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 email@example.com 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 st Dated 1 Dec 2011 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 0
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products 1 Version 1.0 st Dated 1 Dec 2011 OBJECTIVES AND INTRODUCTION 1.1 Objectives The objective of this Guidance Document is to provide general guidance for the registration of traditional product and health supplement in Malaysia. This Guidance paper should be read inconjunction with the relevant sections of the Drug Registration Guidance Document September 2011 Revision produced by the National Pharmaceutical Control Bureau. In the event of any contradiction between the content of this document and any Guidance Document produced by the National Pharmaceutical Control Bureau or any written law, the latter shall take precedence. 1.2 Introduction Natural product discovery and commercialization is one of the focus areas in the National Biotechnology Policy – Trust 1: Agricultural Biotechnology Development. One of the requirements prior to the commercialization of natural products is for the product to be registered with National Pharmaceutical Control Bureau. The National Pharmaceutical Control Bureau (NPCB) is a bureau under the Ministry of Health, Malaysia, in charge of pharmaceutical regulatory matters. The main objective of the NPCB is to ensure the quality, safety and efficacy of products for the local market through a registration and licensing scheme. Products that are regulated by the NPCB include: Pharmaceuticals; Traditional and Health Supplements; Cosmetics; and Veterinary products. For more information, please log on to http://www.bpfk.gov.my 2 OVERVIEW ON REGISTRATION OF TRADITIONAL & HEALTH SUPPLEMENT PRODUCTS 2.1 What is traditional product? Traditional product is defined as any product used in the practice of indigenous medicine, in which the drug consists solely of one or more naturally occuring substances of a plant, animal or mineral or part thereof, in the unextracted or crude extract form and a homeopathic medicine. Source : Drug Registration Guidace Document, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Sept 2011Revision Note however that ingredients that fall under the prohibited plant or animal list are not allowed to be registered. 1
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 Please refer to Annex 1 and Annex 2 for the list of prohibited plants and animals respectively. 2.2 What is health supplement product? Health supplements shall mean products that are intended to supplement the diet taken by mouth in forms such as pills, capsules, tablets, liquids or powders and not represented as conventional food/sole item of a meal or diet. Health supplements may include ingredients such as vitamins, minerals, amino acids, natural substances of plant/animal origin, enzymes and substances with nutritional or physiological function. Source : Drug Registration Guidace Document, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Sept 2011Revision The maximum daily levels of vitamins and minerals allowed in health supplement products for adults are listed in Annex 3. 2.3 What is homeopathy product? Homeopathic medicine means any pharmaceutical dosage form used in the homeopathic therapeutic in which diseases are treated by use of minute amounts of such substances which are capable of producing in healthy persons symptoms similar to those of disease being treated. (Control of Drugs and Cosmetics Regulation 1984) 2.4 Acceptable Claims for traditional and health supplement product. For traditional products, the words “Traditionally used for” must be inserted in front of the claim. The claims allowed for traditional products are listed in Annex 4. The functional claims acceptable for health supplements are dependent on the vitamin and mineral content of the product. The indication allowed for health supplements are; used as health supplement, dietary supplement, food supplement or nutritional supplement. The indication for pregnant and lactating women would be “vitamin and mineral supplements for pregnant and lactating women”. Functional claims acceptable for health supplement products are listed in Annex 5. List of non permissible indications for natural products are listed in Annex 6. 3 GUIDELINES ON REGISTRATION OF TRADITIONAL & HEALTH SUPPLEMENT 3.1 Who can apply for product registration? The applicant for product registration must be registered with Suruhanjaya Syarikat Malaysia (SSM) or Malaysia Registrar of Business (ROB). If the applicant is not the product owner, it should be authorized in writing by the 2
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 product owner to be the holder of the product registration certificate and be responsible for all matters pertaining to the registration of the product. 3.2 Quest3 Online System The application for product registration must be submitted via online at http://www.bpfk.gov.my 3.2.1 What is the Quest3 Online Submission System? The Quest3 system is a new enhanced online system to replaced Quest2 system. It is an integrated and computerized system used by the National Pharmaceutical Control Bureau which enables the Product License Holder, Manufacturer, Importer and other related users to conduct a secured online transaction for the purpose of product registration, renewal of registration, change of manufacturing site and for application for variation of product particulars such as labelling, packaging sizes and claims. To access this system, you are required to have a User Digital Certificate which comes in a Smart Card System. There are 2 categories of Quest3 users; i) First time user ii) Existing Quest2 user Please refer to Annex 7 on details of how to access the Quest3 system. 3.3 How to register the traditional and health supplement product The application for product registration follows a 2-step process: i. ii. 3.4 Step 1 : Product Validation; and Step 2 :(Part 1) Submission of administration data and product information. Product Validation All fields in product validation section are compulsory; I. Product Name To enter product name, dosage form and strength. II. Dosage Form You may select from the given list. A tablet may be plain, chewable, coated (enteric, film, or sugar), dispersible, effervescent, extended release, sublingual, etc. III. Active Substance Substance name You may select substance from the search database. If it is not listed, it may be entered manually and will be added onto the list. Strength of substances 3
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 You may enter the content of active ingredients (numerical) and then select the weights and measures from the given list. IV. Excipient To indicate function of substance e.g sweetener, preservative, etc. V. Any porcine material (Yes / No) VI. Manufacturer You may select from the search data base. Details need to be submitted if you are new manufacturer. Please indicate if the manufacturer is a contract manufacturer or otherwise. VII. Product Classification The application form displayed at Step 2 will depend on the type of product classification chosen. Traditional and health supplement product will only require to submit information under Part1. 3.5 For traditional products, pick from the list displayed; - Traditional - Homeopathy - Dietary supplements / food supplements Administrative Data and Product Information Section A: Product Particulars I. Product description Briefly state the visual and physical characteristic of the product including the shape, size, colour, odour, taste, consistency, type of table coating, etc. II. Indication / Usage Only indication allowed for traditional and health supplement can be made. III. Dose / Use Instruction IV. Contraindication V. Warnings and Precautions VI. Drug Interactions VII. Side Effect or Adverse Reactions VIII. Signs and Symptoms of Overdose and Treatment IX. Storage Condition 4
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 X. Shelf Life XI. Therapeutic Code (is any) Applicants should indicate the WHO assigned ATC code for each distinct therapeutic indication proposed for a product, if such a code is available. Please choose from the list given at database. Section B: Product Formula I. Batch Manufacturing Formula Copy of batch manufacturing formula is required for this section. State the batch size and actual batch manufacturing master formula. II. Manufacturing process Briefly describe the manufacturing process starting from the raw material until finished product including the assembling part. If the product is repacked by another manufacturer, details of repacking and the quality control must be supplied. III. Attachment of In Process Quality Control Copy of In Process Quality Control during the production including the numbers of sample, frequency of sampling and specification for quality assurance of the product. IV. Attachment of Finished Product Quality Specification Provide details of quality control specifications including a list of tests and state the limits of acceptance. V. Stability Data Section C: Particulars of Packing I. II. III. IV. V. C1 : C2 : C3 : C4 : C5: pack size and fill details by weight, volume or quantity container type barcode no recommended distributor‟s price (not compulsory) recommended retail price (not compulsory) Section D: Label Mock up for Immediate Container, Outer Carton and Proposed Package Insert I. Attach the mock up label for immediate container, outer carton and proposed package insert if applicable. In summary, the documents required for this section are: For Local Products Batch Manufacturing Formula In Process Quality Control Finished Product Specification Stability Data For Imported Products Batch Manufacturing Formula In Process Quality Control Finished Product Specification Stability Data 5
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Label (Mock Up) for immediate Container Label (Mock Up) for outer Carton Good Manufacturing Practice Certificate (GMP) Protocol of Analysis Certificate of Analysis Version 1.0 st Dated 1 Dec 2011 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 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). 6
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 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 7
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products 5 Version 1.0 st Dated 1 Dec 2011 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. 8
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 Flow chart for the stages of registration under the Quest3 System Stage 1 Stage 2 Apply for Digicert Smart Card System (Quest3) Submit documentation via Quest3 System (online) Step 1 Step 2 Product Validation Part 1: Submit Administration Data & Product Information Application Evaluated by the NPCB assessor Sample Submission Approval 9
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 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
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 (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 11
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 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) 12
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 Aristolochia fimbriata Cham Aristolochia indica L. Aristolochia kaempferi Willd. Syn. Aristolochia chrysops (Stapf) E.H Wilson ex Rehder Syn. Aristolochia feddei H. Lév. Syn. Aristolochia heterophylla Hemsl Syn. Aristolochia mollis Dunn Syn. Aristolochia setchuenensis Franch Syn. Aristolochia shimadai Hayata Syn. Aristolochia thibetica Franch Syn. Isotrema chrysops Stapf Syn. Isotrema heterophylla (Hemsl.) Stapf Syn. Isotrema lasiops Stapf Aristolochia kwangsiensis Chun 7 F.C. How Syn. Aristolochia austroszechuanica C. B Chien & C. Y. Cheng Indian birthwort Yellowmouth Dutchman;s pipe Aristolochia macrophylla Lam. Syn. Aristolochia siphon L‟Hér. Aristolochia manschuriensis Kom. Syn. Hocquartia manshuriensis (Kom.) Nakai Syn. Isotrema manchuriensis (Kom.) H. Huber Dutchman‟s-pipe Manchurian Birthwort Manchurian Dutchman‟s pipeGuang mu tong Kan-Mokutsu (Japanese) Mokuboi (Japanese) Kwangbanggi (Korean) Aristolochia maurorum L. Aristolochia maxima jacq. Syn. Aristolochia maxima var. Angustifolia Duchartre in DC. Syn. Howardia hoffmanni Klotzsch Aristolochia mollissima Hance Aristolochia pistolochia L. Aristolochia rigida Duch. Aristolochia rotunda Linn. Aristolochia serpentaria L. Syn. Aristolochia serpentaria var. Hastate (Nutt) Duch. Aristolochia watsoni Wooton & Standley or Aristolochia watsonii Wooton & Standley Syn. Aristolochia porphyropyylla Pfeifer Aristolochia westlandii Hemsl. Or Aristolochia westlandi Hemsl. Virginia snakeroot Serpentaria Virginia serpentary 13
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 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) 14
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 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. 15
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Version 1.0 st Dated 1 Dec 2011 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. 16
BiotechCorp Guidelines on Registration of Traditional & Health Supplement Products Cocculus orbiculatus DC. Syn. Cissampelos pareira Linn. Cocculus orbiculatus (L.) DC. Syn. Cocculus cuneatus Benth. Syn. Cocculus sarmentosus (Lour.) Diels S
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 .
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