Health Supplement

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

<GP/BOD/OPERATIONSERVICES/REG001>
Dec 2011 Revision
AUTHORS: ROZITA ISHAK JUNAINAH MOHAMAD
Please note that the information contained herein is intended to be used for guidance and knowledge only. Whilst every effort has been taken to ensure the accuracy and completeness of the contents at the time this Guidance Paper is issued, inaccuracies may exist due to several reasons including changes of circumstances and/or amendments brought about due to a change in the policy (s) or prevailing rules or regulation. BiotechCorp does not hold out, warrant or guarantee that the reliance on the information contained herein will result in the granting or approval of the matters applied for. BiotechCorp welcomes feedback and comments on this document Feedback and comments can be sent to info@biotechcorp.com.my and by stating clearly in the subject line the document title and document Reference No.
Table of Contents
Pages
1 OBJECTIVE AND INTRODUCTION ................................................................................ 1
1.1 Objectives ....................................................................................................................... 1 1.2 Introduction .................................................................................................................... 1

2 OVERVIEW ON REGISTRATION OF TRADITIONAL & HEALTH SUPPLEMENT PRODUCTS ..................................................................................................................... 1
2.1 What is traditional product .............................................................................................. 1 2.2 What is health supplement product ................................................................................. 2 2.3 What is homeopathy product.. 2 2.4 Acceptable Claims for traditional & health Supplement product ................................... 2
3 GUIDELINES ON REGISTRATION OF TRADITIONAL & HEALTH SUPPLEMENT....... 2
3.1 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
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
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.
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.
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
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. Step 1 : Product Validation; and Step 2 :(Part 1) Submission of administration data and product information.
3.4
Product Validation All fields in product validation section are compulsory; I. Product Name To enter product name, dosage form and strength. 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. 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
II.
III.
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. Any porcine material (Yes / No) 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. Product Classification The application form displayed at Step 2 will depend on the type of product classification chosen. Traditional and health supplement product will only require to submit information under Part1. For traditional products, pick from the list displayed; - Traditional - Homeopathy - Dietary supplements / food supplements
V. VI.
VII.
3.5
Administrative Data and Product Information Section A: Product Particulars I. Product description Briefly state the visual and physical characteristic of the product including the shape, size, colour, odour, taste, consistency, type of table coating, etc.
II.
Indication / Usage Only indication allowed for traditional and health supplement can be made. Dose / Use Instruction Contraindication Warnings and Precautions Drug Interactions Side Effect or Adverse Reactions Signs and Symptoms of Overdose and Treatment Storage Condition
III. IV. V. VI. VII. VIII. IX.
X. XI.
Shelf Life 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. 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. 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. Attachment of Finished Product Quality Specification Provide details of quality control specifications including a list of tests and state the limits of acceptance. Stability Data
II.
III.
IV.
V.
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 distributors 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
Label (Mock Up) for immediate Container Label (Mock Up) for outer Carton Good Manufacturing Practice Certificate (GMP) Protocol of Analysis Certificate of Analysis
Label (Mock Up) for immediate Container Label (Mock Up) for outer carton Certificate of Free Sale (CFS) Good Manufacturing Practice Certificate (GMP) Letter of Authorisation from Product Owner Letter of Appointment of Contract Manufacturer from Product Owner Letter of Acceptance from Contract Manufacturer Protocol of Analysis 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. 4 SAMPLE SUBMISSION For traditional products, once the NPCBs 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 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
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.
Flow chart for the stages of registration under the Quest3 System
Stage 1
Apply for Digicert Smart Card System (Quest3)
Stage 2
Submit documentation via Quest3 System (online)
Step 1
Product Validation
Step 2
Part 1: Submit Administration Data & Product Information
Application Evaluated by the NPCB assessor
Sample Submission
Approval
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)
10
(ii) Botanicals (& botanical ingredients) which are banned Reported to cause. -Liver toxicity Botanicals 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
11
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 Oval leaf Dutchmans pipe
Aristolochia acuminata Lam Syn . Aristolochia tagala Champ Aristolochia Griseb Aristolochia bracteolate Retz Aristolochia chilensis Bridges in Lindl. Aristolochia cinnabarina C.Y. Cheng & J.L Wu Aristolochia clematitis L. Aristolochia contorta Bunge
Ukulwe
Birthwort Ma dou ling Tian xian teng Mil homes Ma dou ling Tian xian teng Qing mu xiang Sei-mokkou (Japanese) Birthwort Long birthwort
Aristolochia cymbifera Mart. Zucc. Aristolochia debilis Siebold & Zucc. Syn. Aristolochia longa Thunb. Syn. Aristolochia recurvilabra Hance Syn. Aristolochia sinarum Lindl.
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)
12
Aristolochia fimbriata Cham Aristolochia indica L. Aristolochia kaempferi Willd. Syn. Aristolochia chrysops (Stapf) E.H Wilson ex Rehder Syn. Aristolochia feddei H. Lv. 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 Aristolochia macrophylla Lam. Syn. Aristolochia siphon LHr. Aristolochia manschuriensis Kom. Syn. Hocquartia manshuriensis (Kom.) Nakai Syn. Isotrema manchuriensis (Kom.) H. Huber 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 Indian birthwort Yellowmouth Dutchman;s pipe
Dutchmans-pipe Manchurian Birthwort Manchurian Dutchmans pipeGuang mu tong Kan-Mokutsu (Japanese) Mokuboi (Japanese) Kwangbanggi (Korean)
13
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 Asarum himalaicum Hook. f. & Thomson ex Klotzsch or Asarum himalaycum Hook. f. & Thomson ex Klotzsch Asarum splendens (F. Maek.) C.Y. Cheng & C.S. Yang 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) Wild ginger Indian ginger Canada snakeroot Fals coltsfoot Colic root Heart snakeroot Vermont Snakeroot Southern snakeroot
Tanyou-saishin (Japanese)
Do-saishin (Japanese)
14
List B Botanicals which may be adulterated with Aristolochic Acid Botanical Name* Akebia spp. Common or Other Names Akebia Mu tong Ku mu tong Zi mutong Bai mu tong Mokutsu (Japanese) Moktong (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 Usuba-saishin (Japanese) Chinese wild ginger Xi Xin Hua Xi Xin Manchurian wild ginger Siebolds wild ginger
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. 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. Clematis spp.
Clematis Mufangji Clematidis Ireisen (Japanese) Wojoksum (Korean) Armands clematis Chuan mu tong (stem) Xiao mu tong Armands virgin bower
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. Clematis hexapetala Pall.
Chinese clematis Wei ling xian (root)
15
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. Lv. & Vaniot Syn. Clematis floribunda (Hayata) Yamam Syn. Clematis gagnepainiana H.Lv. & Vaniot Syn. Clematis leiocarpa Oliv. Syn. Clematis ovatifolia T. Ito ex Maxim. Syn. Clematis uncinata var. biternata W.T.Wang Syn. Clematis uncinata var. coriacea Pamp. Syn. Clematis uncinata var. Floribunda Hayata. Syn. Clematis uncinata var. ovatifolia (T. Ito ex Maxim.) Ohwi ex Tamura Syn. Clematis uncinata var. taitongensis Y.C. Liu 7 C.H. Ou
Cocculus spp. Cocculus carolinus (l.) DC. Syn. Cebatha carolina Britton Syn. Epibaterium carolinum (L.) Britton Syn. Menispermum carolinum L. Cocculus 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. Lv. Cocculus leaebe DC. Cocculus madagascariensis Diels Syn. Cocculus diversifolius DC.
Cocculus
Indian cockle
16
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. Cocculus palmatus (Lam.) DC. 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 Cocculus thunbergii DC. Diploclisia affinis (Oliv.) Diels. Syn. Diploclisia chinensis Merr. Syn. Cocculus affinis Oliv. Diploclisia chinensis Merrill Manispernum dauricum Saussurea lappa (Decne.) Sch. Bip.
Moku-boui (Japanese)
Columba Columbo
Cocombo
Xiangfangchi
Mokkou (Japanese)
17
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. Stephnia tetrandra S.Moore
Stephania Fen fsng ji, fang ji Fang ji (root) Hang fang ji Kanboi (Japanese) Hanbanggi (Korean) Fun-boui (Japanese) Sen-mokkou
Vladimiria souliei (franch) Ling
18
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 2. English Name Javan Rhinoceros Sumatran Rhinoceros Scientific Name Rhinoceros sondaicus Didermocerus sumatrensis Tapirus Indicus Malay Name Badak Raya Badak Kerbau Badak Chipan, Badak Tampong
3.
Tapir
4. 5. 6. 7. 8.
Banteng Siamang Agile Gibbon White-handed Gibbon Scaly anteater or Pangolin Malayan wild Dog Clouded Leopard Marbled Cat Flat-headed Cat Golden Cat Linsang Binturong or Bear-cat Slow Loris Otter civet Derbys Banded Civet
Bos banteng Hylobates syndactylus Hylobates agilis Hylobates lar Manis javanica
Banteng, Sapi, hutan Siamang Wak-wak Ungka Tenggiling
9. 10. 11. 12. 13. 14. 15. 16. 17.
Cuon alpines Neofelis nebulosa Felis marmorata Felis planiceps Felis temminckii Prionodon linsang Artictis binturong Nyticebus caucang Cynogale bennettii
Serigala, Anjing hutan Harimau dahan Kucing dahan Kucing hutan Kucing tulip Linsang Binturong Kongkang, kera duku Musang memerang
18.
Hemigalus derbyanus
Musang belang
19
19. 20. 21. 22. 23.
Yellow-throated Marten Weasel Long-tailed porcupine Serow Selangor Pigmy Flying Squirrel Red-cheeked Flying Squirrel Grev-cheeked Dlying
Martes flavigula Mustela nudipes Trichys lipura Capricornis sumatrensis Petaurillus kinlochii
Mengkira Pulasna Landak padi Kambing gurun, Tupai terbang terkecil
24.
Hylopetes spadiceus
Tupai terbang pipi merah
25.
Hylopetes Lepidus
Tupai terbang squirrel pipi kelabu Tupai terbang berjambang Tupai terbang squirrel dada putih Tupai terbang squirrel kecil Tupai terbang ekor merah
26.
Whiskered Flying squirrel White-Bellied Flying Vordemanns Flying Horsfields Flying Squirrel Smoky Flying squirrel Large Black Flying Squirrel Red Giant Flying Squirrel
Petinomys genebarbis
27.
Petinomys setosus
28.
Petinomys vordermanni
29.
Lomys horsfieldii
30. 31.
Pteromyscus pulverulentus Aeromys tephromelas
Tupai terbang kotor Tupai terbang hitam
32.
Petaurista Petautista
Tupai terbang merah
33.
Spotted Giant Flying
Petaurista elegant
Tupai terbang squirrel bintang Kubong
34.
Malayan Flying Lemur
Cynocephalus
20
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. 7. 8. 9. Sambur Deer Barking Deer Large Muose-Deer Lesser Muose-Deer Tiger Leopard Malayan Honey-Bear Wild pig Bearded pig Cervus unicolor equines Munctiacus muntjak Tragulus napu Tragulus javanicus Pantheratigris Panthera pardus Helarctos malayanus Sus scrofa Sus barbatus Rusa Kijang Napoh Pelandok Harimau belang Harimau bintang, Harimau kumbang Beruang Babi hutan Babi bodoh
Part III : Binatang-binatang liar lain yang diperlindungi (Other protected wildlife) 1. 2. 3. 4. 5. 6. 7. 8. Hairy-nosed Otter Smooth Otter Common Otter Small-clawed Otter Common Palm Civet Malay Civet Short-tailed Mongoose Small Indian Mongoose Indian Grey Mongoose Leopard Cat Pig-tailed Macaque Malayan Porcupine Malayan Flying Fox Crocodile Python Water monitor Clouded monitor Dumerils Monitor Lutra sumatrana Lutra perspillata Lutra lutra Amblonyx cinerea Paradoxurus hermaphrodites Viverra tangalunga Herpestes branchyurus Herpeteses auropunctatus Herpestes edwardsii Felis bengalensis Macaca nemesrina Hystrix brachyuran Pteropus vampyrus Crocodylus porosus Python reticulates Varanus salvator Veranus nebulosus Varanus dumeril Memerang hidung Memerang licin Memerang utara Memerang kecil Musang pulut Musang tenggalong Bambun ekor pendek Cheperlai,bambun kecil
9. 10. 11. 12. 13. 14. 15. 16. 17. 18.
Bambun kelabu Kucing Batu Berok Landak raya Kluang Buaya Tembaga Ular Sawa Biawak air Biawak tikus Biawak kudong
21
THIRD SCHEDULE COMPLETELY PROTECTED WILD BIRDS
No 1. 2. 3. 4.
Name Grebes Petrels Tropic Birds Pelicans
Family Podicipididae Hydrobatidae Phaethontidae Pelecanidae
English Name -Little Grebe -Wilsons Storm Petrel -Short-tailed Tropic Bird -White Pelcian
Scientific Name -Podiceps ruficollis -Oceanitis Occeanicus -Phaeton aethereus -Pelecanus onocrotalus -Sula leocogaster
Malay Name
-Undan Putih -Dendang laut -Dendang air -Burung kosa -Burung Simbang Pulau
5.
Grannets & boobies Cormorants
Sulidae
-Brown booby
6.
Phalacrocoracidae
-Common Cormorant -Darter -Christmas Island Frigatebird -Dusky-grey Heron -Cattle Egret
-Phalcrocorax carbo
7. 8.
Darters Frigate Birds
Anhingidae Fregatidae
-Anhinga anhinga -Fregata andrewsi
9.
Herons
Ardeidae
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 -Storms Stork -Ciconia stormi Upeh -Lesser -Leptoptilos Adjuntant Stork javanicus -Burung Botak -White Ibis -Threskiornis -Burung aethiopica Sekendi
-Ardae sumantrana
22
12.
Hawks and Eagles
Accipitridae
-Bat Hawk
-Machaerhamphus alcinus -Crested -Pernis Honey Buzzard ptilorhynchus -Black Eagle -Ictinaetus malayensis -King Vulture -Torgos calvus -Long-billed Vulture -White-backed Vulture -Gyps indicus
-Pseudogyps bengalensis
-Marsh Harrier -Short-toed Eagle
-Circus aeruginosus -Circaetus gallicus
-Lang Malam -Lang Lebah -Lang Hitam -Burung Hereng -Burung Hereng Paroh Panjang -Burung Hereng Belakang Putih -Lang Kepala Putih -Lang Jari Pendek
13.
Osprey
Pandionidae
-Osprey
-Pandion haliaetus
-Lang Tiram -Lang Rajawali
14.
Falcons
Falconidae
15.
Pheasants, partidges
Phansianidae
-Red-breasted Falconet -Peregrine Falcon -Kestrel -Long-billed Partridge -Black Wood Partridge -Roulroul -Chestnutbreasted Partridge -Malay Peacock Pheasant -Rothschilds -Great Argus -Green Peafowl
-Microhierex caerulescens -Falco peregrines -Falco tinnunculus -Rhizothera longirostris -Melanoperdix nigra -Rollulus roulroul -Arborophilia charlaeni -Polyplectron Malacensis -Rheinartia Ocellata -Agusianus argus -Pavo muticus
-Burung Selanting -Burung Bertam -Burung Siul -Sang Serok
16.
Cranes
Gruidae
-Eastern Sarus Crane
-Grus antigone
-Merak Pongsu -Kuang Raya Gunung -Kuang Raya -Merak -Burung Keria
23
17.
Rails, Crakes & gallinules
Rallidae
-Purple Coot -Masket Finfoot
-Porphyrio Porphyria -Heliopais personata -Hydrophasianus Chirurgus -Metopidius indicus -Chlidonias leucoptera -Sterna hirundo -Sterna doughalli
-Panglin -Burung Pedendeng -Burung Teratai
18.
Jacanas
Jacanidae
19.
Gulls & terns
Laridae
-Pheasanttailed Jacana -Bronzeweiged Jacana -White-winged Black Tern -Common Tern -Roseate Tern
-Little Tern -Crested Tern
-Sterna albifrons -Sterna bergii
-Common Noddy 20. Pigeons & Doves Columbidae -Nicobar pigeon -Pied Imperial Pigeon -Mountain Imperial Pigeon -Red Turtle Dove -Lesser Hawk Cuckoo -Hawk Cuckoo
-Anous stolidus
-Chamar Sayap Putih -Chamar -Chamar Jambu -Chamar Kecil Chamar Berjambul -Chamar Hitam -Merpati Mas -Rawa -Pergam Bukit
-Coloenas nicobarica -Ducula bicolour -Ducula badia -Streptopelia tranquebarica
21.
Cukcoos
Cuculidae
-Cuculus vagans -Cuculus fugax
-Banded Bay Cukcoo -Koel -Lesser Green-billed Malcoha -Large Greenbilled Malcoha -Raffless Malcoha
-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
24
22.
Typical owls
Strigidae
-Collared Scops Owl -Scops Owl -Reddish Scops Owl -Malay Eagle Owl -Fish Owl -Pygmy Owlet
-Otus bakkamoena -Otus scops -Otus rufescens -Bubo sumatranus -Bubo ketupu -Glaucidium brodiei
-Burung Jampok -Burung Hantu
-Spotted Wood Owl 23. Barn Owls Tytonidae -Barn Owl -Bay Owl
-Strix seluputo
-Burung Punggok Kechil -Burung Charekkafan -Burung Punggok Api -Burung Segan
24.
Frogmounths
Podargidae
-Large Frogmouth -Blyths Frogmouth -Malaysian Eared Nightjar -Long-tailed Nightjar -Migratory Nightjar -Giant Swiftlet -Grey-rumped Swiftlet -White-bellied Swiftlet -Malaysian Spinetail Swift -Migrant Swift -Crested Tree Swift
-Batracostomus auritus -Batrachostomus affinis -Eurostopodus temmincki -Caprimulgus macrurus -Caprimulgus indicus -Collocalia gigas -Collocalia fuciphaga
25.
Nightjars
Carprimulgidae
-Burung Taptibau -Burung Kuber -
26.
Swifts
Apodidae
27.
Tree Swift
Hemiprocnidae
28.
Trogons
Trogonidae
-Whitewhiskered Tree Swift -Red-naped -Harpactes kasumba Trogan -Diards -Harpactes Trogon Tragon -Orange-Harpacted oreskios breasted Trogon
-Layanglayang Gua -Collocalia esculenta -Layang padi -Chaetura gigantean -Layanglayang -Apus pacificus besar -Hemiprocne -Layanglongipennis layang Berjambol -Hemiprocne comate
-Burung Kesumba
-Burung Gembala Rimau
25
29.
Kingfishers
Alcedinidae
-Common Kingfisher -Blue-banded Kingfisher -Brown-winged Stork-billed Kingfisher -White-collared Kingfisher -Bay-haeaded Bee-eater -Blue-throated Bee-eater -Burmese Roller -Broad-billed Roller -Hoopoe -White-crested Hornbill -Bushy-crested Hornbill -Blyths Hornbills -Pied Hornbills -Rhinoceros Hornbill -Great Hornbill
-Alcedo atthis -Alcedo auryzona -pelargopsis amauroptera -Halcyon concreata
-Pekaka Chitchit -Pakaka Bukit -Burung Buaya
30.
Bee-eaters
Meropidae
31.
Rollers
Crocidae
-Raja Udang -Merops leschenaulti -Berekberek -Merops viridis -Rengkok Biru -Coracias benghalensis -Eyrystomus -Tiong Batu orientalis -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 -indicator archipelagus -Musoh Lebah
31. 32.
Hoopoe Hornbills
Upupide Bucerotidae
33.
Barbets
Capitonidae
-fire-tufted Barbet -Manycoloured Barbet -Little Barbet -Brown Barbet -Malay Honeyguide
34.
Honey-guide
Indicaoridae
26
35.
Woodpeckers
Picidae
36.
Broadbills
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
-Picumnus innominatus -Picus virdanus -Picus vittatus -Picus miniaceus -Dinipium rafflesi
-Pelatok Belang -Pelatok -Pelatok Hijau -Pelatok Merah -Pelatok Rimba -Pelatok Gajah -Pelatok Punggor -Pelatok Buluh -Burung Takau -Burung Hujanhujan -Burung Rakit
-Mulleripicus pulverulentus -Blythipicus ribiginosus -Gecinulus grantia
-Calyptomena viridis -Psarisomus dalhousiae -Cybirhynchus macrorhynchos -Corydon sumtranus
37.
Pittas
Pittidae
-Giant Pitta -Garnet Pitta
-Pitta caerulea -Pitta granatina
-Blue-tailed Pitta
-Pitta guajana
-Pitta sordid -Hooded Pitta
-Burung Pachat -Burung Pachat Kepala Merah -Burung Pachat ekor Biru -Burung Gembala Pelandok
38.
Swallows and martins
Hirundinidae
-House Martin -Barn Swallow -Pacific Swallow -Red-rumped Swallow
-Delichon urbica -Hirundo rustica -Hirundo tahitica -Hirundo striolata
-Layanglayang Gua
27
39.
Minivets and greybirds
Campephagidae
-Hook-billed Greybird -Barref Greybird -Pied Triller -Ashy Minivet
Tephrodornis gularis -Coracina striata -Lalage nigra -Percrocotus roseus
-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 -Ashy Bulbul 41. Leafbirds and Fairy Irenidae -Common Lora -Lesser Green Leafbird
-Pericrocotus solaris -Pericrocotus flammeus -Pycnonotus melanoleucos -Pycnonotus atriceps -Pycnonotus dispar -Pycnonotus squamatus -Pycnonotus plumosus -Criniger bres -Criniger ochraceus
-Merbah Rimba -Punai Rimba -Kuang Kuit -Burung Chok Padang -Burung Mata Hari
-Merbah Tandok Burung Siam -Merbah Kunyit -Merbah Bersisik -Murai Rimba -Burung Rabah -Merbah Berjanggut -Burung Barau Bukit
-Hypsipetes moclellandi -Hypsipetes flavalus
-Aeghitina tiphia -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 -Dicrurus aeneus
-Burung Tuar -Kelichap Kunyit -Burung Daun Besar -Burung Daun Kecil -Murai Gajah -Chechawi
-Burung Paha Kelati -Dicrurus remifer -Burung Chawi -Dicrurus paradiseus Chawi BurungCha Hamba Kera
28
43.
Orioles
Oriolidae
-Black-naped Oriole -Malaysian Black-headed Oriole
44.
Crows and jays
Corvidae
45. 46.
Titmice Nuthatches
Paridae Sittidae
47.
Flycatchers
Muscicapidae
-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 -Tickells 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
-Oriolus chinensis
48.
Bablers
Timaliidae
29
-Striped Babler -Blyths Jungle Babbler -Abotts Jungle Babbler -Graeter Redheaded tree Babbler -Lesser-Redheaded Tree Babbler -Plain Bubbler -Striped Wren Babbler
-Pellorneum ruficeps -Trichastoma rostratum -Trichastoma abbotti -Malacopteron magnum -Malacopteron cinereum -Malacoperon affine -Kenopia striata
-Burung Terlanjor -Murai Belukar -Murai Rimba -Burung Tua Pulih
-Napothera brevicaudata
-Small Wren Babbler -Pygmy Wren Babbler -Striped Tit Babbler -Fluffy-backed Tit Babbler -White-eared Tree Babbler -Golden Tree Babbler -Silver-eared Mesia -Cutia -Common Nun Babbler -White-beilled Crested Babbler -White-headed Babbler -Long-tailed Sibia
-Pneopyga Pusilla -Macronus Gularis
-Macronus ptilosus -Stachyris leucotis
-Stachyris chrysea -Leiothrix argentauris -Cutia nepalensis -Alcippe poiocephala -Yuhina zantholeuca
-Burung Resam -Merbah Sampah Kuning -Burung Pong-pong -Kelicap Bunga Kantan -Kelicap Mas
-Murai Sampah -kelicap Berjambul
-Gamsorhynchus rufulus -Heterophasia picaoides
30
49.
Warblers
Sylviidae
-Fly-eater -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 -Richards Pipit
-Gerygone fusca -Cristicola juncidis -Phylloscopus trivirgatus -Phylloscopus occipitalis -Locustella lanceolata -Seicercus superciliaris -Prthotomus atrogularis -Luscinia cyane
-Kelicap Perepat -Burung Laki Padi
-Burung Tikus -Kelicap Buluh -Kelicap Pucat Pisang
50.
Thrushes
Turdidae
-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 -Mentua Pelandok -Burung Apit-apit
51.
Wagtails and pipits
Motacilidae
52.
Shrikes
Laniidae
-Anthus novaeseelandie -Forest Wagtail -Motacilla indica -Yellow -Motacilla flava Wagtail -Schach Shrike -Lanius schach -Brown Shrike -Lanius shrike -Thick-billed -Lanius tigrinus Shrike
-Burung Tirjup
31
53.
Flowerpeckers
Dicaeidae
54.
Sunbirds and spiderhunters
Nectariniidae
-Scarletbacked Flowerpecker -Javan Firebreasted Flowerpecker -Plain Flowerpecker -Yellowthroated Flowerpecker -Humes Flowerpecker -Brownthroated Sunbird -Ruby-cheeked Sunbird -Purple-naped Sunbird -Van Hasselts Sunbird -Yellow-backed Sunbird -Scarlet Sunbird -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
-Dicaeum cruentatum -Dicaeum sanguinolentum -Dicaeum concolor -Prionochilus maculates -Dicaeum modestum
-Burung Sepah Putri -Burung Sepah Putri Gunung
-Anthreptes malacensis
-Kelicap Mayang Kelapa -Kelicap Belukar -Kelicap Rimba
-Anthreptes singalensis -Nectarinia hypogrammica -Nectarinia sperata -Aethopyga siparaja -Aethopyma mystacalis -Arachnothera longirostris -Arachnothera chrysogenys -Arachnothera magna -Zosteropidae palpebrosa -Sturnus sturninus -Sturnus sinensis -Ampeliceps coronatus -Aridotheres cristatellus -Erythrura prasina -Erythrura hyperthra -Pyrrhula nipalensis -Emberiza aureola
-Kelicap Jantong -Kelicap Pisang
55. 56.
White-eye Starling
Zosteropidae Sturnidae
-Kelicap Kunyit
57.
Sparrows and finches
Ploceidae
-Chiak Perut Merah
-Pipit Gunung
32
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)
33
Annex 4 Claims Acceptable for Traditional Product No Categories 1 General Health Maintenance 2 Blood & Body Fluid 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 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 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
Bone, Muscle & Joint
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
34
Cough & Cold
Traditionally used for relief of fever, cough and cold Traditionally used for relief of sore throat Traditionally used for reducing phlegm and relief cough, sore throat and body heatiness Traditionally used for relief of throat irritations and cough Traditionally used for relief nasal congestion Traditionally used for relief of sore throat and cough Traditionally used for relief of mouth ulcers due to heartiness Traditionally used to relieve sinusitis
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 Womens 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 ) Traditionally used for energy and mens health / for vitality
Mens Health
35
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
36
Annex 5 Functional Claims acceptable for Health Supplement No 1 Item Vitamin A 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 4 5 Vitamin E Thiamine (Vitamin B1) 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
Vitamin C
Vitamin D
Beta Carotene
Riboflavin (Vitamin B2)
Niacin (Vitamin B3)
Pyridoxine (Vitamin B6)
10
Cyanocobalamine (Vitamin B12)
Helps in maintenance of good health Helps in formation of red blood cell
37
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 Helps in maintenance of good health Helps to metabolize fats and carbohydrates Helps in maintaining of good health Helps to metabolized fats and carbohydrates 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 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
12
Biotin
13
Pantothenic Acid
14
Calcium
15
Phosphorus
16
Magnesium
17
Iron
18
Iodine
19
Zinc
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 A factor in maintenance of good health Helps the body to metabolize carbohydrates and protein Helps improve a beneficial intestinal microflora
20
Copper
21
Manganese
22
Probiotics
38
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.
39
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
40
Click at Guide for first-time registration Here you will be explained on how to register and fill up the registration memberslip form
Figure 2: Guide for first-time registration
41
Fill up the Quest3 Membership and Registration Form to register your membership.
Figure 3: Membership & Digital Certificate Registration Form
You are required to attach a scanned copy of the following documents on your membership registration form. 1. Copy of the identity card of the applicant (front only) 2. Letter of authorization from the company authorising the applicant 3. Company registration form
42
After you have completed the registration form, please select the appropriate package for the package of Digital Certification.
Figure 4: Package of Digital Certification The package are either package A, B or C and including USB token, guide manual and digital certificate for 1 or 2 years validity.
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Please read the terms of service before you make a declaration by accepted the notification of acceptance.
Figure 5: BPFK Quest3 Member Terms of Services Click at the column I have read and agree to the terms of service if you agree with the terms of services.
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After you have complete the registration form and declared the terms of service, click the submit registration button to go to BPFK Quest3 Membership Registration.
Figure 6: Submit the registration form Once you have submitted online, you are required to print the membership registration slip and click at Download slip button and make payment as instructed in the slip.
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Example of membership registration
Figure 7: BPFK Quest3 Membership Registration Slip Send the Membership Slip together with the following documents: 1. Copy of the identity card of the applicant (front only); 2. Authorised person signature (on membership registration slip)
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3. Copy of your companys letter authorisation; 4. Copy of Company Registration Form 5. Payment in money order or postal order. To: Digicert Sdn Bhd (457608-K), No. 3-20 & 3-22, Jalan Jalil Perkasa14, Aked Esplaned, Bukit Jalil, 57000 Kuala Lumpur. Tel: 03-89928888 Payment for the Smart Card System must be made to Digicert Sdn Bhd. You can make the payment by using either money order or postal order after you submit the application of Quest 3 via online. The USB token will be sent to you by POS LAJU within 7 working days upon receipt of payment to the company address specified in the form. Your password to logon to the system will be emailed to you at the email address specified in the form upon registration approval by BPFK. To begin your product registration application, go to the www.bpfk.gov.my/ webpage, and click on the Quest3 System main page. Enter your correct login name and password. You may start submitting your application online from there on.
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(ii) Existing Quest 2 User

Please go to main website NPCB and click at Quest 3 link.
Source: National Pharmaceutical Control Bureau Webpage (www.bpfk.gov.my)
Figure 8: National Pharmaceutical Control Bureau Main Webpage
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To access to the Quest3 system please click at registered user? Please click here
Figure 9: National Pharmaceutical Control Bureau Quest3 Webpage
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Key in the smart card pin number, and verify your identity by clicking at verify my identity
Figure 10: Verified your identity
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After you have verified your identity, the system required you to login the system.
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.
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 customercare@digicert.com.my
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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: info@biotechcorp.com.my
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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

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

1 OBJECTIVE AND INTRODUCTION ................................................................................ 1

1.1 Objectives ....................................................................................................................... 1 1.2 Introduction .................................................................................................................... 1

3.1 3.2 3.3 3.4 3.5 3.6

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

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

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

III. IV. V. VI. VII. VIII. IX.

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

In summary, the documents required for this section are:

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

Apply for Digicert Smart Card System (Quest3)

Submit documentation via Quest3 System (online)

Part 1: Submit Administration Data & Product Information

Application Evaluated by the NPCB assessor

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

-Not allowed in preparation for oral use

Dryabalanops aromatic & Borneolum syntheticum (contains camphor & borneol)

-Disturbance of the nervous system

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

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

Akebia trifoliate (thumb.) Koidz.

Chinese clematis Wei ling xian (root)

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011

Stephania spp. Stephnia tetrandra S.Moore

Vladimiria souliei (franch) Ling

BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products

Version 1.0 st Dated 1 Dec 2011