana -Bronzeweiged Jacana -White-winged Black Tern -Common Tern -Roseate Tern

-Hydrophasianus Chirurgus -Metopidius indicus

-Burung Teratai

-Chlidonias leucoptera -Sterna hirundo -Sterna doughalli

-Little Tern -Crested Tern

-Sterna albifrons -Sterna bergii

-Common Noddy

-Anous stolidus

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

-Nicobar pigeon -Pied Imperial Pigeon -Mountain Imperial Pigeon

-Coloenas nicobarica -Ducula bicolour

-Merpati Mas -Rawa

-Ducula badia

-Pergam Bukit

-Red Turtle Dove -Lesser Hawk Cuckoo -Hawk Cuckoo

-Banded Bay Cukcoo -Koel -Lesser Green-billed Malcoha -Large Greenbilled Malcoha -Raffles‟s Malcoha

-Streptopelia tranquebarica

-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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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

22.

23.

Typical owls

Barn Owls

Strigidae

Tytonidae

Version 1.0 st Dated 1 Dec 2011

-Collared Scops Owl -Scops Owl

-Otus bakkamoena

-Reddish Scops Owl -Malay Eagle Owl -Fish Owl -Pygmy Owlet

-Otus rufescens

-Spotted Wood Owl

-Strix seluputo

-Otus scops

-Bubo sumatranus -Bubo ketupu -Glaucidium brodiei

-Barn Owl -Bay Owl

24.

Frogmounths

Podargidae

-Large Frogmouth -Blyth‟s Frogmouth

-Batracostomus auritus -Batrachostomus affinis

25.

Nightjars

Carprimulgidae

26.

Swifts

Apodidae

-Eurostopodus temmincki -Caprimulgus macrurus -Caprimulgus indicus -Collocalia gigas -Collocalia fuciphaga

27.

Tree Swift

Hemiprocnidae

-Malaysian Eared Nightjar -Long-tailed Nightjar -Migratory Nightjar -Giant Swiftlet -Grey-rumped Swiftlet -White-bellied Swiftlet -Malaysian Spinetail Swift -Migrant Swift -Crested Tree Swift

28.

Trogons

Trogonidae

-Burung Jampok -Burung Hantu

-Burung Punggok Kechil -Burung Charekkafan -Burung Punggok Api -Burung Segan

-Burung Taptibau -Burung Kuber -

-Layanglayang Gua -Collocalia esculenta -Layang padi -Chaetura gigantean -Layanglayang -Apus pacificus besar -Hemiprocne -Layanglongipennis layang Berjambol -Hemiprocne comate

-Whitewhiskered Tree Swift -Red-naped -Harpactes kasumba Trogan -Diard‟s -Harpactes Trogon Tragon -Orange-Harpacted oreskios breasted Trogon

-Burung Kesumba

-Burung Gembala Rimau

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

29.

Kingfishers

Alcedinidae

-Common Kingfisher -Blue-banded Kingfisher -Brown-winged Stork-billed Kingfisher -White-collared Kingfisher

30.

Bee-eaters

Meropidae

-Bay-haeaded Bee-eater -Blue-throated Bee-eater

31.

Rollers

Crocidae

-Burmese Roller

31. 32.

Hoopoe Hornbills

Upupide Bucerotidae

-Broad-billed Roller -Hoopoe -White-crested Hornbill -Bushy-crested Hornbill -Blyth‟s Hornbills -Pied Hornbills

Version 1.0 st Dated 1 Dec 2011

-Alcedo atthis -Alcedo auryzona -pelargopsis amauroptera

-Pekaka Chitchit -Pakaka Bukit -Burung Buaya

-Halcyon concreata -Raja Udang -Merops leschenaulti -Berekberek -Merops viridis -Rengkok Biru -Coracias benghalensis -Eyrystomus -Tiong Batu orientalis

33.

Barbets

Capitonidae

-fire-tufted Barbet -Manycoloured Barbet -Little Barbet -Brown Barbet

-Upupa epops -Berenicornis -Enggang comatus Bulu -Anorrhinus galeritus -Enggang Buluh -Aceros plicatus -Burung -Antharacoceros Jawa coronatus -Burung -Buceros rinoceros Tangling -Enggang -Buceros bicornis -Enggang Papan -Psilopogonn -Burung pyrolophus Tekukur -Megalaima rafflesi Akar -Burung -Megalaima australis Takor -Colorhampus Tukang fuliginosus Besi

34.

Honey-guide

Indicaoridae

-Malay Honeyguide

-indicator archipelagus

-Rhinoceros Hornbill -Great Hornbill

-Musoh Lebah

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

35.

36.

Woodpeckers

Broadbills

Picidae

Eyrylaimidae

-Speckled Piculet -Scally-bellied Woodpecker -Bamboo Green Woodpecker -Banded Red Woodpecker -Olive-backed Three-toed Woodpecker -Great Slaty Woodpecker -Marron Woodpecker -Pale-headed Woodpecker -Green Broadbill -Long-tailed Broadbill -Balck-and-red Broadbill -Dusky Broadbill

37.

Pittas

Pittidae

Version 1.0 st Dated 1 Dec 2011

-Picumnus innominatus -Picus virdanus

-Pelatok Belang -Pelatok

-Picus vittatus

-Pelatok Hijau

-Picus miniaceus -Dinipium rafflesi

-Mulleripicus pulverulentus -Blythipicus ribiginosus -Gecinulus grantia

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

-Giant Pitta

-Pitta caerulea

-Garnet Pitta

-Pitta granatina

-Blue-tailed Pitta

-Pitta guajana

-Pitta sordid -Hooded Pitta

38.

Swallows and martins

Hirundinidae

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

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

-Pelatok Merah -Pelatok Rimba -Pelatok Gajah -Pelatok Punggor -Pelatok Buluh -Burung Takau -Burung Hujanhujan -Burung Rakit

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

-Layanglayang Gua

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

39.

40.

Minivets and greybirds

Bulbuls

Campephagidae

Pycnonotidae

Version 1.0 st Dated 1 Dec 2011

-Hook-billed Greybird -Barref Greybird -Pied Triller -Ashy Minivet

Tephrodornis gularis

-Mountain Minivet -Scarlet Minivet

-Pericrocotus solaris

-Black-andwhite Bulbul -Black-headed Bulbul -Black-crested Yellow Bulbul -Scalybreasted Bulbul -Large Olive Bulbul -Scrub Bulbul

-Pycnonotus melanoleucos -Pycnonotus atriceps

-Merbah Tandok Burung Siam

-Pycnonotus dispar

-Crested Bulbul

-Criniger ochraceus

-Merbah Kunyit -Merbah Bersisik -Murai Rimba -Burung Rabah -Merbah Berjanggut

-Mountain Streaked Bulbul

-Hypsipetes moclellandi -Hypsipetes flavalus

-Coracina striata -Lalage nigra -Percrocotus roseus

-Pericrocotus flammeus

-Pycnonotus squamatus -Pycnonotus plumosus -Criniger bres

-Ashy Bulbul 41.

Leafbirds and Fairy

Irenidae

-Common Lora

-Aeghitina tiphia

-Lesser Green Leafbird

-Chloropsis cyanopogon

-Greater Green -Chloropsis Leafbird sonnerati -Fairy Bluebird -Irena puella 42.

Drongos

Dicruridae

-Crow-billed Drongo -Bronzed Drongo -Lesser Racket-tailed Drongo -Large Rackettailed Drongo

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

-Dicrurus annectans

-Burung Barau Bukit

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

-Dicrurus aeneus

-Burung Paha Kelati -Dicrurus remifer -Burung Chawi -Dicrurus paradiseus Chawi BurungCha Hamba Kera

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

43.

Orioles

Oriolidae

44.

Crows and jays

Corvidae

45.

Titmice

Paridae

46.

Nuthatches

Sittidae

47.

Flycatchers

Muscicapidae

48.

Bablers

Timaliidae

Version 1.0 st Dated 1 Dec 2011

-Black-naped Oriole -Malaysian Black-headed Oriole

-Oriolus chinensis

-Burung Kunyet -Oriolus xanthonotus Besar -Burung Kunyet Kecil -Crested Malay -Platylophus -Burung Jay galericulatus Menjerit -Green Magpie -Kitta chinensis -Burung Gagak Gunung -Black-Crested -Platysmurus -Burung Magpie leucopterus Kambing -Sultan Tit -Melanochlora -Serai-serai sultanea -Velvet-fronted -Sitta frontalis Nuthatch -Blue Nuthatch -Sitta azurea -Whtie-Rhipidura albicollis -Merbah throated Gila Fantail Gunung Flycatcher -Pied fantail -Rhipidura javanica Flycatcher -Niltava -Muscicapa grandis -Merbah Gila -Siberian -Muscicapa sibirica -Burung Flycatcher Kubung Padi -Pale Blue -Muscicapa unicolor Flycatcher -Malaysian -Muscicapa turcosa Blue Flycatcher -Tickell‟s Blue -Muscicapa Ticellae -Kelicap Flycatcher Ranting -Hill Blue -Muscicapa Flycatcher banyumas -Narcissus -Muscicapa Flycatcher narcissina -Maroon- Philentoma vilata -Merbah breasted Batu Flycatcher -Murai -Paradise -Terpsiphone Ekor Flycatcher paradise Gading -Japanese -Terpsiphone -Murai Paradise atrpcaudata Flycatcher -Murai -Magrove -Pachycephala Bakau Whistler cinerea -Rail babler

-Eupetes macrocerus

-Burung Gemabala Kera

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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

-Small Wren Babbler -Pygmy Wren Babbler -Striped Tit Babbler

Version 1.0 st Dated 1 Dec 2011

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

-Napothera brevicaudata

-Pneopyga Pusilla -Macronus Gularis

-Fluffy-backed Tit Babbler -White-eared Tree Babbler

-Macronus ptilosus

-Golden Tree Babbler -Silver-eared Mesia -Cutia -Common Nun Babbler -White-beilled Crested Babbler -White-headed Babbler -Long-tailed Sibia

-Stachyris chrysea

-Stachyris leucotis

-Leiothrix argentauris -Cutia nepalensis -Alcippe poiocephala -Yuhina zantholeuca

-

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

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

-Murai Sampah -kelicap Berjambul

-Gamsorhynchus rufulus -Heterophasia picaoides

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

49.

Warblers

Sylviidae

50.

Thrushes

Turdidae

51.

Wagtails and pipits

Motacilidae

-Fly-eater

-Gerygone fusca

-Streaked Fantail Warbler -Green Leaf Warbler -Arctic Leaf Wabler -Streaked Grasshopper Warbler -Whitethroated Flycatcher Warbler -Black-necked Tailor Bird -Siberian Blue Robin -Common Shama -Chestnutnaped Forktail -Slaty-backed Forktail -Blue-Rock Thrush -Grey-headed Thrush -Blue Whistling Thrush -Stone Chat -Siberian Ground Thrush -Grey Wagtail

-Cristicola juncidis

-Richard‟s Pipit

52.

Shrikes

Laniidae

Version 1.0 st Dated 1 Dec 2011

-Phylloscopus trivirgatus -Phylloscopus occipitalis -Locustella lanceolata -Seicercus superciliaris -Prthotomus atrogularis

-Kelicap Perepat -Burung Laki Padi

-Burung Tikus -Kelicap Buluh -Kelicap Pucat Pisang

-Luscinia cyane

-Murai Batu -Copsychus -Burung malabaricus Chegar -Enicurus ruficapillus -Burung Chegar -Enicurus Besar schistaceus -Burung -Monticola Solitaria Tarom -Murai -Turdus obscures Belanda -Tiong -Myiophoneus Belacan coeruleus -Saxicola torquata -Zoothera sibirica -Motacilla cinerea

-Anthus novaeseelandie -Forest Wagtail -Motacilla indica -Yellow -Motacilla flava Wagtail -Schach Shrike -Lanius schach -Brown Shrike -Lanius shrike -Thick-billed -Lanius tigrinus Shrike

-Mentua Pelandok -Burung Apit-apit

-Burung Tirjup

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

53.

54.

Flowerpeckers

Sunbirds and spiderhunters

Dicaeidae

Nectariniidae

55.

White-eye

Zosteropidae

56.

Starling

Sturnidae

57.

Sparrows and finches

Ploceidae

Version 1.0 st Dated 1 Dec 2011

-Scarletbacked Flowerpecker -Javan Firebreasted Flowerpecker -Plain Flowerpecker -Yellowthroated Flowerpecker -Hume‟s Flowerpecker -Brownthroated Sunbird

-Dicaeum cruentatum -Dicaeum sanguinolentum

-Burung Sepah Putri -Burung Sepah Putri Gunung

-Anthreptes malacensis

-Kelicap Mayang Kelapa

-Ruby-cheeked Sunbird -Purple-naped Sunbird -Van Hasselt‟s Sunbird -Yellow-backed Sunbird -Scarlet Sunbird

-Anthreptes singalensis -Nectarinia hypogrammica -Nectarinia sperata

-Kelicap Belukar -Kelicap Rimba

-Little Spiderhunter -Lesser Yellow-eared Spiderhunter -Streaked Spiderhunter -Oriental White-eyed -Daurian Starling -Chinese Starling -Gold-crested Myna -Chinese Crested Myna -Pin-tailed Parrot Finch -Bamboo Parrot Finch -Brown Bulfinch -Yellowbreasted Bunting

-Arachnothera longirostris -Arachnothera chrysogenys

-Kelicap Jantong -Kelicap Pisang

-Arachnothera magna -Zosteropidae palpebrosa -Sturnus sturninus

-Kelicap Kunyit

-Dicaeum concolor -Prionochilus maculates -Dicaeum modestum

-Aethopyga siparaja -Aethopyma mystacalis

-Sturnus sinensis -Ampeliceps coronatus -Aridotheres cristatellus -Erythrura prasina -Erythrura hyperthra -Pyrrhula nipalensis -Emberiza aureola

-Chiak Perut Merah

-Pipit Gunung

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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

(*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)

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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Annex 4 Claims Acceptable for Traditional Product No Categories 1 General Health Maintenance

Indication Claims 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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 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

5

Cough & Cold

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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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 1

Item Vitamin A

2

Vitamin C

3

Vitamin D

4

Vitamin E

5

Thiamine (Vitamin B1)

6

Beta Carotene

7

Riboflavin (Vitamin B2)

8

Niacin (Vitamin B3)

9

Pyridoxine (Vitamin B6)

10

Cyanocobalamine (Vitamin B12)

Claims  Maintenance of good health  Helps to maintain growth, vision and tissue development  Aids in maintaining the health of the skin and mucosa membrane  For health bones, teeth, gums as well as general make-up of the body  Maintenance of good health  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  Maintenance of good health  Helps to maintain good health  Helps normal growth  Helps the body to metabolize carbohydrates  Maintenance of good health  Helps in maintenance of growth, vision and tissue differentiation  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     

A factor in maintenance of good health Helps normal growth and development Helps the body in utilization of energy from food A factor in maintenance of good health Helps the body to metabolize proteins, fats and carbohydrates

 Helps in maintenance of good health  Helps in formation of red blood cell

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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 in maintenance of good health  Helps to metabolize fats and carbohydrates

13

Pantothenic Acid

 Helps in maintaining of good health  Helps to metabolized fats and carbohydrates

14

Calcium

15

Phosphorus

16

Magnesium

 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  Helps in maintenance of good health  Helps in the formation and maintenance of bones and teeth  Helps in maintenance of good health  Helps the body to metabolize carbohydrate

17

Iron

18

Iodine

19

Zinc

20

Copper

21

Manganese

 A factor in maintenance of good health  Helps the body to metabolize carbohydrates and protein

22

Probiotics

 Helps improve a beneficial intestinal microflora

     

Helps in maintenance of good health Helps in formation of red blood cell Helps to prevent iron anaemia Helps to prevent anaemia due to iron deficiency Helps in maintenance of good health Helps in the function of the thyroid glands

 A factor in maintenance of good health  Helps to metabolize carbohydrates, fats and protein  A factor in maintenance of good health  Helps in formation of red blood cell

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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

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

Figure 2: Guide for first-time registration

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

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

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.

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

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.

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

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.

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

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

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

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”

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

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”

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

Figure 10: Verified your identity

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

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

Figure 3: National Pharmaceutical Control Bureau Quest3 Webpage

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.

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

Figure 3: National Pharmaceutical Control Bureau Quest3 Webpage 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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