BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

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

GUIDELINES ON REGISTRATION OF TRADITIONAL AND HEALTH SUPPLEMENT PRODUCTS

8 July 2009

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

Version 1.0 Dated 08 July 2009

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 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 Quest2 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 Annex 2 Annex 3 Annex 4 Annex 5 Annex 6

List of prohibited Botanicals (Herbs and herbal derivatives) ................. 7 Wildlife whose use is prohibited in traditional medicine ...................... 16 Claims acceptable for Traditional Products......................................... 30 Functional Claims acceptable for Health Supplement ........................ 33 Quest2 Online System ........................................................................ 35 Example of Import Permit and Application Letter of Import Permit ..... 41



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OBJECTIVES AND INTRODUCTION 1.1

Objectives The objectives 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 relevent sections of the Drug Registration Guidance Document January 2008 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 included: • • • •

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? A traditional product is any product used in the practice of indigenous medicines. The product may consist of one or more naturally occuring substance of a plant. Animal or mineral origin or part thereof and it can be in an extracted or nonextracted form. It includes homeopathic medicines, ayurvedic medicines and medicated plasters. Examples include Misai Kucing, Aloe Vera, Noni Juice, Royal Jelly and other similar products. 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? A health supplement is a preparation intended to supply nutrients such as vitamins, minerals, fatty acids or amino acids, that are missing or are not consumed in sufficient quantity in a person's diet. Examples are multivitamins, Vitamin C, Vitamin B Complex, Evening Primrose Oil and Omega 3 Fish Oil.

2.3

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 3. The functional claims acceptable for health supplements are dependant on the vitamin and mineral content of the product. Functional claims acceptable for health supplement products are listed in Annex 4.

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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 a locally incorporated company with a permanent address in Malaysia. If the applicant is not the product owner, it should be authorized in writing by the product owner to be the holder of the product registration certificate and be responsible for all matters pertaining to the registration of the product. The applicant, thus becomes the marketing authorization holder and must assume responsibility for the quality, safety and efficacy of the product.

3.2

Quest2 Online System 3.2.1 What is the Quest2 Online Submission System? The Quest2 Online System is a an integrated and computerised system used by the National Pharmaceutical Control Bureau which enables the Product Licence Holder, Manufacturer, Importer and other related users to conduct a secured online transaction for the purpose of product registration, renewal of registration, change of manufactuirng 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. For details on how to apply for the Smart Card System, please refer to Annex 5.



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3.3

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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 page are compulsory.

3.5

Admin Information Documents required for this section are:

• • • • • • • •

For Local Products Batch Manufacturing Formula In Process Quality Control Finished Product Specification Stability Data Label (Mock Up) for immediate Container Label (Mock Up) for outer Carton Good Manufacturing Practices (GMP) Protocol of Analysis Certificate of Analysis

• • • • • • •

• • • •

For Imported Products Batch Manufacturing Formula In Process Quality Control Finished Product Specification Stability Data Label (Mock Up) for immediate Container Label (Mock Up) for outer carton Certificate of Free Sale (CFS) Good Manufacturing Practices 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. On 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” on 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 payable to “Biro Pengawalan Farmaseutikal Kebangsaan” in the form of a bank draft or money order .



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The total fee for a traditional product is RM1,200 while for health supplements it is RM2,200. For a health supplement products containing two or more active ingredients, the fees are 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). 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 6 for an example of import permit. 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 Quest2 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 4 separate containers with total contents of not less



• •

•

For Imported Products Import permit A minimum quantity of 4 separate containers with total contents of not less than 50gms Samples must be in their 4

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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• •

•

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than 50gms 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

• •

•

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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

APROVAL 5.1

Lead time for product registration For traditional and health supplement products, the evaluation process generally takes about 6 months.

5.2

Result of Testing The result of testing will be notified via the Quest2 System.

5.3

Market Placement A product cannot be placed in the market until you get the registration number which starts with the words ‘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 relased onto the market.



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Flow chart for the stages of registration under the Quest2 System

Stage 1

Stage 2

Apply for Digicert Smart Card System (Quest2)

Submit documentation via Quest2 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 belladonna 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)



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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.

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* 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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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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

Badak Kerbau

3.

Tapir Tapirus Indicus

4.

Banteng

Badak Chipan, Badak Tampong Banteng, Sapi, hutan

Bos banteng 5.

Siamang

Siamang Hylobates syndactylus

6.

Agile Gibbon

Wak-wak Hylobates agilis

7.

White-handed Gibbon

Ungka Hylobates lar

8.

9.

Scaly anteater or Pangolin

Tenggiling Manis javanica

Malayan wild Dog

Serigala, Anjing hutan Cuon alpines

10.

Clouded Leopard

Harimau dahan Neofelis nebulosa

11.

Marbled Cat

Kucing dahan Felis marmorata

12.

Flat-headed Cat

Kucing hutan Felis planiceps

13.

Golden Cat

Kucing tulip Felis temminckii

14.

Linsang

Linsang Prionodon linsang

15.

Binturong or Bear-cat

Binturong Artictis binturong

16.

Slow Loris

Kongkang, kera duku Nyticebus caucang

17.

Otter civet

Musang memerang Cynogale bennettii

18.

Derby’s Banded Civet

19.

Yellow-throated



Hemigalus derbyanus Martes flavigula

Musang belang Mengkira 16

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20.

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

34.

Malayan Flying Lemur

Cynocephalus



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

Tupai terbang kotor

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. 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

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

Rusa Cervus unicolor Kijang equines Napoh Munctiacus muntjak Pelandok Tragulus napu Harimau belang Tragulus javanicus Harimau bintang, Pantheratigris Harimau kumbang 7. Malayan Honey-Bear Panthera pardus Beruang 8. Wild pig Helarctos malayanus Babi hutan 9. Bearded pig Sus scrofa Babi bodoh Sus barbatus Part III : Binatang-binatang liar lain yang diperlindungi (Other protected wildlife)

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

Version 1.0 Dated 08 July 2009

THIRD SCHEDULE COMPLETELY PROTECTED WILD BIRDS

No

Name

Family

English Name

Scientific 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



Malay Name

-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 Dated 08 July 2009

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

-Bat Hawk

-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

-Microhierex caerulescens -Falco peregrines

-Lang Rajawali

15.

Pheasants, partidges

Phansianidae

-Red-breasted Falconet -Peregrine Falcon -Kestrel -Long-billed Partridge -Black Wood Partridge -Roulroul -Chestnutbreasted Partridge -Malay Peacock Pheasant -Rothschild’s -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

-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



Version 1.0 Dated 08 July 2009

-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 Dated 08 July 2009

-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 Dated 08 July 2009

-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 Dated 08 July 2009

-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.

Minivets and greybirds

Campephagidae

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

Version 1.0 Dated 08 July 2009

Tephrodornis gularis

-Pericrocotus flammeus

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

-Pycnonotus melanoleucos -Pycnonotus atriceps

-Merbah Tandok Burung Siam

-Pycnonotus dispar

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

-Coracina striata -Lalage nigra -Percrocotus roseus -Pericrocotus solaris

-Mountain Minivet -Scarlet Minivet 40.

Bulbuls

Pycnonotidae

-Black-andwhite Bulbul -Black-headed Bulbul -Black-crested Yellow Bulbul -Scalybreasted Bulbul -Large Olive Bulbul -Scrub Bulbul -Crested Bulbul -Mountain Streaked Bulbul

-Pycnonotus squamatus -Pycnonotus plumosus -Criniger bres -Criniger ochraceus -Hypsipetes moclellandi -Hypsipetes flavalus

-Burung Tuar

-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

-Dicrurus annectans

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

-Dicrurus aeneus

-Burung Paha Kelati -Dicrurus remifer -Burung Chawi -Dicrurus paradiseus Chawi -Burung Cha Hamba Kera 25

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

-Black-naped Oriole -Malaysian Black-headed Oriole

-Oriolus chinensis

-Burung Kunyet -Oriolus xanthonotus Besar -Burung Kunyet Kecil -Crested Malay -Platylophus -Burung galericulatus Menjerit Jay -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 -Merbah -Rhipidura albicollis -WhtieGila throated Gunung Fantail Flycatcher -Rhipidura javanica -Pied fantail Flycatcher -Merbah -Muscicapa grandis -Niltava Gila -Burung -Muscicapa sibirica -Siberian Kubung Flycatcher -Muscicapa unicolor Padi -Pale Blue Flycatcher -Muscicapa turcosa -Malaysian Blue -Muscicapa Ticellae Flycatcher -Tickell’s Blue -Kelicap -Muscicapa Flycatcher banyumas Ranting -Hill Blue -Muscicapa Flycatcher narcissina -Narcissus - Philentoma vilata Flycatcher -Merbah -MaroonBatu breasted -Murai -Terpsiphone Flycatcher paradise Ekor -Paradise -Terpsiphone Gading Flycatcher atrpcaudata -Murai -Japanese Paradise -Murai -Pachycephala Flycatcher Bakau cinerea -Magrove Whistler -Rail babler

-Eupetes macrocerus

-Striped Babler

Version 1.0 Dated 08 July 2009

-Burung Gemabala Kera 26

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products



Version 1.0 Dated 08 July 2009

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

-Pellorneum ruficeps -Trichastoma rostratum -Trichastoma abbotti

-Small Wren Babbler

-Napothera brevicaudata

-Pygmy Wren Babbler -Striped Tit Babbler

-Pneopyga Pusilla

-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

-Malacopteron magnum -Malacopteron cinereum -Malacoperon affine -Kenopia striata

-Macronus Gularis

-Stachyris leucotis

-Burung Terlanjor -Murai Belukar -Murai Rimba

-Burung Tua Pulih

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

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

-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 Dated 08 July 2009

-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 Besar -Enicurus -Burung schistaceus Tarom -Monticola Solitaria -Murai Belanda -Turdus obscures -Tiong Belacan -Myiophoneus coeruleus -Saxicola torquata -Zoothera sibirica -Motacilla cinerea -Anthus novaeseelandie -Motacilla indica -Motacilla flava

-Forest Wagtail -Yellow 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

-Scarletbacked Flowerpecker -Javan Firebreasted Flowerpecker -Plain Flowerpecker -Yellowthroated Flowerpecker -Hume’s Flowerpecker -Brownthroated Sunbird -Ruby-cheeked Sunbird -Purple-naped Sunbird -Van Hasselt’s Sunbird -Yellow-backed Sunbird -Scarlet Sunbird

55.

White-eye

Zosteropidae

56.

Starling

Sturnidae

57.

Sparrows and finches

Ploceidae



-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

Version 1.0 Dated 08 July 2009

-Dicaeum cruentatum -Dicaeum sanguinolentum

-Burung Sepah Putri -Burung Sepah Putri Gunung

-Dicaeum concolor -Prionochilus maculates -Dicaeum modestum

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

-Kelicap Mayang Kelapa -Kelicap Belukar -Kelicap Rimba

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

-Kelicap Jantong -Kelicap Pisang

-Arachnothera magna -Zosteropidae palpebrosa -Sturnus sturninus -Sturnus sinensis

-Kelicap Kunyit

-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

Version 1.0 Dated 08 July 2009

Annex 3 Claims Acceptable for Traditional Product No Categories General Health 1 Maintenance

• •

Indication Claims Traditionally used as a health supplement Traditionally used for general health Traditionally used for health and strengthening the body Traditionally used for relief of body heatiness Traditionally used for general debility, weakness after illness of childbirth Traditionally used for loss of appetite Traditionally used for difficulty in sleep Traditionally used for relief of fatigue Traditionally used as an aid to overcome fatigue during physical exertion Traditionally used to expel wind and invigorate vital energy Traditionally used to improve appetite Traditionally used for relieving waist ache and body weakness Traditionally used for relieving dizziness, sweating and difficulty in sleep Traditionally used for reducing body odour Traditionally used for reducing toothache

• • • • • • • • • • • • •

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 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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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

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

8

Men’s Health

• Traditionally used for energy and men’s health



• 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 heatiness

31

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

9

Skin



Version 1.0 Dated 08 July 2009

• 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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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

Annex 4 Functional Claims acceptable for Health Supplement No 1

Item Vitamin A

2

Vitamin C

3

Vitamin D

4

Vitamin E

5

Thiamine (Vitamin B1)

• Helps to maintain good health • Helps normal growth • Helps the body to metabolize carbohydrate

6

Beta Carotene

• Maintenance of good health • Helps in maintenance of growth, vision and tissue differentiation

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 • 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 tissue Claim for specific population subgroups; • elderly people who are confine indoors • Maintenance of good health

• Maintenance of good health • Helps in 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 • • • • •

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

• Maintenance of good health • Helps in formation of red blood cell

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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

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

• Maintenance of good health • Helps to metabolize fats and carbohydrates

16

Magnesium

• Maintenance of good health • Helps the body to metabolize carbohydrate

17

Iron

• Maintenance of good health • Helps in formation of red blood cell • Helps to prevent iron anaemia

18

Iodine

• •

Maintenance of good health Helps in the function of the thyroid glands

19

Zinc

• •

20

Copper

• •

Maintenance of good health Helps to metabolize carbohydrates, fats and protein Maintenance of good health Helps in formation of red blood cell

21

Manganese

• •



Maintenance of good health Helps the body to metabolize carbohydrates and protein

34

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

Annex 5 Quest2 Online Submission System How to access the Quest2 System? You must first register your membership particulars online at www.bpfk.gov.my. On the webpage, go to Quest2 main page

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

Figure 1: National Pharmaceutical Control Bureau Main Webpage



35

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

On the Quest2 main page, click on the “Sign up Now” menu.

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

Figure 2: Quest2 Main Page



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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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Fill up the Quest2 Membership and Registration Form to register your membership.

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

Figure 3: Quest2 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/CCM/Form 9



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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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After you have completed the registration form and select the appropriate package, click the “Submit Registration” button to go to the Payment Voucher.

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

Figure 4 : Step for Registration of Quest2 Membership You then select the payment method either money order, postal order or company cheque before you submit the application online.



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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

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Once you have submitted online, you are required to print the membership registration slip by clicking at “Print Membership Slip” button.

Source

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

Send the Membership Slip together with the following documents: 1. Copy of the identity card of the applicant (front only); 2. Letter of authorization from the company authorising the applicant; 3. Company/CCM/Form 9; and 4. Payment in money order, postal order or company cheque. To: Digicert Sdn Bhd, No. 20-22, Jalan 14/155B, 57000 Kuala Lumpur. Payment for the Smart Card System must be made to Digicert Sdn Bhd. For more information, please log on to www.bpfk.gov.my/body_1sttime_user.htm After clearance of payment, Digicert Sdn Bhd will mail you the login name and password to enter the Quest2 System together with the smartcard reader package. You have to install the smart card system into your computer. Once completed, you can enter the Quest2 System using the login and the password given.



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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

Go to the www.bpfk.gov.my/ webpage, and click on the Quest2 System main page. Enter your correct login name and password.

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

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. 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 / 03-89943066 or email at [email protected]



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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

Annex 6 Example of Import Permit



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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

Example of application letter for import permit

References: 1. National Pharmaceutical Control Bureau www.bpfk.gov.my 2. Department of Wildlife and National Park www.wildlife.gov.my



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BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 Dated 08 July 2009

For further information, please contact: Vice President, Facilitation Unit Client Support Services 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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