Registration of Traditional and Health Supplement

Transcription

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.
BiotechCorp
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
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
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
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
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
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
In Process Quality Control
Finished Product Specification
Stability Data



For Imported Products
In Process Quality Control
Finished Product Specification
Stability Data
5
BiotechCorp





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
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
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
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
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
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
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
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
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
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
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
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
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
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
Cocculus orbiculatus DC.
Syn. Cissampelos pareira Linn.
Cocculus orbiculatus (L.) DC.
Syn. Cocculus cuneatus Benth.
Syn. Cocculus sarmentosus (Lour.) Diels
Syn. Cocculus sarmentosus var. linearis
Yamam.
Syn. Cocculus sarmentosus var. pauciflorus
Y.C. Wu
Syn. Cocculus sarmentosus var.
stenophyllus Merr.
Syn. Cocculus thunbergii DC.
Syn. Cocculus trilobus (Thunb.) DC.
Syn. Menispermum orbiculatus L.
Syn. Menispermum trilobum Thunb.
Syn. Nephroia sarmentosa lour.
Moku-boui (Japanese)
Cocculus palmatus (Lam.) DC.
Columba
Columbo
Version 1.0
st
Dated 1 Dec 2011
Cocculus pendulus Diels
Syn. Cebatha pendua (J.R. & C. Forst.)
Kuntze
Syn. Epibaterium pendulus Forst. f.
Syn. Cocculus Epibaterium DC.
Cocclulus pendulus (Forst. & Forst) Diels.
Cocculus palmatus Hook.
Syn. Jateorhiza Miersii Oliver
Cocombo
Cocculus thunbergii DC.
Diploclisia affinis (Oliv.) Diels.
Syn. Diploclisia chinensis Merr.
Syn. Cocculus affinis Oliv.
Diploclisia chinensis Merrill
Xiangfangchi
Manispernum dauricum
Saussurea lappa (Decne.) Sch. Bip.
Mokkou (Japanese)
17
BiotechCorp
Sinomenium acutum (Thunb.) Rehder &
E.H. Wilson
Syn. Cocculus diversifolius var. cinereus
Diels
Syn. Cocculus heterophyllus hemsl. & E.H.
Wilson
Syn. Menispermum acutum Thunb.
Syn. Sinomenium acutum (Thunb.) Rehder
& E.H. Wilson
Var. cenereum (Diels) Rehder & E,H.
Wilson
Syn. Sinomenium diversifolium (Diels) Diels
Orientvine
Xunfengteng
Dafengteng
Daqingmuxinag
Zhuigusan
Da ye qingshener
Mufangji
Hanfangji
Tuteng
Zhuigufeng
Maofangji
Stephania spp.
Stephania
Stephnia tetrandra S.Moore
Fen fsng ji, fang ji
Fang ji (root)
Hang fang ji
Kanboi (Japanese)
Hanbanggi (Korean)
Fun-boui (Japanese)
Sen-mokkou
Vladimiria souliei (franch) Ling
Version 1.0
st
Dated 1 Dec 2011
18
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
Annex 2
Wildlife whose use is prohibited in traditional medicines.
Traditional products are prohibited from containing ingredient derived from the body /
parts of wildlife as listed in the Wildlife Protection Act 1972. Some examples of the
animals and birds whose use is prohibited have been listed as examples below. For full
list of the prohibited wildlife, please refer to the Wildlife Protection Act 1972.
FIRST SCHEDUL COMPLETELY PROTECTED WILDLIFE SPECIES
No
1
English Name
Javan Rhinoceros
Scientific Name
Rhinoceros sondaicus
Malay Name
Badak Raya
2.
Sumatran Rhinoceros
Didermocerus
sumatrensis
3.
Tapir
4.
Banteng
Bos banteng
Banteng, Sapi, hutan
5.
Siamang
Hylobates syndactylus
Siamang
6.
Agile Gibbon
Hylobates agilis
Wak-wak
7.
White-handed Gibbon
Hylobates lar
Ungka
8.
Scaly anteater or
Pangolin
Manis javanica
Tenggiling
9.
Malayan wild Dog
Cuon alpines
Serigala, Anjing hutan
10.
Clouded Leopard
Neofelis nebulosa
Harimau dahan
11.
Marbled Cat
Felis marmorata
Kucing dahan
12.
Flat-headed Cat
Felis planiceps
Kucing hutan
13.
Golden Cat
Felis temminckii
Kucing tulip
14.
Linsang
Prionodon linsang
Linsang
15.
Binturong or Bear-cat
Artictis binturong
Binturong
16.
Slow Loris
Nyticebus caucang
Kongkang, kera duku
17.
Otter civet
Cynogale bennettii
Musang memerang
18.
Derby‟s Banded Civet
Badak Kerbau
Badak Chipan, Badak
Tampong
Tapirus Indicus
Hemigalus derbyanus
Musang belang
19
BiotechCorp
19.
Version 1.0
st
Dated 1 Dec 2011
Martes flavigula
Mengkira
20.
Yellow-throated
Marten
Weasel
Mustela nudipes
Pulasna
21.
Long-tailed porcupine
Trichys lipura
Landak padi
22.
Serow
Capricornis sumatrensis
Kambing gurun,
23.
Selangor Pigmy Flying
Squirrel
Petaurillus kinlochii
Tupai terbang terkecil
24.
Red-cheeked Flying
Squirrel
Hylopetes spadiceus
Tupai terbang pipi merah
25.
Grev-cheeked Dlying
Hylopetes Lepidus
Tupai terbang squirrel pipi
kelabu
26.
Whiskered Flying
squirrel
Petinomys genebarbis
Tupai terbang
berjambang
27.
White-Bellied Flying
Petinomys setosus
28.
Vordemann‟s Flying
Petinomys vordermanni
29.
Horsfield‟s Flying
Squirrel
Lomys horsfieldii
30.
Smoky Flying squirrel
31.
Large Black Flying
Squirrel
Pteromyscus
pulverulentus
Aeromys tephromelas
Tupai terbang hitam
32.
Red Giant Flying
Squirrel
Petaurista Petautista
Tupai terbang merah
33.
Spotted Giant Flying
Petaurista elegant
Tupai terbang squirrel
bintang
34.
Malayan Flying Lemur
Cynocephalus
Kubong
dada putih
kecil
Tupai terbang ekor merah
Tupai terbang kotor
20
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
SECOND SCHEDULE PROTECT WILDLIFE SPESIES
Part I : Binatang-binatang Perburuan besar (Large hunted animals)
No
English Name
Scientific Name
Malay Name
1.
Elephant
Elephas maximus
Gajah
2.
Gaur
Bos gaurus hubbacki
Seladang
Part II : Binatang-binatang perburuan ( Prey animals)
1.
2.
3.
4.
5.
6.
Sambur Deer
Barking Deer
Large Muose-Deer
Lesser Muose-Deer
Tiger
Leopard
7.
8.
9.
Malayan Honey-Bear
Wild pig
Bearded pig
Cervus unicolor equines
Munctiacus muntjak
Tragulus napu
Tragulus javanicus
Pantheratigris
Panthera pardus
Helarctos malayanus
Sus scrofa
Sus barbatus
Rusa
Kijang
Napoh
Pelandok
Harimau belang
Harimau bintang,
Harimau kumbang
Beruang
Babi hutan
Babi bodoh
Part III : Binatang-binatang liar lain yang diperlindungi (Other protected wildlife)
1.
2.
3.
4.
5.
Hairy-nosed Otter
Smooth Otter
Common Otter
Small-clawed Otter
Common Palm Civet
6.
7.
8.
Malay Civet
Short-tailed
Mongoose
Small Indian
Mongoose
Indian Grey
Mongoose
Leopard Cat
Pig-tailed Macaque
Malayan Porcupine
Malayan Flying Fox
Crocodile
Python
Water monitor
Clouded monitor
Dumeril‟s Monitor
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Lutra sumatrana
Lutra perspillata
Lutra lutra
Amblonyx cinerea
Paradoxurus
hermaphrodites
Viverra tangalunga
Herpestes branchyurus
Herpeteses
auropunctatus
Herpestes edwardsii
Felis bengalensis
Macaca nemesrina
Hystrix brachyuran
Pteropus vampyrus
Crocodylus porosus
Python reticulates
Varanus salvator
Veranus nebulosus
Varanus dumeril
Memerang hidung
Memerang licin
Memerang utara
Memerang kecil
Musang pulut
Musang tenggalong
Bambun ekor pendek
Cheperlai,bambun kecil
Bambun kelabu
Kucing Batu
Berok
Landak raya
Kluang
Buaya Tembaga
Ular Sawa
Biawak air
Biawak tikus
Biawak kudong
21
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
THIRD SCHEDULE COMPLETELY PROTECTED WILD BIRDS
No
Name
Family
English Name
Scientific Name
Malay
Name
1.
2.
Grebes
Petrels
Podicipididae
Hydrobatidae
3.
Tropic Birds
Phaethontidae
-Little Grebe
-Wilson‟s
Storm Petrel
-Short-tailed
Tropic Bird
-Podiceps ruficollis
-Oceanitis
Occeanicus
-Phaeton aethereus
4.
Pelicans
Pelecanidae
-White Pelcian
-Pelecanus
onocrotalus
-Undan
Putih
5.
Grannets &
boobies
Sulidae
-Brown booby
-Sula leocogaster
-Dendang
laut
6.
Cormorants
Phalacrocoracidae
-Common
Cormorant
-Phalcrocorax carbo
-Dendang
air
7.
Darters
Anhingidae
-Darter
-Anhinga anhinga
8.
Frigate Birds
Fregatidae
-Christmas
Island Frigatebird
-Fregata andrewsi
-Burung
kosa
-Burung
Simbang
Pulau
9.
Herons
Ardeidae
-Dusky-grey
Heron
-Cattle Egret
-Ardae sumantrana
10.
Stork
Ciconiidae
11.
Ibises
Threskiornithidae
-Burung
Lembu
-Bubulcus ibis
-Burung
Bangau
-Chinese Egret -Egreetta eulophotes Burung
Bangau
China
-Night Heron
-Nycticorax
-Burung
nycticorax
kuak
-Cinnamon
-Ixobrychus
Bittern
eurhythmus
-Puchong
Bendang
-Milky Stork
-Ibis lcinereus
-Burung
-Storm‟s Stork -Ciconia stormi
Upeh
-Lesser
-Leptoptilos
Adjuntant Stork javanicus
-Burung
Botak
-White Ibis
-Threskiornis
-Burung
aethiopica
Sekendi
22
BiotechCorp
12.
Hawks and
Eagles
Accipitridae
Version 1.0
st
Dated 1 Dec 2011
-Bat Hawk
-Machaerhamphus
alcinus
-Crested
-Pernis
Honey Buzzard ptilorhynchus
-Black Eagle
-Ictinaetus
malayensis
-King Vulture
-Torgos calvus
-Long-billed
Vulture
-Gyps indicus
-White-backed
Vulture
-Pseudogyps
bengalensis
-Marsh Harrier
-Circus aeruginosus
-Short-toed
Eagle
-Circaetus gallicus
-Lang
Malam
-Lang
Lebah
-Lang
Hitam
-Burung
Hereng
-Burung
Hereng
Paroh
Panjang
-Burung
Hereng
Belakang
Putih
-Lang
Kepala
Putih
-Lang Jari
Pendek
13.
Osprey
Pandionidae
-Osprey
-Pandion haliaetus
-Lang
Tiram
14.
Falcons
Falconidae
-Red-breasted
Falconet
-Peregrine
Falcon
-Kestrel
-Long-billed
Partridge
-Black Wood
Partridge
-Roulroul
-Chestnutbreasted
Partridge
-Malay
Peacock
Pheasant
-Rothschild‟s
-Microhierex
caerulescens
-Falco peregrines
-Lang
Rajawali
15.
Pheasants,
partidges
Phansianidae
-Great Argus
-Green
Peafowl
16.
Cranes
Gruidae
-Eastern Sarus
Crane
-Falco tinnunculus
-Rhizothera
longirostris
-Melanoperdix nigra
-Rollulus roulroul
-Arborophilia
charlaeni
-Polyplectron
Malacensis
-Rheinartia Ocellata
-Agusianus argus
-Pavo muticus
-Grus antigone
-Burung
Selanting
-Burung
Bertam
-Burung
Siul
-Sang
Serok
-Merak
Pongsu
-Kuang
Raya
Gunung
-Kuang
Raya
-Merak
-Burung
Keria
23
BiotechCorp
17.
Rails, Crakes
& gallinules
Rallidae
-Purple Coot
-Masket
Finfoot
18.
Jacanas
Jacanidae
19.
Gulls & terns
Laridae
20.
21.
Pigeons &
Doves
Cukcoos
Columbidae
Cuculidae
Version 1.0
st
Dated 1 Dec 2011
-Porphyrio
Porphyria
-Heliopais personata
-Panglin
-Burung
Pedendeng
-Pheasanttailed Jacana
-Bronzeweiged Jacana
-White-winged
Black Tern
-Common Tern
-Roseate Tern
-Hydrophasianus
Chirurgus
-Metopidius indicus
-Burung
Teratai
-Chlidonias
leucoptera
-Sterna hirundo
-Sterna doughalli
-Little Tern
-Crested Tern
-Sterna albifrons
-Sterna bergii
-Common
Noddy
-Anous stolidus
-Chamar
Sayap
Putih
-Chamar
-Chamar
Jambu
-Chamar
Kecil
Chamar
Berjambul
-Chamar
Hitam
-Nicobar
pigeon
-Pied Imperial
Pigeon
-Mountain
Imperial
Pigeon
-Coloenas
nicobarica
-Ducula bicolour
-Merpati
Mas
-Rawa
-Ducula badia
-Pergam
Bukit
-Red Turtle
Dove
-Lesser Hawk
Cuckoo
-Hawk Cuckoo
-Banded Bay
Cukcoo
-Koel
-Lesser
Green-billed
Malcoha
-Large Greenbilled Malcoha
-Raffles‟s
Malcoha
-Streptopelia
tranquebarica
-Cuculus vagans
-Cuculus fugax
-Cacomantis
sonnerati
-Eudvnamis
scolopacea
-Phaenicophaeus
diardi
-Phaenicophaeus
tristis
-Phaenicophaeus
chlorophaeus
-Sewah
tekukor
-Sewah
tekukor
Besar
-Burung
Takuweh
-Burung
Tahu
-Burung
Chenok
-Burung
Kera
-Burung
Krak
24
BiotechCorp
22.
23.
Typical owls
Barn Owls
Strigidae
Tytonidae
Version 1.0
st
Dated 1 Dec 2011
-Collared
Scops Owl
-Scops Owl
-Otus bakkamoena
-Reddish
Scops Owl
-Malay Eagle
Owl
-Fish Owl
-Pygmy Owlet
-Otus rufescens
-Spotted Wood
Owl
-Strix seluputo
-Otus scops
-Bubo sumatranus
-Bubo ketupu
-Glaucidium brodiei
-Barn Owl
-Bay Owl
24.
Frogmounths
Podargidae
-Large
Frogmouth
-Blyth‟s
Frogmouth
-Batracostomus
auritus
-Batrachostomus
affinis
25.
Nightjars
Carprimulgidae
26.
Swifts
Apodidae
-Eurostopodus
temmincki
-Caprimulgus
macrurus
-Caprimulgus
indicus
-Collocalia gigas
-Collocalia fuciphaga
27.
Tree Swift
Hemiprocnidae
-Malaysian
Eared Nightjar
-Long-tailed
Nightjar
-Migratory
Nightjar
-Giant Swiftlet
-Grey-rumped
Swiftlet
-White-bellied
Swiftlet
-Malaysian
Spinetail Swift
-Migrant Swift
-Crested Tree
Swift
28.
Trogons
Trogonidae
-Burung
Jampok
-Burung
Hantu
-Burung
Punggok
Kechil
-Burung
Charekkafan
-Burung
Punggok
Api
-Burung
Segan
-Burung
Taptibau
-Burung
Kuber
-
-Layanglayang Gua
-Collocalia esculenta -Layang
padi
-Chaetura gigantean -Layanglayang
-Apus pacificus
besar
-Hemiprocne
-Layanglongipennis
layang
Berjambol
-Hemiprocne comate
-Whitewhiskered Tree
Swift
-Red-naped
-Harpactes kasumba
Trogan
-Diard‟s
-Harpactes Trogon
Tragon
-Orange-Harpacted oreskios
breasted
Trogon
-Burung
Kesumba
-Burung
Gembala
Rimau
25
BiotechCorp
29.
Kingfishers
Alcedinidae
-Common
Kingfisher
-Blue-banded
Kingfisher
-Brown-winged
Stork-billed
Kingfisher
-White-collared
Kingfisher
30.
Bee-eaters
Meropidae
-Bay-haeaded
Bee-eater
-Blue-throated
Bee-eater
31.
Rollers
Crocidae
-Burmese
Roller
31.
32.
Hoopoe
Hornbills
Upupide
Bucerotidae
-Broad-billed
Roller
-Hoopoe
-White-crested
Hornbill
-Bushy-crested
Hornbill
-Blyth‟s
Hornbills
-Pied Hornbills
Version 1.0
st
Dated 1 Dec 2011
-Alcedo atthis
-Alcedo auryzona
-pelargopsis
amauroptera
-Pekaka
Chitchit
-Pakaka
Bukit
-Burung
Buaya
-Halcyon concreata
-Raja
Udang
-Merops leschenaulti -Berekberek
-Merops viridis
-Rengkok
Biru
-Coracias
benghalensis
-Eyrystomus
-Tiong Batu
orientalis
33.
Barbets
Capitonidae
-fire-tufted
Barbet
-Manycoloured
Barbet
-Little Barbet
-Brown Barbet
-Upupa epops
-Berenicornis
-Enggang
comatus
Bulu
-Anorrhinus galeritus -Enggang
Buluh
-Aceros plicatus
-Burung
-Antharacoceros
Jawa
coronatus
-Burung
-Buceros rinoceros
Tangling
-Enggang
-Buceros bicornis
-Enggang
Papan
-Psilopogonn
-Burung
pyrolophus
Tekukur
-Megalaima rafflesi
Akar
-Burung
-Megalaima australis Takor
-Colorhampus
Tukang
fuliginosus
Besi
34.
Honey-guide
Indicaoridae
-Malay Honeyguide
-indicator
archipelagus
-Rhinoceros
Hornbill
-Great Hornbill
-Musoh
Lebah
26
BiotechCorp
35.
36.
Woodpeckers
Broadbills
Picidae
Eyrylaimidae
-Speckled
Piculet
-Scally-bellied
Woodpecker
-Bamboo
Green
Woodpecker
-Banded Red
Woodpecker
-Olive-backed
Three-toed
Woodpecker
-Great Slaty
Woodpecker
-Marron
Woodpecker
-Pale-headed
Woodpecker
-Green
Broadbill
-Long-tailed
Broadbill
-Balck-and-red
Broadbill
-Dusky
Broadbill
37.
Pittas
Pittidae
Version 1.0
st
Dated 1 Dec 2011
-Picumnus
innominatus
-Picus virdanus
-Pelatok
Belang
-Pelatok
-Picus vittatus
-Pelatok
Hijau
-Picus miniaceus
-Dinipium rafflesi
-Mulleripicus
pulverulentus
-Blythipicus
ribiginosus
-Gecinulus grantia
-Calyptomena viridis
-Psarisomus
dalhousiae
-Cybirhynchus
macrorhynchos
-Corydon sumtranus
-Giant Pitta
-Pitta caerulea
-Garnet Pitta
-Pitta granatina
-Blue-tailed
Pitta
-Pitta guajana
-Pitta sordid
-Hooded Pitta
38.
Swallows
and martins
Hirundinidae
-House Martin
-Barn Swallow
-Pacific
Swallow
-Red-rumped
Swallow
-Delichon urbica
-Hirundo rustica
-Hirundo tahitica
-Hirundo striolata
-Pelatok
Merah
-Pelatok
Rimba
-Pelatok
Gajah
-Pelatok
Punggor
-Pelatok
Buluh
-Burung
Takau
-Burung
Hujanhujan
-Burung
Rakit
-Burung
Pachat
-Burung
Pachat
Kepala
Merah
-Burung
Pachat
ekor Biru
-Burung
Gembala
Pelandok
-Layanglayang Gua
27
BiotechCorp
39.
40.
Minivets and
greybirds
Bulbuls
Campephagidae
Pycnonotidae
Version 1.0
st
Dated 1 Dec 2011
-Hook-billed
Greybird
-Barref
Greybird
-Pied Triller
-Ashy Minivet
Tephrodornis gularis
-Mountain
Minivet
-Scarlet
Minivet
-Pericrocotus solaris
-Black-andwhite Bulbul
-Black-headed
Bulbul
-Black-crested
Yellow Bulbul
-Scalybreasted
Bulbul
-Large Olive
Bulbul
-Scrub Bulbul
-Pycnonotus
melanoleucos
-Pycnonotus
atriceps
-Merbah
Tandok
Burung
Siam
-Pycnonotus dispar
-Crested
Bulbul
-Criniger ochraceus
-Merbah
Kunyit
-Merbah
Bersisik
-Murai
Rimba
-Burung
Rabah
-Merbah
Berjanggut
-Mountain
Streaked
Bulbul
-Hypsipetes
moclellandi
-Hypsipetes flavalus
-Coracina striata
-Lalage nigra
-Percrocotus roseus
-Pericrocotus
flammeus
-Pycnonotus
squamatus
-Pycnonotus
plumosus
-Criniger bres
-Ashy Bulbul
41.
Leafbirds
and Fairy
Irenidae
-Common Lora
-Aeghitina tiphia
-Lesser Green
Leafbird
-Chloropsis
cyanopogon
-Greater Green -Chloropsis
Leafbird
sonnerati
-Fairy Bluebird -Irena puella
42.
Drongos
Dicruridae
-Crow-billed
Drongo
-Bronzed
Drongo
-Lesser
Racket-tailed
Drongo
-Large Rackettailed Drongo
-Merbah
Rimba
-Punai
Rimba
-Kuang Kuit
-Burung
Chok
Padang
-Burung
Mata Hari
-Dicrurus annectans
-Burung
Barau Bukit
-Burung
Tuar
-Kelichap
Kunyit
-Burung
Daun
Besar
-Burung
Daun Kecil
-Murai
Gajah
-Chechawi
-Dicrurus aeneus
-Burung
Paha Kelati
-Dicrurus remifer
-Burung
Chawi
-Dicrurus paradiseus Chawi
BurungCha
Hamba
Kera
28
BiotechCorp
43.
Orioles
Oriolidae
44.
Crows and
jays
Corvidae
45.
Titmice
Paridae
46.
Nuthatches
Sittidae
47.
Flycatchers
Muscicapidae
48.
Bablers
Timaliidae
Version 1.0
st
Dated 1 Dec 2011
-Black-naped
Oriole
-Malaysian
Black-headed
Oriole
-Oriolus chinensis
-Burung
Kunyet
-Oriolus xanthonotus Besar
-Burung
Kunyet
Kecil
-Crested Malay -Platylophus
-Burung
Jay
galericulatus
Menjerit
-Green Magpie -Kitta chinensis
-Burung
Gagak
Gunung
-Black-Crested -Platysmurus
-Burung
Magpie
leucopterus
Kambing
-Sultan Tit
-Melanochlora
-Serai-serai
sultanea
-Velvet-fronted -Sitta frontalis
Nuthatch
-Blue Nuthatch -Sitta azurea
-Whtie-Rhipidura albicollis
-Merbah
throated
Gila
Fantail
Gunung
Flycatcher
-Pied fantail
-Rhipidura javanica
Flycatcher
-Niltava
-Muscicapa grandis
-Merbah
Gila
-Siberian
-Muscicapa sibirica
-Burung
Flycatcher
Kubung
Padi
-Pale Blue
-Muscicapa unicolor Flycatcher
-Malaysian
-Muscicapa turcosa
Blue
Flycatcher
-Tickell‟s Blue
-Muscicapa Ticellae -Kelicap
Flycatcher
Ranting
-Hill Blue
-Muscicapa
Flycatcher
banyumas
-Narcissus
-Muscicapa
Flycatcher
narcissina
-Maroon- Philentoma vilata
-Merbah
breasted
Batu
Flycatcher
-Murai
-Paradise
-Terpsiphone
Ekor
Flycatcher
paradise
Gading
-Japanese
-Terpsiphone
-Murai
Paradise
atrpcaudata
Flycatcher
-Murai
-Magrove
-Pachycephala
Bakau
Whistler
cinerea
-Rail babler
-Eupetes
macrocerus
-Burung
Gemabala
Kera
29
BiotechCorp
-Striped Babler
-Blyth‟s Jungle
Babbler
-Abott‟s Jungle
Babbler
-Graeter Redheaded tree
Babbler
-Lesser-Redheaded Tree
Babbler
-Plain Bubbler
-Striped Wren
Babbler
-Small Wren
Babbler
-Pygmy Wren
Babbler
-Striped Tit
Babbler
Version 1.0
st
Dated 1 Dec 2011
-Pellorneum ruficeps
-Trichastoma
rostratum
-Trichastoma abbotti
-Malacopteron
magnum
-Malacopteron
cinereum
-Malacoperon affine
-Kenopia striata
-Napothera
brevicaudata
-Pneopyga Pusilla
-Macronus Gularis
-Fluffy-backed
Tit Babbler
-White-eared
Tree Babbler
-Macronus ptilosus
-Golden Tree
Babbler
-Silver-eared
Mesia
-Cutia
-Common Nun
Babbler
-White-beilled
Crested
Babbler
-White-headed
Babbler
-Long-tailed
Sibia
-Stachyris chrysea
-Stachyris leucotis
-Leiothrix
argentauris
-Cutia nepalensis
-Alcippe poiocephala
-Yuhina zantholeuca
-
-Burung
Terlanjor
-Murai
Belukar
-Murai
Rimba
-Burung
Tua Pulih
-Burung
Resam
-Merbah
Sampah
Kuning
-Burung
Pong-pong
-Kelicap
Bunga
Kantan
-Kelicap
Mas
-Murai
Sampah
-kelicap
Berjambul
-Gamsorhynchus
rufulus
-Heterophasia
picaoides
30
BiotechCorp
49.
Warblers
Sylviidae
50.
Thrushes
Turdidae
51.
Wagtails and
pipits
Motacilidae
-Fly-eater
-Gerygone fusca
-Streaked
Fantail Warbler
-Green Leaf
Warbler
-Arctic Leaf
Wabler
-Streaked
Grasshopper
Warbler
-Whitethroated
Flycatcher
Warbler
-Black-necked
Tailor Bird
-Siberian Blue
Robin
-Common
Shama
-Chestnutnaped Forktail
-Slaty-backed
Forktail
-Blue-Rock
Thrush
-Grey-headed
Thrush
-Blue Whistling
Thrush
-Stone Chat
-Siberian
Ground Thrush
-Grey Wagtail
-Cristicola juncidis
-Richard‟s Pipit
52.
Shrikes
Laniidae
Version 1.0
st
Dated 1 Dec 2011
-Phylloscopus
trivirgatus
-Phylloscopus
occipitalis
-Locustella
lanceolata
-Seicercus
superciliaris
-Prthotomus
atrogularis
-Kelicap
Perepat
-Burung
Laki Padi
-Burung
Tikus
-Kelicap
Buluh
-Kelicap
Pucat
Pisang
-Luscinia cyane
-Murai
Batu
-Copsychus
-Burung
malabaricus
Chegar
-Enicurus ruficapillus -Burung
Chegar
-Enicurus
Besar
schistaceus
-Burung
-Monticola Solitaria
Tarom
-Murai
-Turdus obscures
Belanda
-Tiong
-Myiophoneus
Belacan
coeruleus
-Saxicola torquata
-Zoothera sibirica
-Motacilla cinerea
-Anthus
novaeseelandie
-Forest Wagtail -Motacilla indica
-Yellow
-Motacilla flava
Wagtail
-Schach Shrike -Lanius schach
-Brown Shrike -Lanius shrike
-Thick-billed
-Lanius tigrinus
Shrike
-Mentua
Pelandok
-Burung
Apit-apit
-Burung
Tirjup
31
BiotechCorp
53.
54.
Flowerpeckers
Sunbirds and
spiderhunters
Dicaeidae
Nectariniidae
55.
White-eye
Zosteropidae
56.
Starling
Sturnidae
57.
Sparrows
and finches
Ploceidae
Version 1.0
st
Dated 1 Dec 2011
-Scarletbacked
Flowerpecker
-Javan Firebreasted
Flowerpecker
-Plain
Flowerpecker
-Yellowthroated
Flowerpecker
-Hume‟s
Flowerpecker
-Brownthroated
Sunbird
-Dicaeum
cruentatum
-Dicaeum
sanguinolentum
-Burung
Sepah Putri
-Burung
Sepah Putri
Gunung
-Anthreptes
malacensis
-Kelicap
Mayang
Kelapa
-Ruby-cheeked
Sunbird
-Purple-naped
Sunbird
-Van Hasselt‟s
Sunbird
-Yellow-backed
Sunbird
-Scarlet
Sunbird
-Anthreptes
singalensis
-Nectarinia
hypogrammica
-Nectarinia sperata
-Kelicap
Belukar
-Kelicap
Rimba
-Little
Spiderhunter
-Lesser
Yellow-eared
Spiderhunter
-Streaked
Spiderhunter
-Oriental
White-eyed
-Daurian
Starling
-Chinese
Starling
-Gold-crested
Myna
-Chinese
Crested Myna
-Pin-tailed
Parrot Finch
-Bamboo
Parrot Finch
-Brown
Bulfinch
-Yellowbreasted
Bunting
-Arachnothera
longirostris
-Arachnothera
chrysogenys
-Kelicap
Jantong
-Kelicap
Pisang
-Arachnothera
magna
-Zosteropidae
palpebrosa
-Sturnus sturninus
-Kelicap
Kunyit
-Dicaeum concolor
-Prionochilus
maculates
-Dicaeum modestum
-Aethopyga siparaja
-Aethopyma
mystacalis
-Sturnus sinensis
-Ampeliceps
coronatus
-Aridotheres
cristatellus
-Erythrura prasina
-Erythrura hyperthra
-Pyrrhula nipalensis
-Emberiza aureola
-Chiak
Perut
Merah
-Pipit
Gunung
32
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
Annex 4
Claims Acceptable for Traditional Product
No
Categories
1
General Health
Maintenance
Indication Claims
Traditionally used or homeopathically used..

















for general health maintenance
for general health
for health and strengthening the body
for relief of body heatiness
for general debility, weakness after illness of childbirth
for loss of appetite
for difficulty in sleep
for relief of fatigue
as an aid to overcome fatigue during physical exertion
to expel wind and invigorate vital energy
to improve appetite
for relieving waist ache and body weakness
for relieving dizziness, sweating and difficulty in sleep
for reducing body odour
for reducing toothache
to relieve tired eyes
for healthy eyes
2
Blood & Body
Fluid





Traditionally used for improving blood circulation
Traditionally used to improve urination
Traditionally used for improving bowel movement
Traditionally used for relieving mild vomiting
Traditionally used for reducing minor swelling
3
Bone, Muscle &
Joint





Traditionally used for strengthening muscle & bone
Traditionally used for relieving muscular ache
Traditionally used for relieving waist ache and backache
Traditionally used for relief of joints and muscular pain
Traditionally used for relieving muscles sprain
4
Pain & Fever




Traditionally used to relieve / alleviate pain
Traditionally used for relieving fever
Traditionally used for relieving headache
Traditionally used for relieving pain and itchiness related to
piles
 Traditionally used for symptomatic of body heatiness or
body heat
34
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
 Traditionally used for relief of fever, cough and cold
 Traditionally used for relief of sore throat
 Traditionally used for reducing phlegm and relief cough,
sore throat and body heatiness
 Traditionally used for relief of throat irritations and cough
 Traditionally used for relief nasal congestion
 Traditionally used for relief of sore throat and cough
 Traditionally used for relief of mouth ulcers due to
heartiness
 Traditionally used to relieve sinusitis
5
Cough & Cold
6
Digestive System  Traditionally used for relief stomach ache, mild diarrhoea
 Traditionally used for relief of flatulence, stomach ache,
mild diarrhoea and loss of appetite
 Traditionally used for relief mild diarrhoea, vomiting and
improve appetite
 Traditionally used for relief mild constipation
 Traditionally used to improve appetite and digestion
 Traditionally used for relieving abdominal pain and
flatulence
 Traditionally used for relief of stomach ache, constipation,
mild vomiting and indigestion
 Traditionally used for aid in digestion
7
Women‟s Health
 Traditionally used to relief menstrual pain, headache and
regulate menstruation
 Traditionally used to reduce body weight
 Traditionally used for relief of vaginal discharge
 Traditionally used for women after childbirth
 Traditionally used for general wellbeing and strengthen the
body after childbirth
 Traditionally used for women after childbirth to reduce body
weight
 Traditionally used for symptomatic relief of vaginal
discharge and mild itch
 Traditionally used to improve menstrual flow, for relief of
menstrual pain, vaginal discharge and flatulence
 Traditionally used for strengthening body muscle and
reducing body weight
 Traditionally used for general health of women after
childbirth
 Traditionally used to relief symptoms of menopause
(for specific ingredients only examples: Red clover
( Trifolium Pratense) and Black cohosh ( Cirmicifuga
racemosa )
8
Men‟s Health
 Traditionally used for energy and men‟s health / for vitality
35
BiotechCorp
9
Version 1.0
st
Dated 1 Dec 2011
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
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
Annex 5
Functional Claims acceptable for Health Supplement
No
1
Item
Vitamin A
2
Vitamin C
3
Vitamin D
4
Vitamin E
5
Thiamine
(Vitamin B1)
6
Beta Carotene
7
Riboflavin
(Vitamin B2)
8
Niacin
(Vitamin B3)
9
Pyridoxine
(Vitamin B6)
10
Cyanocobalamine
(Vitamin B12)
Claims
 Maintenance of good health
 Helps to maintain growth, vision and tissue
development
 Aids in maintaining the health of the skin and
mucosa membrane
 For health bones, teeth, gums as well as general
make-up of the body
 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
 Helps to maintain good health
 Helps normal growth
 Helps the body to metabolize carbohydrates
 Helps in maintenance of growth, vision and tissue
differentiation
 A factor in maintenance of good health
 Helps the body to utilize energy from
food/metabolize proteins, fats and carbohydrate
 Claim for specific population subgroups:
- Additional amounts of Riboflavin are required
during pregnancy and breast feeding when
diet does not provide a sufficient daily intake





A factor in maintenance of good health
Helps normal growth and development
Helps the body in utilization of energy from food
A factor in maintenance of good health
Helps the body to metabolize proteins, fats and
carbohydrates
 Helps in maintenance of good health
 Helps in formation of red blood cell
37
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
11
Folic Acid
 Helps in the formation of red blood cell
 Helps prevent neural tube defects for women who
are planning a pregnancy before conception and
during 12 weeks of pregnancy at a dose of
400mcg daily
12
Biotin
 Helps to metabolize fats and carbohydrates
13
Pantothenic Acid
 Helps in maintaining of good health
 Helps to metabolized fats and carbohydrates
14
Calcium
15
Phosphorus
16
Magnesium
 Helps in maintaining in good health
 Helps in the formation and maintenance of bones
and teeth
 Claim for specific population subgroups;
-Additional calcium is required for pregnant and
lactating women, when diet does not provide a
daily sufficient intake to help in proper bone
formation in developing baby
 Helps in the formation and maintenance of bones
and teeth
 Helps the body to metabolize carbohydrate
17
Iron
18
Iodine
19
Zinc
20
Copper
21
Manganese
 Helps the body to metabolize carbohydrates and
protein
22
Probiotics
 Helps improve a beneficial intestinal microflora






Helps in maintenance of good health
Helps in formation of red blood cell
Helps to prevent iron anaemia
Helps to prevent anaemia due to iron deficiency
Helps in maintenance of good health
Helps in the function of the thyroid glands
 Helps to metabolize carbohydrates, fats and
protein
 Helps in formation of red blood cell
38
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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.
43
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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.
44
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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.
45
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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)
46
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
3. Copy of your company‟s letter authorisation;
4. Copy of Company Registration Form
5. Payment in money order or postal order.
To:
Digicert Sdn Bhd (457608-K),
No. 3-20 & 3-22, Jalan Jalil Perkasa14,
Aked Esplaned, Bukit Jalil,
57000 Kuala Lumpur.
Tel: 03-89928888
Payment for the Smart Card System must be made to Digicert Sdn Bhd.
You can make the payment by using either money order or postal order after you submit
the application of Quest 3 via online. The USB token will be sent to you by POS LAJU
within 7 working days upon receipt of payment to the company address specified in the
form.
Your password to logon to the system will be emailed to you at the email address specified
in the form upon registration approval by BPFK.
To begin your product registration application, go to the www.bpfk.gov.my/ webpage, and
click on the Quest3 System main page. Enter your correct login name and password. You
may start submitting your application online from there on.
47
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
(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
48
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
To access to the Quest3 system please click at “registered user? Please click here”
Figure 9: National Pharmaceutical Control Bureau Quest3 Webpage
49
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
Key in the smart card pin number, and verify your identity by clicking at “verify my identity”
Figure 10: Verified your identity
50
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
After you have verified your identity, the system required you to login the system.
You may log in with your previous username and new password. The new password is
Quest3. As the first time user with Quest 3 system, you are required to change your
password and reconfirm the password.
After you change the password, the system will automatically log in into Quest 3
Account.
51
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
Once you have successfully logged in, choose new registration form for traditional or
pharmaceutical product and you can start submitting your applications online from there on.
In the registration section, you may submit the new application for new product such as
NCE, Biotechnology, Poison, OTC, Health Supplement and Traditional.
In Cosmetic section, you may submit the new application for new cosmetic notification.
In Lab section, you may submit of the registration sample for traditional product only.
Validity
The validity of the smart card is 2 years. Within 30 days before the expiry date, the
system will notify you through your email address for renewal of your smart card.
For more information regarding the Smart Card system, please contact Digicert Sdn Bhd
at 03-89943066 or email at customercare@digicert.com.my
52
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
Annex 8
Example of Import Permit
53
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
Example of application letter for import permit
54
BiotechCorp
Version 1.0
st
Dated 1 Dec 2011
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
55

Registration of Traditional and Health Supplement

Transcription

Similar documents

guidelines on registration of traditional and health

Menu EN 2016

sweet sweet - Slimming World

SAMENTO SAMENTO

REAL-TIME REAL-TIME

KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES

Wednesday, Dec. 12, 11 am to 1 pm Texins Activity Center

DAY OF SYN - Romney Marsh

Form B. Hybrd, Online, or Supplement