__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1NATIONAL PHARMACEUTICAL CONTROL BUREAU  
MINISTRY OF HEALTH MALAYSIA  
PETALING JAYA  
 
 
 
 
  DRUG REGISTRATION GUIDANCE DOCUMENT  
  
 
 
 
PREAMBLE  
 
This “ DRUG REGISTRATION GUIDANCE DOCUMENT” will serve as the 
reference guide for both pharmaceutical products for human use and traditional 
products. It will replace the “ Guidelines for Application for Registration of 
Pharmaceutical  Products ” Third Edition of October 1993  and “ Garispanduan 
Permohonan  Pendaftaran Keluaran Ubat Tradisional ” Second Edition, 
December 1998.  The contents of this version include:  
 Updated information relating to administrative requirements and 
procedures.  
 Information on Drug Control Authority (DCA) policies currently applicable.  
 Guidelines on the on -line application process and requirements which  will 
incorporate the ASEAN technical requirements and standards for 
pharmaceuticals (where applicable).  
An on -going review of policy matters will continue, taking into account the global  
regulatory environment, to allow for timely and pertinent changes.  
Information relating to DCA policy de cisions is current up to its 220th meeting on 
01 Oktober 2009 . Please visit the National Pharmaceutical Control Bureau 
(NPCB) website at http://www.bpf k.gov.my for updates in regulatory information.  
 
 
 
March 2010  Revi sion  
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 2List of amendments / changes:  
 
March 2010 Revision  
 
6. REGULATORY OUTCOME  
 -    Addition of sub -point 6.7 Reapplication of Rejected Products  
 
 
Section D: Label (Mockup) For Immediate Container, Outer Carton and 
Proposed Package Insert  
- Addition of phrase  ‘Product that contains Nevirapine: Addition of phrase 
“Retriction of Nevirapine use in patient with CD4+cell count greater than 
250cells/mm3 on the product label.Product Holder is fully responsible to 
inform prescriber pertaining to the restriction in use of Nevirapine.  
 
Updated on 30 March 2010 from DCA Policy 3/2009  
13.8 Guide for Implementation of Patient Dispensing Pack for 
Pharmaceutical Prod ucts in Malaysia.  
13.9.5  Criteria for implementation of patient dispensing packs.  
-Addition of phrase ‘Oral chemotherapies must be packed in blister 
packing to minimize the contact which can avoid the toxic effect of 
chemotherapy.  
Updated on 30 March 2010 from DCA Policy 3/2009  
 
 
Appendix 12: Guidance notes for Traditional Products  
- Addition of data that need to be submitted  for product registration  
 
Updated on 30 March 2010 from DCA Policy 3/2009  
 
 
Disember 2009 Revision  
 
Appendix 4: Types of variations and supporting documentation required.  
- Addition of Title of Variation ‘ Change in Product Owner’  and its 
Supporting Documents Required/ Conditions to Be Fulfilled  
 
Appendix 7 :  
- Addition of phrase under 3. PRESERVATIVES   
 
4.4 Multiple Applications  
-    Addition of phrase  under 4.4.2: ‘For biological/Biotechnological products, 
a third source  may be considered, where deemed necessary’  
 
12. CHANGE IN MANUFACTURING SITE   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 3-     Addition of phrase under 12.1 : ‘ Note: Change of manufacturing site for   
biological/biotechnological products are not allowed. New registration 
application must be submitted.  
 
 
Oktober 2009 Revision  
 
Appendix 1.1 : Product Identification Chart  
 
- Amendment on Product Identification Chart  
 
Appendix 3: SPECIFIC LABELLING REQUIREMENTS (LABEL & PACKAGE 
INSERT ) 
- Addition of Colchicine, COX -2 Inhibitors, and Immunosuppresants 
in the List of Specific Labelling Requirements (Label & Package Insert ) 
 
Section  D: Label (Mockup) For Immediate Container, Outer Carton and 
Proposed Package Insert  
 
- Amended item No. 21 and 22.  
 
 Parameters  Unit 
Carton  Inner 
Labels  Blister/Strips  
21. The words “Controlled Medicine/ Ubat 
Terkawal” (for scheduled poison only)   * NA 
22. Security Label   * NA 
 
- Deletion of phrase ‘ where inner label is too small, this statement may be 
printed on the outer label’  
 
 
September 2009 Revision  
 
Appendix 3: SPECIFIC LABELLING REQUIREMENTS (LABEL & PACKAGE 
INSERT ) 
- Addition of phrase “ WHEN USED FOR TREATMENT OF COUGH 
AND COLD” on the label and package insert for oral liquid product 
containing  
(i) Brompheniramine   (vii) Ephedrine  
(ii) Chlorpheniramine   (viii) Pheniramine  
(iii) Clemastine    (ix) Phenylephrine  
(iv) Dexbrompheniramine   (x) Promethazi ne 
(v) Dextromethorphan   (xi) Pseudiephedrine  
(vi) Diphenhydramine   (xii) Triprolidine  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 4Appendix   6 :  
 
Addition of BACILLUS COAGULANS , ENTEROCOCCUS FAECALIS  and 
ENTEROCOCCUS FAECIUM  in the List of ingredients (active) not allowed 
to be registered by the Drug Control Authority  
 
  
 
August 2009 Revision  
 
Appendix 3: SPECIFIC LABELLING REQUIREMENTS (LABEL & PACKAGE 
INSERT ) 
- Addition of Anti-epileptics, Clopidogrel, Propylthiouracil in the  
List of Specific Labelling Requirements (Label & Package Insert)  
 
Appendix 2 :  List of a particular product or group of products with special 
conditions for registration  
- Deletion No. 1 -3 of Conditions for Registration under  14. Human 
Growth Hormone  
 
Appendix 9.10 : List of Non Permissible Product Name f or Health Supplement 
Produc ts.  
- Addition of the above l ist in English version  
 
Appendix 12.7 :  Prohibited Visual / Graphics on Label of Natural Products  
- Addition of the above l ist in English version  
 
Appendix 12.8 :  List of Non Permissible Product Name for Natural Products.  
- Addition of the above l ist in English version  
 
 
July 2009 Revision  
 
5.  PROCESSING OF APPLICATIONS  
 
Addition of sub -heading  ‘5.3 Rejection of Application for A New Product ’  
 
10. TERMINATION OF PRODUCT REGISTRATION  
  
 Addtion of  sub-heading 10.2   
10.2 Adulterated Products   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 5Any registered product found to be adulterated, the following action will 
be taken by DCA. ……….  
 
11. CHANGE IN MARKET AUTHORIZATION HOLDER OF A REGISTERED  
PRODUCT  
 
 Addition of phrase as like below :  
 
 Letter of authorization from product owner  
 Certificate of Registration of company/business of the proposed new holder  
 
12. CHANGE IN MANUFACTURING SITE  
 
- Addition of phrase  ‘Application for type V change of manufacturing site 
must be made within three (3) months  from the date of the crisis occurred.  
June 2009 Revision ’ under Type V : Crisis Situation  
 
- Addition of sub -heading 12.4  
12.4 Application for change in manufacturing site will be rejected is 
applicant failed to submit……………………………  
 
13. OTHER INFORMATIONS  
 
 Addition of sub -heading 13.9  
13.9 Guide for Implementation of Patient Dispensing Pack for 
Pharmaceutical Porducts in Malaysia.  
 
SECTION D : LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER 
CARTON AND PROPOSED PACKAGE INSERT  
Addition of phrase ‘ Official website of the company or website for any 
purpose of product promotion from the MAH/product owner/manufacturer is 
not allowed to be printed on the product label (applicable to all catego ries 
of products included imported products). However, email address of the 
company is permissible.  
 
Appendix 2 :  List of a particular product or group of products with special 
conditions for registration  
- Deletion of ‘Conditions for Registration ’ of Amlod ipine  
 
 
Appendix 3: SPECIFIC LABELLING REQUIREMENTS (LABEL & PACKAGE 
INSERT ) 
  
1. Deletion of the whole section of ‘41. EPC PRODUCTS’  
2. Addition of Salbutamol, Terbutaline, Ariprazole, Clozapine, 
Olanzapine, Quetiapine, Risperidone, Zaprasidone, Anti - 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 6depressants , Aspartame  in the List of Specific Labelling Requirements 
(Label & Package Insert)  
3. Addition of phrase ‘Increase risk of birth defects, fetal and neonatal 
morbidity and death when used throughout pregnancy’ under 1. ACE 
INHIBITOR  
 
Appendix 6 :  
Addition of PERGOLIDE & PHENYLPROPANOLAMINE in the List of 
ingredients (active) not allowed to be registered by the Drug Control 
Authority  
 
Appendix 11 : Guidance specific for OTC External Personal Care Products  
 
Deletion of entire section of Appendix 11 as all OTC External Personal Care 
Products are now categorized as Cosmetic Products.  
 
Appendix 12: Guidance notes for Traditional Products  
 
Addition of phrase ‘Effective from 1 December 2007, premixed ingredient(s) 
shall not be used in traditional products formulation.  
 
 
 
June  2009 Revision  
 
Appendix 3  
 
 Insertion of a ddition al information on specific labeling requirement (label & 
package insert)  for oral liquid preparations containing:  
I. Brompheniramine  
II. Chlorpheniramine  
III. Clemastine  
IV. Dexbrompheniramine  
V. Dextromethorphan  
VI. Diphenhydramine  
VII. Ephedrine  
VIII. Pheniramine  
IX. Phenylephrine  
X. Promethazine HCL  
XI. Pseudoephedrine  
XII. Triprolidine  
 
 
Appendix 9  
 
 Addition of “SMART”  in the List of Non Permissible Product Name for 
Health Supplement .  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 7 
 
Appendix 12  
 
Appendix 12.4 
 
 Addition of  Name and address of Marketing Authorization Holder into the 
Labelling Requirements For Traditional Products  
 
 
Appendix 12.8  
 
 Addition of “SMART”  in the List of Non Permissible Product Name For 
Natural Products.  
 
 
 
May 2009 Revision  
 
Appendix 9  
 
9.4   Activ e Ingredients in Health Supplement  
 
 Omission of “pycnogenol” from  List B: List of Active ingresients that are 
allowed to be combined with active ingredients in List A.  
 
 
April 2009 Revision  
 
SECTION 3  
3.1 Application Type  
Additional Notes : 
1. Amended the additional notes to Product containing Glucosamine,  
     Chondr oitin and Methylsulonylmethane (MSM)  and its content.  
 
 
March 2009 Revision  
 
Appendix 5  
 Addition of ‘Report of bioavailability and bioequivalence studies for generic 
products and dissolution profile for innovator products (refer to ASEAN 
Guidelines and list of products requiring BA and BE study) ’ in the list of 
documentation to be supplied under CHANGE OF MANUFACTURING 
SITE WITHIN MALAYSIA.  
 
Appendix 9   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 8 
 Deletion of the whole section ‘Upper daily limits of vitamins and minerals 
for adults allowed in dietary supplements’  
 Addition of a new section ‘Guidance notes for Health Supplements’  
 
Appendix 13  
 
 Incorporat ion of the Appendix 13  (Functional claims  for Health Supplement 
Products) into Appendix 9  
 
 
Section 13.4  
 Addition of the word ‘formulation’ into the seco nd bullet for item 13.4.1 : 
Product(s) which contain ingredients / formulations  not 
allowed…………as supporting data.  
 
 
January 2009 Revision  
 
Appendix 3  
 Addition of the phrase ‘for health supplement products’ into ‘ The 
following warning shall be included on the labels and in the package insert 
of oral p reparations containing Arginine for health supplement product s’  
 
Appendix 6  
 Addition of the word BORAX as an  option for ’ BORIC ACID/ BORAX  …’ 
 
November 2008 Revision  
 
Appendix 6  
 Addition of the phrase ‘excluding traditional products’  into ‘ANIMAL 
ORGAN’  
 
Appendix 12.7  
 Deletion of the phrase ‘EPHEDRINE FREE’ , ‘SUGAR FREE’  and 
‘CAFFEIN FREE’  from ‘Negative Remarks’  
 
August 2008 Revision  
 
Appendix 2  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 9 Addition of Amlodipine in the List of a particul ar product or group of 
products with special  conditions for registration  
 
July 2008 Revision  
 
Appendix 7  
 
 Addition of Chlorofluorocarbons in the List of i ngredients (excipient) banned 
/ allowed  only to specified limits  
 
 
 
Appendix 13  
 
 Addition of Claims allowed for Vitamin A, Vitamin D, Ir on and Probiotics in 
Functional Claims f or Health Supplement Products.  
 
 
June 2008 Revision  
 
SECTION 1  
 
Appendix 12  
 
12.6 
Amended the Quality Control Test specifications for traditional products  
 
SECTION 2  
 
Section D: Label (mockup) for immediate container, outer carton and proposed 
package insert  
 
Outer (carton), Inner & Blister/Strip Labels  
 Reinsertion of the missing labeling requirement number 21.  
 
Package inserts  
 Reinsertion of the missing labeling requi rements numbers 
xvi), xvii) and xviii).  
 
May 2008 Revision  
 
Appendix 12  
 
Deletion of the phrase ‘DILULUS OLEH KEMENTERIAN KESIHATAN /DILULUS 
OLEH KKM’  under subtopic Additional Statement to be Printed .  
 
12.3  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 10Addition of sub -appendix “12.3 SPEC IFIC INGREDIENTS NOT ALLOWED TO 
BE REGISTERED UNDER TRADITIONAL MEDICINE”  
 
Renumbered sub -appendices 12.3 – 12.8 to 12.4 – 12.9 following the addition of 
the sub -appenix  stated above.  
 
12.4 
Under sub -heading LABEL AND PACKAGE INSERT  
 Added the word “amendments” in the statement “For changes and 
amendments,  submit…”  
 Added the statement “…/ini adalah ubat tradisional ATAU This is a 
homeopathy  medicine/ini adalah ubat homeopati”  
 Added the statement “For products containing animal origin(s), please add 
this statement: This product contains substance(s) from animal origin ” 
 
For products containing GINSENG…  
 Added the statement “Safety on long term use has not been established”  
 
For products containing BEE POLLEN…  
 Added the word “anaphylactic” into the state ment “…including fatal 
anaphylactic  reactions…”  
 
For products containing BLACK COHOSH…  
 Added the scientific name “ Cimicifuga racemosa ” 
 
In the table LABLLING REQUIREMENTS  
 Added “to declare source of ingredients derive d from animal origin, 
including gelatine  (active, excipient, and/or capsule shell)”  
 Added under Warning Label:  
e. Chelidonium majus  
f. …( Medicago sativa ) 
h. Black cohosh  
i. Propolis  
j. Royal jelly  
k. Ginkgo biloba /Ginkgo extract  
l. Pelargonium sidoides  
m. Benyl Alcohol/Phenymethanol (pre servatives)  
n. Substances from seafood  
 
12.5 
Under GENERAL HEALTH MAINTENANCE  
 Added the statements “ Digunakan secara homeopati untuk…  / 
”Homeopathicall used… ”  
 Added the statement “16. to relive tired eyes / untuk melegakan kepenatan 
mata.”  
 Added the state ment “17. for healthy eyes / untuk kesihatan mata”   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 11 
Under COUGH & COLD  
 Added the statement “8. to relieve sinusitis/untuk melegakan resdung.”  
 
Under WOMEN’S HEALTH  
 Added the statement “11. to relieve symptoms of menopause/untuk 
melegakan simptom  menopause...”  
 
 
 
12.8 
 Added the statement “12. Tidak dibenarkan menggunakan nama yang 
melambangkan  pengurangkan berat badan/melansingkan badan”, 
”Contoh: - Slim, Langsing, Trim,Trimnfit ” 
 Added the word “IQ” in point number 13.  
 
April 2008 Revision  
 
Appendix  3 
Addition of specific labeling requirement (label & package insert) for Pelargonium 
Sidoides  
 
Appendix 6  
 
Addition of Crinis Carbonisatus as ingredi ents (active) not allowed to be registered 
by the  Drug Control Authority  
 
March 2008 Revision  
 
SECTION 1  
 
4. Application Formalities  
 
In the second paragraph, ‘ The applicant for product registration must be locally  
incorporated company with a permanent address.’ amended to ‘The applicant for 
product  registration must be registered with Suruhanjaya Syarikat Malaysia (SSM) 
or Malaysian  Registrar of Business (ROB).’  
 
 
January 2008 Revision  
 
SECTION 1  
 
Ammendments in words or phrases in the respective sections are in bold 
letters.  
 
1.1  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 12 ‘Drug and cosmetic registration’ changed to ‘drug registration and 
cosmetic  notification ,’ 
 
1.3 
 ‘Control of Drugs and Cosmetics (Amendment) Regulations 2001’ changed 
to ‘Control of  Drugs and Cosmetics …….. 2006 ’ 
 ‘Possessed for sale’ changed to ‘ possessed or administered ’ 
 The entire second paragraph ammended to   
“A ‘product’ as defi ned in the Regulations means: (a) a drug in  a 
dosage  unit or otherwise, for use wholly or mainly by being 
administered to one or more  human beings or animals for a medicinal 
purpose; (b) a drug to be used as an  ingredient of a preparation for a 
medicinal purpose; or (c) cosmetics.”  
 
1.4 
 A separate guideline is available for the application for notification 
(replacing  ‘registration’)  of cosmetic products.  
 
 
2.1 
 A separate guideline for application for the registration of veterinary 
products is available.  
 
3.1 A mendment on the certain categories of OTC:  
 (iii) [3 of OTC antiseptics/ skin disinfectants; lozenges/pastilles; dietary 
supplements; topical  analgesics/ couterirritants; emollients/demulcents; 
keratolytic; topical nasal  decongestants]  
 
4.3.2  
 Deletion of the whole paragraph  in second bullet of 4.3.2 (ii) , ‘External 
personal care……requirement for CFS and GMP certification).  
 
6.4 
 Such products may not be imported, manufactured, sold, supplied or 
possessed or  administered.  
 
6.5.1  
 Any applicant/ marketing authorization holder aggrieved by the decisions of 
the DCA may  make a written appeal to the Minister of Health or the 
Director of Pharmaceutical  Services . 
6.6 Decision of the Minister or the Director of Pharmaceutical Services [Reg 
18] 
The decision of the Minister or the Director of Pharmaceutical Services  
made on any  appeal is final.  
 
8.3  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 13 Deletion of the whole paragrap h since change of colour/shade, 
flavour/fragrance and  shape is allowed.  
 
13.8.2 (i) Full evaluation process  
 For new indication which has been registered in any one of the DCA’s 
eight (8) reference  countries (United Kingdom, Sweden, France, United 
States of America, Australia,  Canada, Japan and Switzerland ) 
 
 
 
 
Appendix 1  
 
No.6  
 Amendment to the whole paragraph - ‘The product registration holder or 
any person  who possesses any registered product shall imform 
immediately the Director of  Pharmaceutical Services of any adverse 
reactions arising from the use of the  registered product.’ [Reg 28]  
 
No.10  
 Amendment to the whole paragraph - ‘The Director of Pharmaceutical 
Services may  issue directive or guidelines to any person or a group 
of persons as he thinks  necessary for the better carrying out of the 
provisions of these Regulations and  which in particular relate to - (a) 
product quality, safety and efficacy; (b) labeling;  (c) change o f 
particulars of a product; (d) transfer of licences; (e) manufacturing;  (f) 
storage includes requirements as to containers; (g) retailing; (h) 
promotion of  sale including product informati on; (i) product recall; (j) 
product disposal; (k) the  cost of product recall or product disposal; (l) 
clinical trials; or (m)records and  statistics pertaining to manufacture, 
sale, supply, import or export of any  products.’ [Reg 29 (1)]  
 
Appendix 4  
 
Type I I, point no.6  
 ‘Replacement of an excipent with a comparable excipient and/or 
change in content  of excipent’  
 
 
 
Section 2 - Guide on how to fill the on -line application form  
 
[7] Product Classification  
 Omission of all External personal care (EPC) pr oduct from abridged 
application since EPC  has been reclassified as Cosmetic  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 14Section D: Label (mockup) for immediate container, outer carton and proposed 
package  insert  
 
 Item 20: Deletion of phrase “For EPCs only, English optional”  
 
December 2007 Revision  
 
Appendix 3  
 
 Reinsertion of the missing specific labeling requirements (label & package 
insert) for Bee  Pollen from November 2007 version  
 Deletion of item 30 : Diluluskan oleh KKM  
 
Appendix 6  
 
 Addition of Nimesulide as ingredients (active) not allowed to b e registered 
by the Drug  Control Authority  
 
Appendix 7  
 
 Addition of Red G as ingredients (excipient) banned /allowed only to 
specific limits  
 
Section D  
 Deletion of the phrase “Diluluskan oleh KKM” for OTC products from the 
information  which should be prese nt on the labeling of the product  
 
 
November 2007 Revision  
 
Appendix 3  
 
 Addition of specific labelling requirement for Glucosamine  
 Addition of specific labeling requirement for Piroxicam  
 Addition of specific labeling requirement for Ceftriazone  
 Addition of  specific labeling requirement of the package insert for :  
I. Alprazolam  
II. Bromazepam  
III. Clobazam  
IV. Diazepam  
V. Flurazepam hydrochloride  
VI. Lorazepam  
VII. Midazolam  
VIII. Nitrazepam  
IX. Triazolam  
X. Zolpidem tartrate  
XI. Zopiclone   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 15 Addition of specif ic labeling requirement of the box and package insert for  
I. Gadoxetic acid  
II. Gadoversetamide  
III. Gadoteric acid  
IV. Gadolinium oxide  
V. Gadodiamide  
VI. Gadobutrol  
VII. Gadobenic acid  
 
 
 
Appendix 6  
 
 Addition of Gatifloxacin and Tegaserod as ingredients (active) not allowed 
to be  registered by the Drug Control Authority  
 
October 2007 Revision  
 
Appendix 3  
 
 Addition of specific labelling requirement for Piroxicam  
 
 
September 2007 Revision  
 
 Addition of :  
Appendix 13 Functional Claims for Health Supplement Products  
 
 
July 2007 Revision  
 
Appendix 3  
 
 Addition of specific labelling requirement for Glucosamine  
 
Appendix 6  
 
 Addition of Gatifloxacin and Tegaserod as ingredients (active) not allowed 
to be  registered by the Drug Control Authority  
 
Appendix 12  
 Addition of :  
Appendix 12.6 Visual / Graphic Labels Requirement for Natural Products  
Appendix 12.7 List of Non Permissible Product Name for Natural Products  
Appendix 12.8 List of Non Permissible Indications for Natural Products  
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 16CONTENT  
 
PREAMBLE  ................................ ................................ ................................ ..........  1 
List of amendments / changes:  ................................ ................................ .............  2 
 
SECTION 1: GENERAL OVERVIEW OF THE DRUG REGISTRATION SYSTEM 
IN MALAYSIA  ................................ ................................ ................................ ..... 19 
 
1. INTRODUCTION  ................................ ................................ ............................  20 
2. DRUG REGISTRA TION  ................................ ................................ .................  21 
3. PROCEDURE FOR PROCESSING NEW APPLICATIONS  ...........................  22 
3.1 Application Type  ................................ ................................ ....................  22 
3.2 Data Requirements ................................ ................................ ................  23 
4. APPLICA TION FORMALITIES  ................................ ................................ ....... 24 
4.1 Responsibility of Marketing Authorization Holder (i.e. the applicant for 
product registration) ................................ ................................ ...............  24 
4.2 Application Fee  ................................ ................................ ......................  25 
4.3 Letter of Authorization and Certification Which Must Accompany 
Applications  ................................ ................................ ...........................  25 
4.4 Multiple Applications  ................................ ................................ ..............  26 
5. PROCESSING OF APPLICATIONS  ................................ ...............................  27 
5.1 Initiation of Review  ................................ ................................ ................  27 
5.2 Stop Clock  ................................ ................................ .............................  27 
6. REGULATORY OUTCOME  ................................ ................................ ............  28 
6.1 Decisions of the DCA  ................................ ................................ ............  28 
6.2 Product Registration Number  ................................ ................................  28 
6.3 Certificate of Registration  ................................ ................................ ...... 28 
6.4 Rejection, Cancellation, Suspension of Registration [Regs. 11]  ............  28 
6.5 Appeal against DCA Decisions [Reg. 18]  ................................ ..............  28 
6.6 Decision of the Minister or the Director of Pharmaceutical Services [Reg. 
18] ................................ ................................ ................................ .........  29 
    6.7     Reapplication of Rejected Products……………………………………….29  
7. MAINTENANCE OF REGISTRATION  ................................ ............................  29 
7.1 Conditions for Registration [Reg. 8(1)]  ................................ ..................  29 
7.2 Validity Period of Registration  ................................ ...............................  29 
8. CHANGE IN PARTICULARS OF REGISTERED PRODUCTS  .......................  30 
9. REPORTING PROBLEMS WITH REGISTERED PRODUCTS  ......................  30 
9.1 Adverse Drug Reactions  ................................ ................................ ........  30 
9.2 Market Surveillance of registered products  ................................ ...........  31 
9.3 Product Complaints  ................................ ................................ ...............  31 
9.4 Product Recalls  ................................ ................................ .....................  31 
10. TERMINATION OF PRODUCT REGISTRATION  ................................ .........  32 
10.1  Terminated by Marketing Authorization Holder  ................................ ..... 32 
10.2  Adulterated Products  ................................ ................................ .............  32 
11. CH ANGE IN MARKETING AUTHORIZATION HOLDER OF A REGISTERED 
PRODUCT  ................................ ................................ ................................ ..........  32 
12. CHANGE IN MANUFACTURING SITE  ................................ .........................  41  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1713. OTHER INFORMATION  ................................ ................................ ...............  43 
13.1  Criteria for registration  ................................ ................................ ...........  43 
13.2  Variants for a Given Product  ................................ ................................ . 43 
13.3  Patented Products  ................................ ................................ .................  43 
13.4  Products for export only  ................................ ................................ .........  44 
13.5  Combination (Combo) Packs  ................................ ................................ . 44 
13.6 Use of HALAL logo  ................................ ................................ ................  45 
13.7  Bioequivalence  ................................ ................................ ......................  45 
13.8  New / additional indication  ................................ ................................ ..... 46 
13.9  Guide for Implementation of Patient Dispensing Pack for Pharmaceutical 
Products in Malaysia.  ................................ ................................ ............  46 
14. TYPES OF APPLICATIONS  ................................ ................................ .........  53 
15. APPENDICES  ................................ ................................ ...............................  54 
 
SECTION 2: GUIDE ON HOW TO FILL THE ON -LINE APPLICATION FORM 
FOR A NEW PRODUCT REGISTRATION  ................................ .......................  205 
 
STEP 1: PRODUCT VALIDATION FORM  ................................ ........................  206 
[1] PRODUCT NAME  ................................ ................................ ...............  207 
[2] DOSAGE FORM ................................ ................................ ..................  207 
[3] ACTIVE SUBST ANCE  ................................ ................................ .........  207 
[4] EXCIPIENT  ................................ ................................ .........................  208 
[5] ANY PORCINE MATERIALS  ................................ ..............................  208 
[6] MANUFACTURER  ................................ ................................ ..............  209 
[7] PRODUCT CLASSIFICATION  ................................ ............................  209 
 
STEP 2: NEW REGISTRATION APPLICATION FORM ….    …………………… 210 
PART I – ADMINISTRATIVE DATA AND PRODUCT INFORMATION ………… 211 
SECTION A: PRODUCT PARTICULARS ………………………………………. 211 
 Product Description :  ................................ ................................ ............  211 
 Pharmacodynamics & Pharmacokinetics (for full evaluation only) ........  211 
 Indication/Usage  ................................ ................................ ...................  211 
 Dose/Use Instruction  ................................ ................................ ............  212 
 Recommended Dose & Route of administration (for full evaluation only)
 212 
 Contraindication ................................ ................................ ....................  212 
 Warnings and Precautions  ................................ ................................ ... 212 
 Drug Interactions  ................................ ................................ ..................  212 
 Side Effects /Adverse Reactions  ................................ ..........................  213 
 Pregnancy and Lactation (for full evaluation only)  ................................  213 
 Signs and Symptoms of Overdose and Treatment  ...............................  213 
 Storage Conditions  ................................ ................................ ...............  213 
 Shelf Life  ................................ ................................ ..............................  213 
 Therapeutic Code (If any)  ................................ ................................ ..... 214 
SECTION B: PRODUCT FORMULA ……. ……………………………………… 214 
 Batch Manufacturing Formula  ................................ ..............................  214 
 Manufacturing process (for abridged evaluation procedure only)  .........  214  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 18 Attachment of In Process Quality Control (for abridged evaluation 
procedure only)  ................................ ................................ ...........................  214 
 Attachment of Finished Product Quality Specification (for abridged 
evaluation procedure only) ................................ ................................ ..........  214 
 Attachment of Stability Data (for abridged evaluation procedure only)  . 215 
SECTION C: PARTICULARS OF PACKING  ................................ .................  215 
SECTION D: LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER 
CARTON AND PROPOSED PACKAGE INSERT  ...............................  216 
PART II, III & IV – QUALITY , NON -CLINICAL (SAFETY) & CLINICAL 
(EFFICACY) DOCUMENTATION  ................................ ................................ ..... 219 
ANNEX A  ................................ ................................ ................................ ..........  220 
Guidelines for the Submi ssion of Protocol of Analysis  ................................ .. 220 
I. General Requirements  ................................ ................................ .........  220 
II. Specific Requirements  ................................ ................................ ....... 221 
Guideline for Submission of Samples to the Drug Analysis Division for 
Laboratory Testing ................................ ................................ ...............  225 
I. Introduction  ................................ ................................ ...........................  225 
II. Requirements  ................................ ................................ ....................  225 
III. Appeal for retesting  ................................ ................................ ...........  226 
Guideline for Submission of Analytical Method Validation Documents ………. 227 
I. Introduction  ................................ ................................ ...........................  227 
II. Requirements  ................................ ................................ ....................  227 
Garis Panduan Mengemukakan Dokumen Validasi Analitikal (Pengujian 
Mikrobiologikal) ................................ ................................ ....................  229 
I. Ujian Kontaminasi Mikrobial  ................................ ................................ . 229 
II. Esei Antibiotik Cara Mikrobiologikal  ................................ ...................  230 
III. Ujian Steriliti ................................ ................................ .......................  231  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 19 
 
 
 
 
 
 
 
 
 
 
SECTION 1: GENERAL OVERVIEW OF THE DRUG 
REGISTRATION SYSTEM  IN MALAYSIA  
(INCLUDING ADMINISTRATIVE PROCEDURES)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 20 
SECTION 1  
1. INTRODUCTION  
 
1.1 The Control of Drugs and Cosmetics Regulations 1984 was gazetted in  
June 1984, with the establishment of the Drug Control Authority (DCA) as  
the licensing authority. The daily operations of drug registration and  
cosmetic notification, togethe r with the attendant monitoring and  
surveillance activities have been delegated to the National 
Pharmaceutical  Control Bureau (NPCB).  
1.2 The guidelines outlined in this document are primarily drawn up in  
accordance to the legal requirements of the Sale of Dru gs Act 1952 and 
the Control of Drugs and Cosmetics Regulations 1984. While every  
effort has been made to include the legal requirements of other related  
legislation, wherever possible, applicants are reminded that it is still their  
responsibility to ensure  that their products duly comply with the  
requirements of this legislation, namely: - 
i. Dangerous Drugs Act 1952 ; 
ii. Poisons Act 1952 ; 
iii. Medicine (Advertisement & Sale) Act 1956 ; 
iv. Patent Act 1983 ; and also  
v. Any other relevant Acts.  
1.3 Regulation 7(1)(a) of the Control of Drugs and Cosmetics  
(Amendment) Regulations 2006 requires all products to be registered  
with the DCA prior to being manufactured, sold, supplied, imported or  
possessed or administered, unless the product is exempted under the  
specific provisions  of the Regulations.  
A ‘product’ as defined in the Regulations means: (a) a drug in a dosage  
unit or otherwise, for use wholly or mainly by being administered to one 
or more human beings or animals for a m edicinal purpose; (b) a drug to 
be used as an ingre dient of a preparation for a medicinal purpose; or (c)  
cosmetics.  
Any change to the above defined parameters may result in the need to  
apply for a new product registration or an application for approval of an  
amendment (variation) to the existing product r egistration.  
Applicants are encouraged to be familiar with the contents of these  
guidelines and the governing legislation before they submit applications 
for drug registration.  
A SEPARATE GUIDELINE IS AVAILABLE FOR THE APPLICATION  
FOR NOTIFICATION OF COSMETIC PRODUCTS.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 21 
2. DRUG REGISTRATION  
 
2.1 Any drug in a pharmaceutical dosage form intended to be used, or capable or 
purported or claimed to be capable of being used on humans or any animals, 
whether internally or externally, for a medicinal purpose is required to be 
registered with the DCA.  
A SEPARATE GUIDELINE FOR APPLICATION FOR THE  
REGISTRATION OF VETERINARY PRODUCTS IS AVAILABLE.  
Medicinal purpose means any of the following purposes:  
i. alleviating, treating, curing or preventing a disease or a pathological 
condition, or symptoms of a disease;  
ii. diagnosing a disease or ascertaining the existence, degree or extent of a 
physiological or pathological condition;  
iii. contraception;  
iv. inducing anaesthesia;  
v. maintaining, modifying, preventing, restoring or inter fering with, the 
normal operation of a physiological function;  
vi. controlling body weight;  
vii. general maintenance or promotion of health or well -being.  
2.2 The Regulations do not apply to the following products : - 
i. diagnostic agents and test kits for laboratory use;  
Diagnostic agents/test kits for laboratory use must be labelled 
‘FOR LABORATORY USE ONLY’ .  Products which are not 
labelled as such shall be deemed to be for human or animal 
use and need to be registered with the DCA.  
ii. non-medicated medical and contraceptiv e devices;  
(i) non-medicated bandages, surgical dressings, plaster, dental 
fillings;  
(ii) instruments, apparatus, syringes, needles, sutures, catheters;  
(iii) Food  - as defined under the Food Act 1983 and Food 
Regulations 1985, includes every article manufactured, sold o r 
represented for use as food or drink for human consumption or 
which enters into or is used in the composition, preparation, 
preservation, of any food or drink and includes confectionery, 
chewing substances and any ingredient of such food, drink, 
confecti onery or chewing substances. This includes food for 
special dietary use for persons with a specific disease, disorder  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 22or medical condition, and food which contain quantities of 
added nutrients allowable under the Food Act and Regulations.  
2.3 Products which are not registered with the Drug Control Authority and are 
intended to be imported for the purpose of clinical trial shall have a Clinical 
Trial Import Licence (CTIL).   [Reg. 12(1)(c)]  
A SEPARATE GUIDELINE FOR APPLICATION FOR CLINICAL TRIAL  
IMPORT LICENCE IS AVAILABLE.  
2.4 Products which are not registered with the Drug Control Authority and are 
intended to be manufactured locally for the purpose of clinical trial shall 
require Clinical Trial Exemption (CTX) from the Director of Pharmaceutical 
Services .   [Reg. 15(5)] . 
2.5 Any person who wishes to manufacture any product solely for the purpose 
of producing a sample for registration should apply for an exemption for 
manufacture of sample. (Applies to locally manufactured products only .)   
[Reg. 15(5)] . 
 
3. PROCEDURE FOR PROCESSING NEW APPLICATIONS  
3.1 Application Type  
An application for a new product registration may be sub -divided into one 
of the following:  
(i) Application for an innovator product  (NCE1 / Biotech)  
 containing a new chemical entity or a biological entity;  
 containing a new combination  of existing 
chemical/biological entity(s);  
 containing existing chemical or biological entity(s) in a 
new dosage form;  
 containing existing chemical or biological entity( s) for use 
by a different route of administration;  
 [   1 has not been registered by the DCA   ]  
(ii) Application for a generic2 product (Controlled Poisons & Non -
Controlled Poisons)  
[2 a generic product is a product that is essentially similar 
to a currently registered product in Malaysia. The term 
generic is not applicable to biological & biotec h 
products ] 
(iii) Application for product registration via the abridged  procedure 
(for certain cate gories3 of  OTC products and also for 
traditional  medicines)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 23[ 3 antiseptics/skin disinfectants; lozenges/pastilles;  
dietary supplements; topical analgesics/counter -
irritants  ; emollients/demulcents; keratolytic;  topical 
nasal decongestants   ]  
Additional Notes : 
 Products containi ng Glucosamine,  Chondroitin and Methylsulfonylmethane 
(MSM)  
a) Products containing Glucosamine as single active ingredient are   
registrable as non -prescription (OTC) product via the full evaluation 
procedure with indicat ion as ‘Adjuvant therapy for osteoarthritis’. 
Products containing Glucosamine in combination with Chondroitin or 
Glucosamine in combination with MSM or Glucosamine in 
combination with MSM and Chondroitin are also registrable as non -
prescription (OTC) produ ct via the full evaluation procedure for 
similar indication.  
b) Products containing Glucosamine either as single ingredients or in 
combina tion with other supplement ingre dients for the use as 
supplements are not allowed to be registered as OTC dietary 
supplements.  
c) Products containing Chondroitin either as single ingredient or in 
combinatio n with other supplement ingredients;  will remain as 
dietary supplement whereby therapeutic claims are not allowed.  
These products’ application s for registration are to be submitted as 
OTC dietary supplements via the abridged procedure.  
d) Products containing MSM either as single ingredient or in 
combination with other supplement ingredients  will remain as dietary 
supplement whereby therapeutic cl aims are not allowed. These 
products’ applications for registration are to be submitted as OTC 
dietary  supplements via the abridged procedure.  
e) Products containing MSM in combinationwith Chondroitin are also 
registrable as OTC dietary supplement via the  abridged procedure 
whereby therapeutic claims are not allowed.  
 
3.2 Data Requirements  
The data required to support an application is divided into:  
a) administrative data (Part I);  
b) data to support product quality (Part II);  
c) data to support product safety (Part III); and  
d) data to support product efficacy (Part IV).  
Data to be submitted will be based on each application type as follows:   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 24Innovator product      –  Parts I to IV (except for existing chemical 
or biological entity(s)  in a new dosage 
form  which will require only Parts I & II, 
together with pharmacokinetic data ) 
  Generic product         –    Parts I & II  
  Abridged procedure  –  Part I only  
Applicants are advised to read the explanatory notes in Section 2  of 
this guidan ce document, and also the relevant ASEAN or ICH 
guidelines and checklists, for full information on product data 
requirement. In order to facilitate the evaluation process, applicants 
should conform to these guidelines. The DCA may in certain cases 
request for supplementary information. The applicant should make 
available the requested information within the specified period. 
Failure to do so may result in the rejection of the application for 
product registration.  
 
4. APPLICATION FORMALITIES  
 
The DCA accepts only web -based on-line submissions via 
http://www.bpfk.gov.my . The applicant f or product registration must be registered 
with Suruhanjaya  Syarikat Malaysia (SSM) or Malaysian Registrar of Business 
(ROB).  The applicant (if said company is not the product owner) 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.  
 
4.1 Responsibility of Marketing  Authorization Holder (i.e. the applicant  for 
product registration)  
4.1.1  The applicant shall be responsible for the product and all  information 
supplied in support of his application for registration of  the product.  
He shall be responsible for updating any information relevant to the  
product/application. The DCA should be informed in a timely  manner 
any change in product information during the course of  evaluation, 
and after product registration, especially if the  information pertains to 
rejection/withdrawal, additional data on  product efficacy and safety 
or current Good Manufacturing Practice  (cGMP) compliance of the 
manufacturers (and repackers, if  applicable).  
4.1.2 Any person who knowingly supplies any false or misleading  
information in connection with his application for registration  
commits an offence under the Control of Drugs and Cosmetics  
Regulations 1984 . [Reg. 8(9)]   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 254.1.3  The marketing authorization holder must assume responsibility for  
the quality, safety and efficacy of h is products.  
 
4.2 Application Fee  
4.2.1  Processing fee  
Every application for registration shall be accompanied with a 
processing fee. The amount of fees is as stipulated in The Control 
of Drugs and Cosmetics (Amendment) Regulations  2002 . 
4.2.2  Other char ges 
The DCA will charge any applicant such costs it may incur f or the 
purpose of carrying out any evaluation investigation  relating to the 
registration of any product. [Reg. 8(3)]  
Any payment made is not refundable once an application has been 
submitted an d payment confirmed. Applications without the correct 
fees will not be processed. [Reg. 8(4)]  
 
4.3 Letter of Authorization and Certification Which Must Accompany  
Applications  
Letters of authorization and certifications should be valid and current at the time of 
submission.  
4.3.1  All applications for registration must be accompanied with the 
following:  
i. Letter of authorization from the product owner. (NOT 
APPLICABLE IF THE APPLICANT IS THE PRODUCT 
OWNER);  
ii. Where a product is contract manufactured, letters of 
authorization of contract manufacture and acceptance 
to and from the manufacturer and also each sub -
contractor, if applicable (e.g. repacker).  
The letter of authorization should be on the product owner’s original 
letterhead and be dated and signed by th e Managing Director, President, 
CEO or an equivalent person who has overall responsibility for the 
company or organization.  
The letter of acceptance from the manufacturer shall comply with similar  
requirements as stated above.  
The letters of authorization and acceptance should state the name of the  
product concerned and also the name and actual plant address of the  
manufacturer(s) involved in the manufacture of the product.  
4.3.2.  Imported products will also need to furnish either a :  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 26i. Certificate of Pharmaceutical Product (CPP) from the  competent 
authority in the country of origin4; OR 
ii. Certification for Free Sale (CFS) and Good Manufacturing Practice 
(GMP) from the relevant competent authorities as deemed 
acceptable by the DCA for the following groups of products:  
 traditional medicines and dietary supplements;  
 
CPPs shall be in the format of the WHO Certification Scheme on the 
Quality of Pharmaceutical Products Moving in International Commerce & 
be issued by the Health Authorities listed in the WHO Certification Scheme 
(list available from the WHO website : http://www.who.int ).  
CPPs issued by EMEA for products registered through the  centralized 
procedure in EU will be accepted.  
CPPs issued by the manufacturer or other authorities are not  acceptable.  
If more than one manufacturer is involved in the manufacture of a  product, 
GMP certification should be available for all the  manufacturers.  
The Drug Control Authority reserves the right to conduct an  inspection on 
any manufacturing site . 
DOCUMENT ON GMP AUDIT OF A FOREIGN MANUFACTURER IS 
AVAILABLE.  
4 In the event a CPP is not available from the country of  manufacture 
e.g. where a product is not licensed for sale in  said country because 
its manufacturer is manufacturing under  contract only for product 
owner from another country, the  following alternatives may be 
considered:  GMP Certification/Manufacturing Licence for the 
manufacturer  from th e relevant competent authority, together with  : 
(1) CPP from the country of the product owner; OR  
(2) CPP from country of release, if (1) is not available.]  
         
4.4 Multiple Applications  
4.4.1  A separate  application is required for each  product i.e. products 
containing the same ingredients but made to different specifications 
(in terms of strength/cont ent of ingredient(s), dosage form, 
description, etc.) or by a different manufacturer shall require 
separate  applications for product registration.  
Note : Different packings (materials) or pack sizes (quantity/volume) 
of a product (including parenteral prepa rations, peritoneal dialysis 
fluids and haemofiltration solutions which are introduced into 
patients’ bodies) made by the same manufacturer to the same 
specifications, formulation and dosage form, shall require only one  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 27application for product registration . The product registration shall be 
for the packings and pack sizes stated in the registration documents 
only.  
4.4.2  An application for a second source may be considered where 
deemed necessary. This second source product shall be the same 
as the first product in  all respects except for the site of manufacture.  
 For biological/Biotechnological products, a third source      
may be considered, where deemed necessary.  
4.4.3  Proprietary products manufactured under licence by different 
manufacturers, or different subsidiaries, or in different countries 
under the same parent firm shall require separate registration.  
 
5. PROCESSING OF APPLICATIONS  
 
5.1 Initiation of Review  
Review of applications will follow a queue system .  There will be separate queues 
for the diffe rent categories of products:  
 NCE  
 Biotech  
 Generics (full procedure)  
 Abridged Procedure Pharmaceuticals (OTC)  
 Traditional Products  
Priority review may be granted where the product is intended for treatment of a 
serious or life -threatening disease (where the likelihood of death is high unless the 
course of the disease is interrupted).  
 
5.2 Stop Clock  
Under review.  
 
5.3  Rejection of Application for Registration of A New Product  
Application for registration of a new product will be rejected if applicant failed to 
submit required additional data within six (6) months  from the last 
correspondence date.  
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 286. REGULATORY OUTCOME  
 
6.1 Decisions of the DCA  
A regulatory decision is made based on the outcome of the evaluation of the 
submitted documentation. An application may be approved or rejected and the 
DCA decision will be sent via e -mail to the marketing authorization holder. 
Applicants are required to c omply with the directions of the DCA within the 
stipulated time as stated in the DCA notification.  
 
6.2 Product Registration Number  
A registration number will be given when a product application is deemed to have 
satisfied the registration requirements of quality, safety and efficacy and is 
granted registration approval by the DCA. The registration number is specific for 
the product registered with the name, identity, composition, characteristics, origin 
(manufacturer) and marketing authorization holder as specified in the registration 
documents. It may NOT be used for any other product.   
The marketing authorization holder (i.e. applicant for product registration) will be 
notified of the DCA decision and given the product registration number assigned 
via e -mail immediately after each DCA meeting. [Reg.8(8)]  
 
6.3 Certificate of Registration  
A certificate of registration with the provisions, conditions, limitations etc. of  the 
registration, shall be issued for the registered product.  
 
6.4 Rejection, Cancellation, Suspension of Registration [Regs. 11 ] 
The DCA may reject, cancel or suspend the registration of any product if there are 
deficiencies in safety, quality or efficacy of the product or failure  to comply with 
conditions of registration.  
Such pro ducts may not be imported, manufactured, sold, supplied or  
possessed or administered.  
 
6.5 Appeal against DCA Decisions [Reg. 18]  
6.5.1  Any applicant/marketing authorization holder aggrieved by the  
decisions of the DCA may make a written appeal to the Mini ster of  
Health or the Director of Pharmaceutical Services. All notice of  
appeals MUST  be made within fourteen (14) days from the date  of 
the DCA notification.  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 296.5.2  A period of 180 days from the date of notice of appeal is given for  
submission of any supp orting data or documents for NCE and  
biotechnology products. A period of 90 days is allowed for other  
products. The appeal is considered closed if all the required  
information is not submitted within the stated time given. Any 
request for extension of this  period will not be entertained.  
 
6.6 Decision o f the Minister or the Director of Pharmaceutical Services  
[Reg. 18]  
The decision of the Minister or the Director of Pharmaceutical Services  made on 
any appeal is final.  
 
6.7      Reapplication of Rejected Products  
Reapplication of rejected products for reason of safety and efficacy will not be 
accepted within 2 years after the rejection. However if the product is registered in 
the reference countries submission of application can be made earlier.  
 
 
7. MAINTENANCE OF REGISTRATION  
 
7.1 Conditions f or Registration [Reg. 8(1)]  
Product authentication is one of the conditions for product registration.  The 
affixing of the security device to product labelling has been  identified as a 
means to verify and authenticate that the product has been  duly registered with 
the DCA. The use of the security device and other  general conditions for 
registration of pharmaceutical products are detailed  in Appendices 1 & 1.1 .  
The DCA may also specify certain special condi tions for registration for a  
particular product or group of products (refer Appendix 2 for list of such  
products ), and may amend any conditions for registration.  
Specific product labelling requirements, for label and/or package insert,  may also 
be laid dow n (refer Appendix 3 for list of affected products).  
The DCA may cancel the registration of any product if the conditions for  
registration are not complied with.  
 
7.2 Validity Period o f Registration  
The registration of a product shall be valid for 5 years or such period as  specified 
in the registration certificate (unless sooner suspended or  cancelled by the DCA).   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 30Renewal of product registration can be done six (6) months prior to the  expiry 
of the validity period of product registration. Upon expiry of the  validity period of 
registration, the module for renewal of product  registration will no longer be 
accessible and application for re -registration  of the product can no longer be 
submitted.  
 
8. CHANGE IN PARTICULARS OF REGISTERED PRODUCTS   
 
8.1 No change in product name, product specifications, packing, indications, 
contents of product label, package insert, or product literature, or any 
relevant particulars of the registered product shall be made without the 
prior approval of the DCA.  
Similarly , prior approval of the DCA is required for changes in excipients, 
such as change in lubricant, preservative, solvent in film coating, etc to 
improve product formulation.  
Explanation/reason for the changes requested should be given. All relevant 
supportin g data related to the above changes such as finished product 
quality specifications (FPQC), Certificates of Analysis (CA), stability data, 
raw material specifications, etc should be updated accordingly.  
The registration of a product may be cancelled if cha nges are made without 
the prior approval of the DCA.  
 
8.2 All necessary documents in accordance to the specified conditions laid 
down for each type of variation (amendment) should be submitted. The 
marketing authorization holder is responsible for ensurin g that all the 
necessary validation has been conducted to demonstrate that the change 
does not reduce the quality, safety or efficacy of the product. (Please refer 
to Appendix 4  for details of the types of variations allowed and the 
conditions and/or suppo rting documents necessary for each type of 
variation defined.)  
 
 
9. REPORTING PROBLEMS WITH REGISTERED PRODUCTS  
 
9.1 Adverse Drug Reactions  
The Malaysian Adverse Drug Reactions Advisory Committee (MADRAC), Sub -
committee of the Drug Control Authority (DCA),  reviews Malaysian reports of 
suspected drug reactions.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 319.1.1  MADRAC encourages health care professionals to report all 
suspected adverse reactions BUT it is a compulsory requirement 
that the marketing authorization holder of a product should inform 
the Director of Pharmaceutical Services  of any adverse reactions to 
the product in accordance to the Malaysian Guidelines for ADR 
monitoring. [Reg.28]  
9.1.2  The product registration can be cancelled if the marketing 
authorization holder fails to inform the D irector of Pharmaceutical 
Services  of any serious adverse reactions upon receipt of such 
reports.  
9.1.3  All labels and package inserts must be amended to include any new 
adverse reactions, warning, precautions etc. within the time frame 
given by the Director of Pharmaceutical Services.  
 
9.2 Market Surveillance of registered products  
9.2.1  Samples of products registe red by the DCA may be taken and 
tested for compliance with official or pharmacopoeia standards or  
specifications agreed by the manufacturer.  
9.2.2  If a sample fails to meet adequate specifications, the marketing  
authorization holder will be issued a warning. Unless the failure is  
serious enough to justify recall of the product, the marketing  
authorization holder has up to 30 days to identify the sour ce/cause  
of quality defect and actions to be taken to improve quality.  
 
9.3 Product Complaints  
9.3.1  The marketing authorization holder should notify the Director of 
Pharmaceutical Services  of any  product quality related problems 
(with registered products)  that the  holder is aware of.  
9.3.1  It is also the responsibility of the prescribers, the pharmacists, as  
well as all other health professionals who come into contact with  the 
drug to report.  
 
9.4 Product Recalls  
9.4.1  Recalls of defective or unsafe prod ucts are instituted by the DCA , 
supported by the Pharmaceutical Services Division, Ministry of 
Health Malaysia.  
9.4.2  The marketing authorization holder is responsible for conducting 
recalls of defective or unsafe products. No recall should take place 
without first consulting/informing the Director of Pharmaceutical 
Services .   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 32 
10. TERMINA TION OF PRODUCT REGISTRATION  
 
10.1 Terminated by Marketing Authorization Holder  
- The marketing authorization holder shall inform the DCA of any decision 
to terminate the registration of a product before the end of the validity of 
such  registration. The onus is on the holder to inform the manufacturer  / 
contract giver.  
- The marketing authorization holder must surrender the product 
registration  certificate immediately t o the DCA.  
- The registration of a product once terminated shall not be reinstated. A  
new application must be submitted should its registration be required  again 
at a later date.  
10.2 Adulterated Products  
Any registered product found to be adulterated;  the following action will be 
taken by Director of Pharmaceutical Services : 
(i) The registration of the product involved will be cancelled and recall 
for the product shall be done immediately.  
(ii) The manufacturer license for those manufacturers involved in the 
manuf acturing of the adulterated product will be revoked for six (6) 
months and for a second/subsequent involvement, it will be revoked 
for one (1) year.  
(iii) All transactions matter (application of product registration, 
application of change of holder, application of change of site) of the 
market authorization holder for the adulterated product will be 
freezed for six (6) months and for a second/subsequent 
involvement, it will be freezed for one (1) year.  
 
 
11. CHANGE IN MARKETING AUTHORIZATION HOLDER OF A 
REGISTERE D PRODUCT  
 
INTRODUCTION  
A product registration (marketing authorisation) may be transferred from the 
existing product marketing authorisation holder (MAH) to another holder using a  
transfer procedure. This administrative procedure allows for a speedy processing  
time and the same product registration number is maintained. The transfer  
procedure must be used where the legal entity of the MAH is changed.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 33 
CONDITONS  
In order to avail of this procedure, the following requirements must be met:  
1. An application  for permission to transfer t he marketing authorisation of a 
product should be submitted by the proposed new MAH.  
 
2. The existing product registration must have a rem aining period of validity of 
at least six (6) months. If the period is less than six (6) mon ths, product 
registration  renewal should be done by the existing MAH before the 
transfer application is  submitted.  
 
3. No change may be made, as part of the transfe r application, to the 
technical data or approved pharmaceutical / pharmacological information, 
including the  texts of the product label and leaflet, other than the name and 
address of the  MAH.  
[Note: any change must be applied for using the variations procedure.]  
 
4. The transferred marketing authorisation is issued for the remaining period 
of validity  of the existing authorisation.  
 
5. The transfer shall come into effect on the day the DCA makes its decision 
on the application. Upon the transfer of product registration (marketing 
Change of  MAH National Pharmaceutical Control Bureau August 2004 
authorisati on) to the  new holder, the authorization issued to the previous 
holder will be cancelled as  the product cannot be marketed simultaneously 
by two different MAHs. The new  i.e. current MAH shall bear responsibility 
for the product.  
6. Where the application does not meet the requirements laid down for this  
administrative transfer procedure or the applicant wishes to obtain a new 
product  registration number, a new application shall be made.  
 
MAKING AN APPLICATION  
The proposed new MAH must submit an application cons isting of the following:  
 Processing fee for the trans fer application (nonrefundable)  
 Transfer application form : 
 Hard copy (BPFK - 430.5); or 
 On-line (change of registration holder tray)  
 Letter of authorization from product owner   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 34 Certification of Registration of company/business of the proposed new 
holder  
 A copy of the agreement concluded between the current MAH, the  
proposed new holder and the product owner to the mutual transfer of the  
product marketing authorisation ( preferably ), 
OR alternativel y, 
Signed statements 1 relating to transfer of authorisation from : 
 Existing product registration holder  
 Proposed new holder  
 Product owner  
 Current confirmation letters (from product owner and contract  
manufacturer) relating to agreement for contract manufacturing, where  
applicable.  
 Latest product label and leaflet.  
 
[Note 1 - Examples of the statements that can be used ar e given as : 
Transfer Form 430.5(1) (statement to be signed by existing holder), &   
Transfer Form 430.5(2) (statement to b e signed byproposed new holder) ] 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 35 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 36 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 37 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 38 
 
 
 
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 39 
 
 
 
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 40 
 
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 4112. CHANGE IN MANUFACTURING SITE  
 
12.1 Applies to change of manufacturing site for part or all of the manufacturing 
process of the product but does not cover changes related to a new site 
where only batch release takes place or to a new packager (secondary 
packaging or labelling) as these changes are covered under applications 
for amendments to the particulars of a registered product (variation).  
The new manufacturing site should comply with current Good 
Manufacturing  Practice (cGMP). Local manufacturing sites are subjected to 
pre-licensing inspections and for manufacturing sites outside Malaysia, 
certification by the competent authority is sufficient. However, the DCA 
reserves the  right to conduct an inspec tion on any manufacturing 
site. 
 Note: Change of manufacturing site for   biological/biotechnological 
products are not allowed. New registration application must be submitted.  
 
12.2 This procedure is only applicable for:  
a) A change in manufacturing site for the same company, 
includingc rationalization in the event of mergers; and  
b) Where  a company which previousl y contracts out the manufacture of its 
product(s) transfers the manufacture of the product to its own  premises.  
A change in manufacturing site betwee n contract manufacturers is not 
routinely allowed but may be considered in a crisis situation (refer Type 
V below).  
 
12.3 There are 5 different types of site change, according to different scenarios 
and hence require different  sets of accompanying documents:  
Type 1 : Change of manufacturing site within Malaysia  
Type 1 is change in the location of the site of manufacture within Malaysia  
only. This change may be due to upgrading of facilities, and/or expansion  
of manufacturing activities or moving to a newly con structed plant. The  
equipment, standard operating procedure (SOP’s), environmental  
conditions (e.g. temperature and humidity) and controls remain the same.  
 
Type II : Change of manufacturing site from foreign country to 
Malaysia  
Type II is change in locatio n of the site of manufacture from outside of  
Malaysia to a location in Malaysia. This change may be due to the ability  of 
the local counterpart to manufacture the product. The equipment,  standard  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 42operating procedure (SOP’s), environmental conditions (e.g.  temperature 
and humidity) and controls remain the same.  
 
Type III : Change to manufacturing site located outside Malaysia  
Type III is a change of location of the site of manufacture to manufacturing  
facilities located outside Malaysia. This may be due to a merger or  
rationalization of manufacturing sites in line with multinationals’  
manufacturing strategies.  
 
Type IV : Change of manufacturing site for special category of  
products  
Type IV is a change of location of the site of manufacture for the following  
categories of products.  
1) Products consisting of vaccines, toxins, serums and allergens,  blood 
products and products derived from biotechnology.  
2) Transfer of manufacturing of an aseptically processed sterile  product 
to a (i) newly constructed or refurbished a septic processing facility  or 
area or (ii) an existing processing facility or area that does not  
manufacture similar approved products (For example, transferring 
the manufacture of a lyophilized product to an existing aseptic 
process area  where no approved  lyophilized products are 
manufactured).  
3) Transfer of a finished product sterilized by terminal processes to a  
newly constructed facility at a different manufacturing site. Once this  
change has been approved, subsequent site changes to the facility 
for similar product types and processes will not be categorized as a 
Type IV.  
 
Type V : Crisis Situation  
Type V is a change of location of the site of manufacturer that is deemed  
necessary due to certain circumstances such as natural disasters, closure  
or suspensio n of premise (revocation of manufacturing licence) and  
matters related to breach of product quality, safety and efficacy. There  may 
be instances where Type V change may involve a new manufacturer.  
Application for type V change of manufacturing site must be made within 
three (3) months  from the date of the crisis occurred.  
 
Types II, III, IV and V require change of manufacturing site application.  
(Please refer to Appendix 5 for details of documentation to be supplied  
with each type of site change ).  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 43 
12.4 Application for change in manufacturing site will be rejected if applicant 
failed to submit required data within six (6) months  from the last correspondence 
date 
 
13. OTHER INFORMATION  
 
13.1 Criteria for registration  
The DCA will register a product only once.  
A product will be registered only if it satisfies ALL requirements of the DCA, 
especially with respect to safety, efficacy and quality of the product.  
Other criteria that may be taken i nto consideration include:  
i. Either that the product is needed or not. Aspects like potential for 
abuse, number of registered products, different dosage form, etc are 
considered;  
ii. Therapeutic advantage.  
 
13.2 Variants for a Given Product  
When variants are registered they should only differ in terms of colour and  
fragrance/flavour as the case may be. The product name shall remain the  same, 
with the addition of an identifying variant name. Each variant will be  registered as 
one (1) product with a different re gistration number.  
Applications for five (5) fragrance/flavours or consequently colour may be 
considered for the following products:  
 
(i) Not containing Scheduled poisons  
only for lozenges; chewable tablets; effervescent powders/tablets; powder; 
granule; ora l liquid; dental preparations (rinses, dentrifices); medicated soaps 
(bar, liquid) and vaginal creams and douches.  
 
(ii)  Containing Scheduled poisons  
only for paediatric oral liquid preparations.  
 
13.3 Patented Products  
(DELETED)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 44 
13.4 Products for expor t only  
13.4.1  The DCA may register the following locally manufactured products 
for export only:  
 Product(s) registered by the DCA but sold in a different colour 
(formulation), shape (eg. animal shapes are allowed for the 
export market), and strength;  
 Product(s) which contain ingredients  / formulations  not allowed 
by the DCA for local use, provided that confirmation in writing is 
obtained from the competent authority of the importing country 
that there is no objection to the importation and sale of the 
formulation in question. Evidence of registration of said 
formulation with the competent authority in importing country 
may be accepted as supporting data.  
13.4.2  Registration of product for export purposes is not necessary if there 
is no change in the for mulation or appearance of the product. An 
“export notification” procedure al lows an applicant to apply for Free 
Sale C ertification for the product whereby the applicant need only 
declare to the DCA the differences in the product for export 
compared to the registered product marketed in Malaysia (such as a 
product being exported under a different name).  
A Certificate of a Pharmaceutical Product will be issued to the 
applicant for the registered product together with an explanation of 
any difference(s) to the  importing country . 
 
13.5 Combination (Combo) Packs  
13.5.1  Products which are packed together in combination for a  therapeutic 
regimen (example for the treatment of Helicobacter  Pylori, Hepatitis 
C, etc.) will be classified as a Combination Pack . 
Product a nd shall be registered as a single product.  
A product which is packed together with diluent(s) is not considered  
as Combination Pack Product.  
Combination pack product must consist of registered  products 
only.  
 Where a combination pack product consists of registered and  
unregistered products, the unregistered product needs to be  
registered first before submitting the registration application for  
the combination pack.  
 Where a combination pack product consists of registered  
products which are sourced from dif ferent product owners,  letters  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 45of authorization from the individual product owners shall  be 
submitted, together with the following product details: - Product 
Name and Product Registration Number.  
13.5.2  Product Labelling  5 
Outer label:  
1) Name of combination pack product  
2) Registration No. of combination pack product  
3) Name and address of manufacturer and marketing authorization  
holder  
4) Batch No. of the combination pack product  
5) Expiry date (shortest)  
Inner label:  
1) Individual Registration No. for each product or Comb ination  Pack 
Registration No.  
2) Individual name for each product or Name of combination pack  
3) Individual Batch No. for each product  
4) Name and address of manufacturer and marketing  authorization 
holder  
5) Individual expiry date for each product  
[5 subject also to requirements stated in Section D: Label  (mockup) for 
immediate container, outer carton and  proposed Package Insert) ] 
 
13.6 Use of HALAL logo  
13.6.1  The use of the HALAL logo on the labels of pharmaceutical  
products will NOT be allowed.  
13.6.2  However use o f the HALAL logo will be considered for traditional  
products, dietary supplements and also cosmetics, for both the  local 
and export market, provided that such products have been  certified 
and approved as HALAL by JAKIM.  
13.6.3  The use of the HALAL logo is based on application made to JAKIM  
and is not a mandatory requirement.  
 
13.7 Bioequivalence  
With the increasing availability of generic products, a mechanism is  required to 
ensure that such products are therapeutically equivalent to the  innovators’ 
product s and are clinically interchangeable. In practice,  demonstration of 
bioequivalence (BE) is generally the most appropriate  method of substantiating  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 46therapeutic equivalence between medicinal  products. A list of drug substances, 
which, when formulated in oral  solid dosage forms, require BE data as a 
prerequisite for registration, has been  established by the DCA (please refer to 
BPFK website at  http://www.bpfk.gov.my . This list is updated based on 
requirements.  
 
13.8 New / additional indication  
13.8.1  New/addit ional indication is defined as an indication which is not  
previously approved for a registered product. This includes a new  
therapeutic indication or indication for new age group (example  
usage in children) and does not include changing/rephrasing of  
sentences.  
13.8.2  For pharmaceuticals, there are 2 types of evaluation process  
available for a new/additional indication application: - 
i. Full evaluation process  
For new indication which has been registered in any one of  the 
DCA’s eight (8) reference countries (United Kingdom,  Sweden, 
France, United States of America, Australia,  Canada, Japan and 
Switzerland);  
ii. Verification process  
For new indication which has been registered in European  
Countries/EMEA (United Kingdom, Sweden and/or France)  and 
one of t he other DCA’s reference countries (United  States of 
America, Australia, Canada and Japan).  
Note : The approved new indication in these countries should be  
the same as that of the proposed new indication.  
13.8.3  For traditional products, new/additional indications  can be  requested 
through an application for a variation to the particulars of  a 
registered product, provided these are low level claims and  
appropriate to the product.  
13.9 Guide for Implementation of Patient Dispensing Pack for 
Pharmaceutical Products in Mala ysia.  
 
13.9.1 Purpose  
 
To provide guidance on the implementation of patient or original dispensing 
pack for pharmaceutical products in Malaysia.  
 
 
13.9.2 Strategic Objective  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 47Improve patient safety by:  
 maintaining product integrity;  
 prevent unnecessary exposure of the product;  
 avoid product contamination due to handling especially in non -GMP 
premise;  
 fewer steps in dispensing process hence less opportunity for errors 
and improvement in efficiency.  
 
 
13.9.3 Definition  
 
Patient dispens ing pack or original dispensing pack is a ready -to-dispense 
pack with sufficient quantity equivalent to an amount not more than one 
month’s supply or per treatment for one patient’s use.  
 
 
13.9.4 Benefits  
 
Key benefits identified:  
 Ensuring patients recogni se how to take medications and the need to 
take medications which will increase compliance.  
 Clearly identifying the medicine, by whom and where it was 
manufactured.  
 Providing complete instructions on the use of the medicine.  
 Original packing will maintain the integrity of the pack therefore 
ensuring stability.  
 Original packing will carry batch number and expiry dates.  
 Prevent mix -ups (or contamination) during repacking and dispensing.  
 Facilitate recall of products since the required information can be found  
on the packs.  
 
13.9.5 Criteria for implementation of patient dispensing packs  
 
 The patient dispensing pack size should be based on the medication, 
intended use, recommended dosage and dosage form sufficient for 
one month’s supply or per treatment for one’ s patient’s use,  
 This guide does not apply to blister or strip packing.  
 Maximum permitted supply is one month but may be less depending 
on the intended use of the medication.  
 The Marketing Authorization Holder (MAH) is responsible to justify the 
proposed patient dispensing pack size based on these criteria as the 
dosing regime for certain medication may equate to high numbers of 
tablets/capsules. Justification should also address the definition of one 
month’s i.e. 28, 30 or 31 days.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 48 Blister or strip packin g is strongly encouraged for solid oral dosage 
forms (e.g. tablets and capsules) and bulk loose packs for supply more 
than a month are not permitted unless justified by the MAH.  
 Oral chemotherapeutics  must be packed in blister packing to minimize 
the conta ct which can avoid the toxic effect of chemotherapy.  
 
13.9.6 Situations where patient dispensing pack is not 
appropriate/applicable  
 
 Injectables , eye, ear and nasal drops, suppositories and pessaries.  
 Products for export.  
 Products under existing tender s upply to government institutions (until 
tender expiry).  
 Drugs, where the risk of issuing more than the amount required by the 
patient outweigh the benefits of the patient dispensing pack e.g. 
products containing substances with potential for abuse or cytotoxic 
agents where precise dosing are required.  
 Drugs where the dosing needs to be tailored according to patient body 
weight e.g. drugs used in oncology, HIV etc  
 Medically critical products and hospital packs for rare diseases with 
very low volumes whe re it is not viable to produce special packs for a 
single market.  
 Products sold with devices with a fixed number of doses are excluded 
from this requirement.  
 Situations where a patient dispensing pack is not appropriate will be 
considered on a case to cas e basis.  
 
 
13.9.7 Other Considerations for Implementation  
 
1. Variation Applications  
Variations to introduce a patient pack size may or may not involve a new 
pack type. All variations need to be submitted to the Variations Unit, 
Centre for Post Registratio n.  
 
Supporting documentation required is:  
 Justification for the new pack size and/or type,  
 Accelerated stability data (3 or 6 months) and stability report for new 
pack types,  
 Commitment to provide complete real time stability data and report 
when availab le. 
      
2. List of products with recommended pack sizes for oral liquid 
preparations and dermatologicals are as in Appendix A and Appendix B 
respectively.  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 493. For tablets and capsules in loose pack, the maximum packing size will 
depend on the highest dosage and frequency per patient’s treatment or 
one month supply.  
 
 
13.9.8 Implementation Timeline  
 
  Implementation of patient dispensing pack needs to be conducted in 
a phased manner as defined by the MAH to ensure smooth transition 
while ensuring no disr uption in supply to patients. Patients dispensing 
packs are effective 1 March 2008  on a voluntary basis and mandated 
from 1 September 2008 .  
 
 All products manufactured from 1 September 2008  regardless 
whether it is imported or locally manufactured  will need to conform to 
the principles of this guide.    
 
 Current bulk packs or non patient dispensing packs already in the 
market will not need to be recovered from the market but will be 
allowed to be depleted.  
 
            
13.9.9 Conclusion  
 
Patient Dispensin g Pack is convenient, safe and improves quality of 
dispensed medicines. It will increase efficiency in dispensing and improve 
safety by reducing the risk and possibility of errors. It will also result in a 
reduction in drug waste and better use of resource s. 
 
13.9.10 Appendix A - ORAL LIQUID PREPARATION MAXIMUM PACK 
SIZE RECOMMENDATIONS FOR PHARMACEUTICAL PRODUCTS  
 
ATC Code  
 Recommended Pack sizes  
R05      Cough & cold preparation  
R05A    Cold preparation  
R05C    Antitussives  
R05D    Expectorants  Max 120ml  
(except for Pholcodine – 90ml)  
R06A   Antihistamines systemic  Max 120ml  
(except for Hydroxyzine HCl 
Syrup - 200ml )  
R03     Anti -asthma & COPD products  
R03A   Beta2 stimulants  
R03B   Xanthines (theophyllines)  Max 120ml  
(except for Procaterol - 250ml)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 50R03C   Non -steroidal respiratory anti -inflammatory 
(ketotifen)  
N02B    Non -narcotic analgesics  Max 120ml  
M01A    Antirheumatics non -steroid  Max 120ml  
H02       Systemic corticosteroids  
H02A    Plain corticosteroids  Max 120ml  
M06A    Anti -inflammatory enzymes  Max 500ml  
A02A     Antacid antiflatulents  
A02B     Antiulcerants  Max 250ml  
A06A     Laxatives  Max 120ml  
(except for Lactulose - 500ml)  
A03       Functional GI disorder drugs  
A03A     Antispasmodic  
A03E    Other GI  combinations (Colimix)  
A03F    Gastroprokinetics (Metoclopramide, 
Motilium)  
A07      Antidiarrhoea  Max 120ml  
 
A04A   Antiemetic + Antinauseants  
N07C   Antivertigo products  Max 120ml  
N03A   Antiepileptics  Max 250ml  
(Except for Sodium Valproate 
Syrup  - 300ml)  
N06A   Antidepressant  & Mood stabilizer  
 
N06D   Anti Dementia  
 
N07D   Anti -Alzheimer products  
 
N05A   Antipsychotics  
 Max 250ml  
 
 
 
Max 20ml for drops  
P01B   Antihelmintics  Max 60ml  
N05C   Tranquillizers/ Anxiolytics  Max 250ml  
A05B   Hepatic protector – lipotropics   Max150ml  
J05      Antivirals for systemic use  
J05B   Antivirals excluding Anti -HIV 
J05C   HIV antivirals  Max 250ml  
J01    Antibiotics systemic  
J01A   Tetracyclines & combination  
J01B   Chloramphenicols + combina tions  
J01C1 Oral broad spectrum Penicillins  Max 120ml   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 51 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 J01D1 Oral Cephalosporins  
J01E   Trimethoprim  combinations  
J01F   Macrolides & similar type  
J01H   Medium & narrow spectrum penicillins  
J01X   Other antibiotics  
J02A    Systemic Antifungals Agents  
N06D    Nootropics  
N06E    Neurotonics & Miscellaneous  Max 125 ml  
G01A1   Trichomonacides  Max 120ml   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 52 
13.9.11  Appendix B – DERMATOLOGICALS PRE PARATION MAXIMUM  
PACK SIZE RECOMMENDATIONS FOR PHARMACEUTICAL   
PRODUCTS  
 
 
ATC Code  
 Recommended Pack sizes  
D01A    Antifungals for topical use  Liquid preparation – max 250ml  
Others – max 60g  
D02A    Emollients and protectives  Non poisons (liquid preparation) – 250ml  
Others - 60g 
Except D02AC Soft paraffin and fat products 
and  
D02AX Other emollients and protectives (Aq. 
Cream) – max 500g  
D03     Preparations for treatment of wounds 
and ulcers  Max 120ml  
D04A   Antipruritics, anesthetics, etc.  
Except D04AA Antihistamines for topic al use 
(not allowed for registration)  Liquid – max 250ml  
Others – 60g 
D05A   Antipsoriatics for topical use  Liquid – max 500ml (with a dispenser).  
Others – max 60g  
Bar – max 100g  
D06A    Antibiotics for topical use  Max 20g  
 Except D06BB Antivirals - Max 10g  
D06B A 01  Silver sulphadiazine for 
management of burns  – 500g  
D07A    Corticosteroids, plain  
D07A    Corticosteroids, plain  
 
D07AA  Corticosteroids, weak (group I)  
 
D07AB   Corticosteroids, moderately potent 
(group II)  
D07AC   Corticosteroids, potent (group III)  
 
D07AD   Corticosteroids, very potent (group IV)   
 
 
D07AA – Max 100g  
D07AB – Max 50g  
D07AC – Max 15g  
D07AD – Max 15g  
D07C     Corticosteroids, combinations with 
antibiotics  
 
D07CA   Corticosteroids, weak, combinations 
with antibiotics   
D07CA – Max 100g  
D07CB – Max 50g  
D07CC – Max 15g  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 53 
D07CB   Corticosteroids, moderately potent, 
combinations with antibiotics  
 
D07CC   Corticosteroids, potent, combinations 
with antibiotics  
D07CD   Corticosteroids, very potent, 
combinations with antibiotics  D07CD – Max 15g  
D08A     Antiseptics and disinfectants   
 Liquid antiseptics/disinfectants – 1L 
Others – max 60g  
D10A    Anti -acne preparations  for topical use  
Except for D10AA Corticosteroids, 
combinations for treatment of acne  Liquid preparation – max 250ml 
(recommended to be used with a dispenser)  
Bar – max 100g  
All others – max 60g  
D11AF   Wart and anti -corn preparations  Max 15ml  
M02A    Topical products for joint and 
muscular pain  Liquid – 250ml  
Others, Max – 60g 
D11AX11   Hyperpigmentation  Max 60g  
 
 
14. TYPES OF APPLICATIONS  
 New product registration  
 Renewal of product registration  
 Change in manufacturing site  
 Change in Marketing Authorization Holder  
 New / additional indication  
 Amendments to particulars of a registered product (variation)  
 Registration of combination pack product  
 Product registration for export only  
 Appeals against DCA decision  
 Withdrawal (of a product registration application prior to its approval)  
 Termination (of product registration)  
 Clinical Trial Import Licence (CTIL)  
 Clinical Trial Exemption   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 54 Exemption for manufacture of sample for purpose of registration (locally 
manufactured products only)  
 
15. APPENDICES  
Appendices  Title Page  
Appendix 1  General Conditions for Registration of Drug Products under the Control of Drugs and 
Cosmetics Regulations 1984   
1.1  Product Identification Chart - for security device labeling  55 
 
57 
Appendix 2  List of a particular product or group of products with special conditions for registration  58 
Appendix 3  Specific labelling requirements (label & package insert)  68 
Appendix 4  Types of variations and supporting documentation required  111 
Appendix 5  Supporting Documentation required for Change in Manufacturing Site Application  121 
Appendix 6  List of ingredients (active) not allowed to be  registered by the Drug Control Authority  124 
Appendix 7  List of ingredients (excipient) banned / allowed only to specified limits  128 
Appendix 8  Permitted colouring agents in pharmaceutical and traditional products  129 
Appendix 9  Guidance Notes for Health Supplement Products  
9.1 Health Supplements  
9.2 Indication  
9.3 Route of Administration  
9.4 Active Ingredients In Health Supplement  
9.5 Maximum Daily Levels of Vitamins and Minerals for Adults allowed in Health 
Supplements  
9.6 Sample  
9.7 Pack Size  
9.8 Labelling Requirement  
9.9 Functional Claims for Health Supplement Products  
9.10 List of Non Permissible Product Name for Health Supplement Products  133 
Appendix 10  Guide to classification of Food -Drug Interface Products  147 
Appendix 11  Guidance specific for OTC External Personal Care Products  149 
Appendix 12  Guidance notes for Traditional Products  
12.1 List of Prohibited Botanicals (Herbs and Herbal Derivatives)  
12.2 List of Wildlife whose use is prohibited in Traditional Products  
12.3 Specific Ingredients Not Allowed to be Registered under Tradisional Medicine  
12.4 Labelling Requirements for Traditional Products Label and Package Insert  150 
151 
162 
181 
182  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 5512.5 Indications Acceptable for Traditional products  
12.6 Quality Control Test Specifications for Traditional Medicine Products  
12.7   Visual / Graphic Labels Requirement  for Natural Product  
12.8   List of Non Permissible Product Name for Natural Products  
12.9    List of Non Permissible Indications for Natural Products  188 
192 
195 
201 
204 
 
 
 
Appendix 1: General Conditions for Registration of Drug Products under the  
Control of Drugs and Cosmetics Regulations 1984  
 
1. Registration Number:  
The product registered with the Registration Number as stated in the Registration  
Certificate shall have the  name, composition, characteristics, specifications and 
origin as specified in the registration documents.  
 
2. Product Particulars:  
The holder of the registration certificate shall supply such documents, items, 
samples, particulars or information as the DC A may require in relation to the 
registered product.  
No change in name, composition, characteristics, origin, specifications,  
manufacturer, packing, indications, labelling, package insert, product literature or  
any relevant particulars of the registered pr oduct shall be made without prior  
approval of the DCA.  
 
3. Labelling:  
The registered product shall be labelled with the Registration Number. The labels  
for the registered product shall comply with all other labeling requirements  
specified by the DCA.  
 
4. Product authentication:  
The registered product shall be affixed with the security device approved by the  
DCA. The said security device, which is serialized, shall be used to authenticate  
and verify that the product is registered with the DCA, and will be a ffixed to each  
unit pack of the product, whether locally manufactured or imported.  
The security device shall be affixed onto the outer packaging of the product, (or,  
where there is no outer packaging, on the immediate packaging), on the front   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 56panel of the product label. None of the product particulars on the label shall be  
covered over by the security device.  
(Please refer to Appendix 1.1 for Product Identification Chart which indicates  
where the security device may be affixed on the product label ) 
 
5. Indications, Special Conditions:  
The registered product shall only be indicated for use as approved by the DCA.  
The importation, manufacture, sale and supply of the registered product shall  
comply with all other specific conditions imposed by the DCA.  
6. Adverse Reactions, Complaints:  
The product registration holder or any person who possesses any registered  
product shall inform immediately the Director of Pharmaceutical Services of any  
adverse reactions arising from the use of the registered product. [Reg 28] 
 
7. Holder of Registration Certificate:  
The holder of the registration certificate shall inform the DCA of any change in his 
name or address.  
 
8. Withdrawal from Registration:  
The holder of the registration certificate shall notify the DCA of any decis ion to 
withdraw the registration of the product and shall state the reasons for the  
decision.  
The holder shall also notify the DCA when he is no longer authorized to be  the 
holder of the registration certificate.  
 
9. Cancellation, Suspension, Amendment by DCA:  
The DCA may, at any time and without assigning any reason suspend or cancel  
the registration of any product, and may amend the conditions to which such  
registration is subject. The holder of the registration certificate shall immediately  
surrender to the DCA the registration certificate upon cancellation or suspension  
of the registration of the product.  
 
10. Director of Pharmaceutical Services  Directions:  
The Director of Pharmaceutical Services may issue directives or guidelines to  any 
person or a group of persons as he think necessary for the better carrying  out of 
the provisions of these Regulations an d which in particular relate to:   
a) product quality, safety and efficacy;  
b) labeling;   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 57c) change of particulars of a  product;  
d) transfer of licences;  
e) manufacturing;  
f) storage includes  requirements as to containers;  
g) retailing;  
h) promotion of sale including  product information;  
i) product recall;  
j) product disposal;  
k) the cost of product  recall or product disposal;  
l) clinical trials; or  
m) records and statistics pertaining  to manufacture, sale, supply, import or 
export of any products.” [Reg 29 (1)]  
 
Appendix  1.1: PRODUCT IDENTIFICATION CHART  
 
 
Numerical notation in line with the numbering for the parameters to be included 
in the product label as identified and  adopted by the ACCSQ -PPWG   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 58Appendix 2: List of a particular product or group of products with special 
conditions for registration  
  
1. ALFENTANIL HYDROCHLORIDE  
(Conditions for Registration)  
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the package insert shall includ e the following boxed 
statement:  
 
 
 
 
2. AMIFOSTINE  
(Conditions for Registration)  
1. The product shall only be sold or supplied to a hospital or institution, having  
the services of registered medical practit ioners with experience in 
oncology.  
2. The following records shall be maintained for the product and well kept  for 
auditing by the Authority :  
 
3. AMIODARONE  
(Conditions for Registration)  
 The product shall be sold or supplied only to: - 
(i) A registered medical practitioner with experience in cardiology, for 
the treatment of his/her patients.  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 59(ii) A hospital or institution maintained by the government, having the 
services of a registered medical practitioner with experience in 
cardiology.  
 
4. AMLODIPINE  
(Conditions for Registration)  
 DELETED  
 
5. BLOOD PRODUCTS  
(Conditions for Registration)  
1. Each batch of the products must comply with WHO requirements for the  
product.  
2. Each batch of the product imported into Malaysia must be accompanied 
with a  Batch Release Certificate from the relevant authority in the country 
of manufacture.  
3. Each batch of the product must be accompanied with a certificate 
confirming  that the blood or plasma used in the production of the lot is 
tested and found to  be negative for HIV antibod y and HbsAg, and that high -
risk donors are  excluded.  
4. Each batch of the product must be accompanied with a certificate of  
analysis . 
 
6. CLOZAPINE  
(Conditions for Registration)  
1. The product shall only be supplied to a patient with a prescription issued by 
Psychiatrist, Neurologist or Physician.  
2. The label shall include the following boxed statement:  
 
 
 
 
 
7. CYCLOSPORIN  
8. DIGITALIS ANTITOXIN  
(Conditions for Registration)  
1. The product shall be sold or supplied for hospital use only.  
2. The label and package insert shall includ e the following boxed statement :- 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 60                      
9. ESMOLOL HCl  
(Conditions for Registration)  
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the package insert shall includ e the following boxed 
statement : 
 
 
 
 
10. ETRETINATE  
(Conditions for Registration)  
1. The product sh all only be sold or supplied to : 
(a) Dermatologist (Skin Specialist) who are gazetted with the Ministry 
of Health, Malaysia, or registered with the Academy of Medicine, 
Malaysia,  Specia list Registry and Approved by the Drug Control 
Authority.  
(b) A hospital or Institution maintained by the government, having the 
services of  a skin specialist or registered medical practitioner with 
experience in dermatology  and approved by the Drug Control 
Authority.  
2. The container of the product shall be labelled in a conspicuous and distinct  
manner, with the following statements:  
“Etretinate/Acitretin is teratogenic.  
Pregnancy must be avoided during treatment and for at least three years  
after completing treatment.”  
3. A proper record of product supplied stating the product name, product  
registration number, name, address and contact number of purchaser  
(prescriber) shall be kept and submitted to the Drug Control Authority  upon 
request.  
4. The following records shall be maintained for the product and well kept for  
auditing by the Authority . 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 61 
 
11. GOSERELIN  
(Conditions for Registration)  
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the package insert shall include the following boxed 
statement :  
 
 
 
 
 
12. HALOFANTRINE  
(Conditions for Registration)  
1. The product shall only be sold or supplied to a hospital, institution or  
organization approved by the Director General of Health.  
2. The product is not recommended for use in pregnant women, 
breastfeeding  mothers and children below two years of age.  
3. The product is not indicated for prophylactic use.  
 
13. HEPARIN GLYCOSAMINOGLYCAN/ NADROPASIN CALCIUM  
(Conditions for Registration)  
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the packaged insert shall include the following boxed  
statement: - 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 62 
 
 
3. The label of the product shall state clearly the source of heparin.  
 
14. HUMAN GROWTH HORMONE  (Somatotropin, Somatropin)  
(Conditions for Registration)  
1. The package insert and any other product literature shall bear adequate  
warning on the possible causal relationship with leukemia.  
2. A proper record of product supplied stating the product name, product  
registration number, name, address and contact number of p urchaser  
(prescriber) shall be kept and submitted to the Drug Control Authority  upon 
request.  
 
15. ISOTRETENOIN  
(Conditions for Registration ) 
1. The product sh all only be sold or supplied to : 
(a) Dermatologist (Skin Specialist) who are gazetted with the Ministry of 
Health, Malaysia, or registered with the Academy of Medicine, 
Malaysia,  Specialist Registry and Approved by the Drug Control 
Authority.  
(b) A hospital or Institution maintained by the government, having the 
services ofa skin specialist or registered medical  practitioner with 
experience in  dermatology and approved by the Drug Control Authority.  
2. The container of the product shall be labelled in a conspicuous and  distinct 
manner, with th e following statements : 
“Isotretinoin is teratogenic.  
Pregnancy must be avoided during treatment and for at least four weeks  
after completing treatment.”  
3. A proper record of product supplied stating the product name, product  
registration number, name, address and contact number of purchaser  
(prescriber) shall be kept and submitted to the Drug Control Authority  upon 
request.  
4. The following records shall be maintained for the product and well kept for  
auditing by the Authority.  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 63            
16. MEFLOQUINE HCl  
(Conditions for Registration)  
1. The product shall only be  sold or supplied to a hospital, institution or  
organization approved by the Director General of Health.  
2. The product is not recommended for use in pregnant women and children  
below two years of age.  
3. The product is not indicated for prophylactic use.  
4. The fo llowing records shall be maintained for the product and two copies  
forwarded monthly to the Secretary, Drug Control Authority, Ministry of 
Health,  together with documentary ev idences:  
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 6417. MEFLOQUINE HCl + PYRIMETHAMINE + SULFADOXINE  
(Conditions for Regis tration ) 
1. The product shall only be sold or supplied to a hospital, institution or  
organization approved by the Director General of Health.  
2. The product is not recommended for use in pregnant women and children  
below two years of age.  
3. The product is not indi cated for prophylactic use.  
4. In the treatment of multiple drug -resistant P.falciparum product is to be 
used  only for patients who are not allergic to sulphonamides.  
5. The following records shall be maintained for the product and two copies  
forwarded monthly to the Secretary, Drug Control Authority, Ministry of Health.  
 
18. METHOTREXATE 1000mg  
(Conditions for Registration)  
1. The product shall be sold or supplied for use by an oncologist only for 
treatment of osteosarcoma and subgroups of Non -Hodgkin's Lymphoma.  
2. The label and package insect shall include the following boxed statement: - 
                      
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 653. The package insert shall include the following statement :- 
'For treatment of osteosarcoma and subgroups of Non -Hodgkin's  
Lymphoma, patients should be closely  monitored during the 
treatment’  
 
19. NALORPHINE  
(Conditions for Registration)  
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the package insert shall include the following boxed 
statement.  
 
  
 
 
20. NALTREXONE HCl  
(Conditions for Registration)  
  
  
 
21. NITRENDIPINE  
(Conditions for Registration)  
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the package insert shall  include the following boxed 
statement.  
 
 
  
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 6622. OESTRADIOL IMPLANT  
(Conditions for Registration ) 
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the package insert shall include the following boxed 
statement.  
 
 
  
 
23. PEMOLINE  
(Conditions for Registration)  
1. The product shall be indicated and used for treatment of childhood 
hyperkinesis  only. 
2. The product shall be sold or supplied to specialist psychiatrist only.  
3. The label and package insert must state in a clear and distinct manner, the  
following boxed statement : 
                     
4. The following records shall be maintained for the product and two copies  
forwarded Monthly to the Secretary, Drug Control Authority, Ministry of 
Health,  together with documentary evidences : - 
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 6724. PENTAMIDINE ISOTHIONATE  
(Conditions for Registration)  
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the package insert shall include the following boxed 
statement.  
 
 
 
 
 
25. PROPOFOL INJECTION  
(Conditions for Registration ) 
1. The product shall  be indicated for the following :- 
Maintenance of general anaesthesia for surgical procedures which do not  
exceed an hour  
2. The product shall be sold or supplied for hospital use only.  
3. The label and package insert shall includ e the following boxed statement :- 
 
4. The package insert shall include the following statement under  precautions  
/ warning :- 
‘There have been very rare reports of epileptiform movement in 
epileptics  and non -epileptics occurring during induction 
orbemergence from  anaesthesia induced by propo fol’ 
5. Any incidence of suscepted or known adverse reactions (local and 
overseas)  shall be reported immediately to the DCA.  
6. The holder shall ensure that each supply of the product is accompanied 
with ADR report form.  
 
26. SOLCOGYN SOLUTION  
(Conditions for Re gistration ) 
1. The product shall be sold or supplied for use by specialists only.  
2. The label and the package insert shall includ e the following boxed 
statement :- 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 68 
 
 
 
27. VACCINES  
(Conditions for Registration)  
1. Each batch of the product must comply with WHO requirements for the 
product.  
2. Each batch of the product imported into Malaysia must be accompanied 
with a batch release certificate from the relevant authority in the country of 
manufacture.  
 
Appendix 3 : SPECIFIC LABELLING REQUIREMENTS (LABEL & PACKAGE 
INSERT ) 
 
1. ACE INHIBITORS  
The following information warning shall be included in the package insert and 
product  literature of pro ducts containing ACE inhibitors : 
WARNING:  
 ACE inhibitors have been shown to be strongly fetotoxic in animal 
studies. Recently available data indicate that ACE inhibitors can 
cause foetal and neonatal morbidity and mortality when administered 
to pregnant woman. The use of these agents during pregnancy is not 
recommended.  
 INCREASED RISK OF BIRTH DEFECTS, FETAL AND NEONATAL 
MORBIDIT Y AND DEATH WHEN USED THROUGHOUT PREGNANCY  
 
USE IN PREGNANCY  
 INCREASED RISK OF BIRTH DEFECTS, FETAL AND NEONATAL 
MORBIDITY AND DEATH WHEN USED THROUGHOUT PREGNANCY  
 
2. ACTIVATED CHARCOAL  
1. The following warnings and precautions shall be included in the package  
insert and product literature of products containing Activated 
charcoal/attapulgite:  
Warnings : 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 69 
Activated charcoal/attapulgite may interfere with the absorption of 
other  drugs, including antibiotics, when administered concurrently.  
Precautions : 
Appropriate fluid and electrolyte therapy should be given to protect 
against  dehydration. Oral rehydration therapy which is the use of 
appropriate fluids  including oral rehydration salts remains the most 
effective treatment for  dehydration due to diarrhoea. The intake of as 
much of these fluids as  possible is therefore imperative.  
2. The following warning shal l be included on the labels : 
          
 
 
3. ALBENDAZOLE & BENZIMIDAZOLE ANTHELMINTICS  
The following warning shall be included on the labels and in the package insert of  
products containing Albendazole  or Benzimidazole anthelmintics : 
SHOULD NOT BE ADMINISTERED DURING CONFIRMED OR SUSPECTED  
PREGNANCY  
 
4. ALFALFA  
For products containing Alfalfa (Medico sativa ), the labels shall include the 
following stateme nt: 
                   
 
5. ALLOPURINOL  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 70The following warning shall be included in  the package insert and product 
literature of products containing Allopurinol : 
Warning:  
Allopurinol should be discontinued at the firs t appearance of skin rash or 
other signs  which may indicate an allergic reaction. Hypersensitivity to  
allopurinol usually appears after some weeks of therapy, and more rarely  
immediately after beginning treatment. In some instances, a skin rash may  
be followed by more severe reactions such as ex foliative, urticarial and  
purpuric lesion as well as Stevens -Johnson syndrome, and/or generalized  
vasculitis, irreversible hepatotoxicity and even death.  
 
6. ALPRAZOLAM  
Please refer to sedative – hypnotic products  
 
7. AMIODARONE  
The label and package inser t of products containing Amiodarone shall include  the 
following boxed statement:  
 
 
8. ANTIDEPRESSANTS  
The following information shall be included in the package insert and product 
literature of products used as antidepressants : 
 
WARNINGS:  
 
Suicidality in Children and Adolescents  
 Antidepressants increase the risk of suicidal thinking and behavior 
(suicidality) in children and adolescents with major depressive disorder 
(MDD) and other psychiatric disorders.  
 Anyone considering the use of an antidepressant in a child or adolescent 
for any clinical use must balance the risk of increased suicidality with the 
clinical need.  
 Patients who are started on therapy should be observed closely for clinical 
worsening, suicidality, or unusual changes in behavior.  
 Families a nd caregivers should be advised to closely observe the patient 
and to communicate with the prescriber.  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 71 A statement regarding whether the particular drug is approved for any 
pediatric indication(s) and, if so, which one(s).  
 
9.        ANTIEPILEPTICS  
The following information shall be included in the package insert and product 
literature of products used as antiepileptics:  
 
WARNINGS  / PRECAUTIONS : 
 
‘Potential for an increase of suicidal thoughts or behaviours’  
 
10. ANTITUSSIVE + EXPECTORANT  
The follow ing statement shall be included on the label and in the package insert of 
combination products contain ing Antitussive and Expectorant : 
“For dry non -productive cough only”  
 
11. ARGININE  
The following warning shall be included on the labels and in the package insert of  
oral p reparations containing Arginine  for health supplement products : 
 
Warning :  
“Arginine is not recommended for pa tients following a heart attack ” 
 
12. ARIPIPRAZOLE  
The following information shall be included in the package insert and product 
literature of products containing Aripiprazole : 
 
WARNING S: 
 
Hyperglycemia and Diabetes Mellitus  
Hyperglycemia in some cases extreme and associated with ketoacidosis or 
hyperosmolar coma or death, has been reported in patients treated with atypical 
antipsychotics. Assessment of the relationship between atypical antipsychotics 
use and glucose abnormalities is complicated by the possibility of an increased 
background risk of diabetes mellitu s in patients with schizophrenia and the 
increasing incidence of diabetes mellitus in the general population. Given this 
confounders, the relationship between atypical antipsychotic use and 
hyperglycemia -related adverse events is not completely understood.  However, 
epidemiological studies suggest an increased risk of treatment -emergent 
hyperglycemia -related events in patients treated with the atypical antipsychotics.  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 72Precise risk estimates for hyperglycemia -related adverse events in patients 
treated with at ypical antipsychotics are not available.  
 
Patients with an established diagnosis of diabetes mellitus who are started on 
atypical antipsychotics should be monitored regularly for worsening of glucose 
control. Patients with risk factors for diabetes mellitu s (e.g. obesity, family history 
of diabetes) who are starting treatment with atypical antipsychotics should 
undergo fasting blood glucose testing at the beginning of treatment and 
periodically during treatment. Any patient treated with atypical antipsychot ics 
should be monitored for symptoms of hyperglycemia including polydipsia, 
polyuria, polyphagia, and weakness. Patients who develop symptoms of 
hyperglycemia during treatment  with atypical antipsychotics should undergo 
fasting blood glucose testing. In so me cases, hyperglycemia has resolved when 
the atypical antipsychotic was discontinued; however, some patients required 
continuation of anti -diabetic treatment despite discontinuation of the suspect drug.  
 
13. ASPARTAME  
The following warning  shall be includ ed on the labels and in the p ackage insert of  
products containing Aspartame : 
 
WARNING : 
 
‘Unsuitable for phenylketonurics’  
 
14. ASPIRIN  
For products containing Aspirin, the following warning shall be included on the  
labels in 4 langu ages (Bahasa Melayu/ Inggeris/C ina/Tamil) and in the form of  
graphics:  
 
Warning : 
NOT TO BE GIVEN TO CHILDREN UNDER 16 YEARS OF AGE  
Amaran : tidak boleh diberi kepada kanak -kanak berumur kurang  daripada 
16 tahun.  
 
15. BEE POLLEN  
For products containing BEE POLLEN , state:  
 This product contains Bee Pollen and may cause severe allergic  reactions, 
including fatal anaphylsctic reactions in susceptible  individuals.  
 Asthma and allergy sufferers may be at greater risks.  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 7316. BENZOYL PEROXIDE  
The following warning shall be included on the labels and in the package insert of  
products containing Benzoyl peroxide : 
 
WARNING :  
Do not use this medication if you have sensitive skin or if you  are sensitive 
to benzoyl peroxide. This product may cause  irritation, characterised by 
redness, burning , itching, peeling, or  possible swelling.  
 
17. BENZYL ALCOHOL  
The following boxed statement shall be included on the labels and in package  
insert of products containing Benzyl alcohol as preservative:  
                        
18. BLACK COHOSH  
The following warning shall be included in the package insert of products 
containing BLACK COHOSH (Cimicifugae Racemosae ): 
Warning : 
Stop taking this product if signs and symptoms suggestive of liver injury  
develop such as tiredness, loss of appetite, yello wing of the skin and eyes  
or severe upper stomach pain with nausea and vomiting or dark urine and  
consult your doctor immediately.  
Patients using herbal medicinal products should tell their doctor about it.  
 
19. BROMAZEPAM  
Please refer to sedative – hypnot ic products  
 
20. BROMPHENIRAMINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Brompheniramine:  
WAR NING (WHEN USED FOR TREATMENT OF  COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 7421. CAMPHOR  
The following warning shall be included on the labels of products containing  
Camphor:  
 
The following warning and precaution shall be included in the package insert of  
products containing Camphor : 
WARNING:  
This product is contraindicated in infants below  2 years of age. Caution  
must be exercised when older children are treated.  
PRECAUTION:  
It is dangerous to place any camphor containing product into the nostril of  
children. A small amount applied this way may cause immediate collapse.  
 
22. CARBAMAZEPINE  
The following warning shall be included in the package insert of products  
containing Carbamazepine:  
Severe dermatologic reactions including Stevens - Johnson syndrome and 
toxic epidermal necrolysis (Lyell’s Syndrome) have been reported with 
carbamazepine. Patients treated with carbamazepine should closely be 
monitored for sign of persensitivity reactions , particularly during the first 
month of therapy. Immediate discontinuation of therapy should be made 
when cutaneous reactions occur.  
 
23. CARBIMAZOLE  
The following statement shall be included in the package insert and product  
literature of products contai ning Carbimazole:  
WARNING:  
Carbimazole may cause white cell disoders such as neutropenia and  
agranulocytosis, which may be fatal if treatment with carbimazole is not  
stopped promptly. These reactions usually occur during the first 3 months  
of therapy, and in most cases, are reversible on stopping treatment. Since  
agranulocytosis can develop very rapidly, periodic leucocyte counts alone  
may not be effective in the early detection of these reactions.  
 
During treatment with carbimazole:  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 751. The patient should be a sked to immediately report signs and symptoms  
suggestive of infection e.g. sore throat, fever, and mouth ulcer.  
2. A white cell counts should be performed if there is any clinical evidence of  
infection.  
3. The drug should be stopped promptly if there is clinical  or laboratory 
evidence  of neutropenia.  
 
 
24. CEFTRIAXONE  
The following additional information shall be included in the package insert and  
product literature of products containing Ceftriaxone:  
Warning:  
Ceftriaxone must not be mixed or administered simulta neously with calcium – 
containing solutions or products, even via different infusion lines.   
Calcium containing solutions or products must not be administered within 48  
hours of last administration of ceftriaxone.  
Cases of fatal reactions with calcium – ceftriaxone precipitates in lung and  
kidneys in both term and premature neonates have been described. In some  
cases the infusion lines and times of administration and calcium – containing  
solutions differed.  
Dosage and Adminstration : Direction for use:  
Do no t use diluents containing calcium, such as Ringer’s Solution or Hartmann’s  
Solution, to reconstitute ceftriaxone. Particulate formation can result.  
 
25. CETRIZINE  
The following precautions shall be included in the package insert of products  
containing Cetrizine:  
PRECAUTIONS : 
Activities Requiring Mental Alertness: In clinical trials the occurrence of  
somnolence has been reported in  some patients taking Cetrizine : due  
caution should therefore be exercised when driving a car or operating  
potentially danger ous machinery.  
 
26. CHELIDONIUM MAJUS  
The following warning shall be included on the labels of products containing  
Chelidonium majus (in 2 languag es - Bahasa Melayu and English) : 
Warning :  
This product may cause adverse reaction to the liver.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 76Amaran :  
Produk ini mungkin boleh menyebabkan kesan  sampingan pada hepar 
(hati).  
 
27. CHLORPHENIRAMINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Clorpheniramine:  
 
WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
28. CHORIONIC GONADOTROPHIN  
The package insert of the product shall include  the following statement : 
‘The ovulation cycle should be monitored with oestriol levels and  
ultrasonography’  
 
29. CLEMASTINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Clemastin e: 
WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
30. CLINDAMYCIN  
1. The package insert must emphasise the possibility of pseudomembranous  
colitis with the use of the drug.  
2. The package insert must include the following boxed or emphasized  
statements/warning:  
i. Clindamycin therapy has been associated with severe colitis which 
may end  fatally.  
ii. It should be reserved  for serious infections where less toxic 
antimicrobial  agents are inappropriate.  
iii. It should not be used in patients with nonbacterial infections, such 
as most  upper respiratory tract infections.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 77iv. Its use in newborns is contraindicated.  
 
31. CLOBAZAM  
Please r efer to sedative – hypnotic products  
 
32. CLOPIDOGREL  
The following information shall be included in the package insert and product 
literature of products containing clopidogrel:  
 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE  
Pharmacogenetics: Based on literature data, patients with genetically reduced 
CYP22C19 function (intermediate or poor metabolisers) have lower systemic 
exposure to the active metabolite of clopidogrel and diminished antiplatelet 
responses, and generally exhibit higher cardiovascular  event rates following 
myocardial infarction than do patients with normal CYP2C19 function.  
 
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS 
OF INTERACTION  
Since clopidogrel is metabolized to its active metabolite by CYP2C19, use of 
drugs that inhibit the activity of this enzyme would be expected to result in 
reduced drug levels of the active metabolite of clopidogrel and a reduction in 
clinical efficacy. Con comitant use of drugs that inhibit CYP2C19 (e.g proton pump 
inhibitors) should be discouraged.  
 
PHARMACOKINETIC PROPERTIES  
The oxidative step is regulated primarily by Cytochrome P450 ISOENZYMES 
2B6, 3A4, 1A1, 1A2 and 2C19.  
 
33. CLOZAPINE  
The following i nformation shall be included in the package insert and product 
literature of products containing Clozapine : 
 
WARNINGS : 
 
Hyperglycemia and Diabetes Mellitus  
Hyperglycemia in some cases extreme and associated with ketoacidosis or 
hyperosmolar coma or death, has been reported in patients treated with atypical 
antipsychotics. Assessment of the relationship between atypical antipsychotics 
use and glucose abnormalities is complicated by the possibility of an increased 
background risk of diabetes mellitu s in patients with schizophrenia and the  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 78increasing incidence of diabetes mellitus in the general population. Given this 
confounders, the relationship between atypical antipsychotic use and 
hyperglycemia -related adverse events is not completely understood.  However, 
epidemiological studies suggest an increased risk of treatment -emergent 
hyperglycemia -related events in patients treated with the atypical antipsychotics. 
Precise risk estimates for hyperglycemia -related adverse events in patients 
treated with at ypical antipsychotics are not available.  
 
Patients with an established diagnosis of diabetes mellitus who are started on 
atypical antipsychotics should be monitored regularly for worsening of glucose 
control. Patients with risk factors for diabetes mellitu s (e.g. obesity, family history 
of diabetes) who are starting treatment with atypical antipsychotics should 
undergo fasting blood glucose testing at the beginning of treatment and 
periodically during treatment. Any patient treated with atypical antipsychot ics 
should be monitored for symptoms of hyperglycemia including polydipsia, 
polyuria, polyphagia, and weakness. Patients who develop symptoms of 
hyperglycemia during treatment  with atypical antipsychotics should undergo 
fasting blood glucose testing. In so me cases, hyperglycemia has resolved when 
the atypical antipsychotic was discontinued; however, some patients required 
continuation of anti -diabetic treatment despite discontinuation of the suspect drug.  
 
34. COLCHICINE  
The following information shall be i ncluded in the package insert and product 
literature of products containing colchicines:  
 
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS 
OF INTERACTION  
 Potential risk of severe drug interactions, including death, in certain 
patients treated with  colchicines and concomitant P -glycopreotein or strong 
CYP3A4 inhibitors such as Clarithromycin, cyclosporine, erythromycin, 
calcium channel antagonists (e.g Verapamil and Diltiazem), telithromycin, 
ketoconazole, itraconazole, HIV protease inhibitors and n efazodone.  
 
 P-Glycoprotein or strong CYP3A4 inhibitors are not to be used in patients 
with renal or hepatic impairment who are taking colchicine.  
 
 A dose reduction or interruption of colchicines treatment should be 
considered in patients with normal renal and hepatic function if treatment 
with a P -glycoprotein or a strong CYP3A4 inhibitor is required . 
 
 Avoid consuming grapefruit and grapefruit juice while using colchicines.  
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 7935. COX -2 INHIBITORS  
The following information shall be included in the pac kage insert for COX -2 
Inhibitors products containing Celecoxib and Etoricoxib:  
1. Limiting the usage of COX -2 Inhibitors as a ‘ Secondary -line therapy’  
2. Contraindication for patients who have risk of cardiovascular disease 
(ischeamic heart disease and stroke) . 
3. Warning to prescriber when prescribing COX -2 Inhibitors to patients with 
risk factors of heart disease, hypertension (high blood pressure), 
hyperlipidemia, diabetes, smoking patient and patient with peripheral 
arterial disease.  
4. Statement on limiting the pe riod and dosing is written as ‘Given the 
association between cardiovascular risk and exposure to COX -2 Inhibitors, 
doctors are advised to use the lowest effective dose for the shortest 
possible duration of treatment’.  
5. Contraindication for patient using Eto ricoxib is written as ‘Contraindication 
for Etoricoxib in patients with hypertension (high blood pressure) whose 
blood pressure is not under control’.  
 
36. CYPROTERONE ACETATE  
The following warning shall be included in the package insert of products  
containing Cyproterone acetate:  
WARNING : 
Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure,  
which has been fatal in some cases, has been reported in patients treated  
with 100mg or more of cyproterone acetate. Most reported cases ar e in men 
with prostatic cancer. Toxicity is dose -related and develops, usually,  several 
months after treatment has begun. Liver function tests should be  performed 
pre-treatment and whenever any symptoms or signs suggestive  of 
hepatotoxicity occur. If hepat otoxicity is confirmed, cyproterone acetate  
should normally be withdrawn, unless the hepatotoxicity can be explained  
by another cause, e.g. metastatic disease, in which case cyproterone  
acetate should be continued only if the perceived benefit outwieghs th e risk. 
 
36. CYTOTOXIC AGENT  
For cytotoxic agents, the label caution should be printed prominently on the  label : 
                            
 
37. DEXBROPHENIRAMINE  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 80The following additional information shall be included in the label and package 
insert of liquid oral products containing Dexbropheniramine:  
WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
38. DEXTROMETHOR PHAN  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Dextromethorphan:  
WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
39. DIAZEPAM  
Please refer to sedative – hypnotic products  
 
40. DICLOFENAC SODIUM  
The following statement shall be included in the package insert and product  
literature of products containing Diclofenac sodium:  
PRECAUTION : 
Severe cutaneous reactions, including Stevens - Johnson syndrome and  
toxic epidermal necrolysis (Lyell’ s syndrome ), have been reported with  
diclofenac sodium. Patients treated with diclofenac sodium should  be 
closely monitored for signs of hypersensitivity reactions. Discontinue  
diclofenac sodium immediately if rash occurs . 
Advers effects: Dermatological : Occasional - rashes or skin eruptions  
Cases of hair loss, bullous eruptions, erythema multiforme, Steve ns- 
Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), and  
photosensitivity reactions have been reported . 
 
41. DICYCLOMINE  
The following boxed warning shall be included on the labels and in the package  
insert of products containing Dicyclomin e:  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 81                       
 
42. DIPHENHYDRAMINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Diphenhydramine:  
WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED  IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
43. DIPHENOXYLATE  
1. The following statements shall be included in the package insert and 
product  literature of pr oducts containing Diphenoxylate:  
 
 
WARNING : 
 
PRECAUTION : 
Appropriate fluid and electrolyte therapy should be given to 
protectagainst  dehydration in all cases of diarrhoea. Oral rehydration 
therapy which is the  use of appropriate fluids including oral 
rehydration salts remains the most  effective treatment for 
dehydration due to diarrhoea. The intake of as much  of these fluids  as 
possible is therefore imperative. Drug -induced inhibition of peristalsis  
may result in fluid detention in the intestine, which may aggravate 
and mask dehydration and depletion of electrolytes, especially in 
young  children. If severe  dehydration of electrolyte imbalance is 
present, diphenoxylate should be  withheld until appropriate 
corrective therapy has been initiated.  
 
2. The following warning shall  be included on the labels:  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 82 
 
 
44. DOPAMINERGIC INGREDIENT  
The following warning/statement related to “Sudden sleep onset” shall be  included 
in the package insert and product literature of products containing  dopaminergic 
ingredients (levodopa, apomorphin e, bromocriptine, cabergoline,  alpha -
dihydroergocryptine, lisuride, piribedil, pramipexole, quinagolide,  ropinirole):  
i. Special  Warning & Special Precautions f or Use:  
……. has been associated with somnolence and episodes of sudden onset,  
particularly in patients with Parkinson’s diseases. Sudden onset of sleep 
during  daily activities, in some cases without awareness or warning signs, 
has been  reported very rarely. Patients must be informed of this and 
advised to exercised  caution while driving or operating machines during 
treatment with ……. Patients  who have experienced somnolence and/or an 
episode of sudden sleep onset  must refrain from driving or operating 
machines. Furthermore a reduction of  dosage or termination of therapy 
may beconsidered.  
 
ii. Effects on Ability to Drive and Use Machines:  
Patients being treated with ……. and presenting with somnolence and/or 
sudden  sleep episodes must be informed to refrain from driving or 
engaging in activities  where impaired alertness may put themselves or 
others  at risk of serious injury or  death (e.g. operating machines) until such 
recurrent episodes and somnolence  have resolved (see also section on 
special warnings and special precautions for  use).  
iii. Undesirable Effects:  
……. is associated with somnolence and has been associated very rarely 
with excessive daytime somnolence and sudden sleep onset episodes.  
 
45. EPHEDRINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Ephedrine:  
WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 83 
46. FAMOTIDINE  
(Dosage adjustment in Moderate or Severe Renal Impai rment) The following  
statement shall be included in the package insert of products containing  
Famotidin e: 
i. Under DOSAGE : dosage adjustment is required for patients with moderate 
to severe renal insufficiency.  
 Since CNS adverse effects have been reported in patients with 
moderate to  severe renal insufficiency, to avoid excess 
accumulation of the drug, the dose  of famotidine may be reduced to 
half the recommended dose or the dosing  interval  may be prolonged 
to 36 -48 hours as indicated by the patient’s clinical  response.  
ii. Under PRECAUTIONS : As elderly patients are more likely to have  
decreased clearance of famotidine, care should be taken in dose selection  
and it may be useful to monitor renal function.  
 
47. FIBRATES  
The following statement shall be included in t he package insert of products  
containing Fibrates (Clofibrate, Bezafibrate, Ciprofibrate, Etofibrate, Fenofibrate,  
Simfibrate etc.)  
Under Drug Interaction : 
Concurrent use of lovastatin (or other HMG -CoA reductase inhibitors) may cause  
severe myositis and myoglobinuria.  
 
48. FLUCLOXACILLIN  
The following warning shall be included in the package insert of pro ducts 
containing Flucloxacillin:  
 
 
49. FLUORIDE  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 84All toothpastes containing Fluorides should be labelled with the following  
additional information:  
1. Direc tions on use  
 Do not swallow – spit and rinse after use.  
2. For children below 6 years  
 Use a pea -sized amount of toothpaste (less than 5mm).  
 Supervise child’s brushing.  
3. Directions on dental health  
 Brush at least twice a day.  
 Restrict the amount and frequency of sugary food.  
 Visit your dentist at least once a year.  
4. Graphics as shown:  
 Child’s use  
 Adult’s use  
 
 
 
50. FLURAZEPAM HYDROCHLORIDE  
Please refer to sedative – hypnotic products  
 
51. GADOBENIC ACID  
Please refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETIC  
RESONANCE IMAGING  
 
52. GADOBUTROL  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 85Please refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETIC  
RESONANCE IMAGING  
 
53. GADODIAMIDE  
Please refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETIC  
RESONANCE IMAGING  
 
54. GADOLINIUM OXIDE  
Please refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETIC  
RESONANCE IMAGING  
 
 
55. GADOTERIC ACID  
Please refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETIC  
RESONANCE IMAGING  
 
56. GADOVERSETAMIDE  
Please refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETIC  
RESONANCE IMAGING  
 
57. GADOXETIC ACID  
Please refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETIC  
RESONANCE IMAGING  
 
58. GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETIC  
RESONANCE IMAGING  
The following additional information shall be included for the products containing:  
1. Gadoxetic acid  
2. Gadoversetamide  
3. Gadoteric acid  
4. Gadolinium oxide  
5. Gadodiamide  
6. Gadobutrol  
7. Gadobenic acid  
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 86Outer Carton : 
 
- Exposure to gadolinium – based contrast agents (GBCAs) increases the 
risk for Nephrogenic Systemic Fibrosis (NSF) in  patients with:  
 acute or chronic severe renal insufficiency (glomerular filtration 
rate  < 30mL/min/1.73m²), or  
 acute renal insuficiency of any severity due to the hepato -renal 
syndrome or in the perioperative liver transplantation period.  
 
- NSF is a debilitating and sometimes fatal disease affecting the skin, 
muscle, and internal organs  
 
- Avoid use of GBCAs unless the diagnotic information is essential and not 
available with non -contrast enhanced magnetic resonance imaging (MRI).  
 
- Screen all p atients for renal dysfunction by obtaining a history and/or 
laboratory tests.  
 
- When administering a GBCA, do not exceed the dose recommended in 
product labelling. Allow sufficient time for elimination of the GBCA prior to 
any readministration.  
 
  
 
 
- NSF is a debilitating and sometimes fatal disease affecting the skin, 
muscle, and internal organs  
 
- Avoid use of GBCAs unless the diagnotic information is essential and not 
available with non -contrast enhanced magnetic resonance imaging (MRI).  
 
- Screen all p atients for renal dysfunction by obtaining a history and/or 
laboratory tests.  
 
- When administering a GBCA, do not exceed the dose recommended in 
product labelling. Allow sufficient time for elimination of the GBCA prior to 
any readministration.  
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 87Package Insert:  
 
 
- Among the factors that may increase the risk for NSF are repeated or higher 
than recommended doses of a GBCA.  
 
- For patients receiving hemodialysis, healthcare professionals may consider 
prompt hemodialysis following GBCA administration in order to enhance the 
contrast agent’s elimination. However, it is unknown if hemodialysis prevents 
NSF.  
 
- Determine the renal fun ction of patients by obtaining a medical history of 
conducting laboratory tests that measure renal function prior to using GBCA.  
 
- The risk, if any, for developing NSF among patients with mild to moderate 
renal insufficiency or normal renal function is unkn own.  
 
- Post-marketing reports have identified the development of NSF following 
single and multiple administrations of GBCAs.  
 
 
59. GENTAMICIN –TOPICAL   
(TOPICAL PREPARATIONS)  
The following boxed statement shall be included in the package insert of topical  
Gentamicin preparations : 
 
              
 
60. GINSENG  
The following statements shall be included on the labels and in the package  insert 
of products containing Ginseng (including all Panax genus):  
a) Safe use of ginseng in pregnant women and children has not been  
established.  
b) Do not exceed the stated dose.  
c) Safety on long term use has not been established.  
 
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 8861. GLUCOSAMINE  
The following statement shall be included in the package insert and product  
literature of products containing Glucosamine:  
Side effects:  
 Cardiovascular:  
Peripheral oedema, tachycardia were reported in a few patients following 
larger  clinical trials investigating oral administration in osteoarthritis. Causal 
relationship  has not been established.  
 Central nervous system:  
Drowsiness, headache, insomnia have been observed rarely during 
therapy (less  than 1%).  
 Gastrointestinal:  
Nausea, vomiting, diarrhoea, dyspepsia or epigastric pain, constipation,  
heartburn and anorexia have been described rarely during oral therapy with  
glucosamine.  
 Skin: 
Skin reactions such as erythema and pruritus have been reported with  
therapeutic administration of glucosamine.  
 
62. HIV PROTEASE INHIBITORS  
The following additional information shall be included in the package insert under  
section on ‘Adverse Reactio ns’ of products con taining HIV Protease inhibitors : 
ADVERSE REACTIONS  
“Although a causal relationship has not been definitively established, protease  
inhibitors may contribute to increase in blood sugar levels and even diabetes in  
HIV patients. Close monitoring of blood glucose level is recommended”.  
 
63. HYDROQUINONE  
The following warning shall be included on the outer labels of products  containing 
Hydroquinone : 
WARNING  
Some users of this product may experience skin irritations.  Should 
this occur, sto p using and consult a medical doctor.  
For hydroquinone products that do not contain any sunscreening agent, a  
statement should be included in the package insert to advise users to either use  a 
sunscreening agent or protect themselves from sunlight or to us e the products  
only at night.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 89 
64. IMMUNOSUPPRESANTS  
The following information shall be included in the package insert and product 
literature of products used as immunosuppressants:  
 
WARNINGS AND PRECAUTIONS  
Immunosuppressed patients are at increased risk for opportunistic infections, 
including activation of latent viral infections. These include BK virus associated 
nephropathy which has been observed in patients receiving immunosupplresants. 
These infections may lead to serious, including fatal outcomes.  
 
65. INSULIN  
The label of the product shall state clearly the source of insulin.  
 
66. KAOLIN, PECTIN, KAOLIN -PECTIN  
1. The following warning and precautions shall be included in the package insert  
and product  literature of products containing ka olin and/or pectin : 
WARNING : 
                         
 
 
Severe constipation, which may lead to fecal impaction, may rarely occur in  
children and the elderly patients taking kaolin and pectin. Kaolin and pectin may  
interfere with the absorption of other drugs, including antibiotics, administered  
concurrently.  
PRECAUTIONS : 
Appropriate fluid and electrolyte therapy should be given to protect  against  
dehydration. Oral rehydration therapy - which is the use of appropriate  
fluids including oral rehydration salts - remains the most effective  treatment 
for dehydration due to diarrhoea. The intake of as much of these  fluids as 
possible is therefore  imperative.  
2. The following warning shall be included on the labels : 
                              
 
Kaolin/Pectin/Kaolin -pectin is not recommended 
for children under 6 years of age   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 90 
67. KETOROLAC TROMETHAMOL  (Ketorolac tromethamine)  
The following statements shall be included in the package insert and product  
literature of products c ontaining Ketorolac tromethamol : 
 
1. The product shall  be indicated for the following : 
For short -term management of moderate to severe acute post -operative 
pain following surgical procedures associated with low risk of 
haemorrhage.  
 
2. Dosage and duration of treatment  
Parenteral administration: The starting dose should be 10mg with 
subsequent  doses of 10 -30mg four to six hourly as required. The lowest 
effective dose should  be used. The total daily dose of 90mg for the non -
elderly and 60mg for the elderly  shoul d not be exceded. Maximum duration 
of parenteral treatment is 2 days for  all age groups. In patients who have 
received parenteral ketorolac and are  converted to oral tablets, the total 
combined daily dose of all forms of ketorolac  should not exceed 90mg fo r 
non-elderly and 60mg for the elderly. Maximum  duration of treatment for 
the oral formulation is 7 days.  
 
3. Contraindications to include:  
 A history of peptic ulceration or gastrointestinal bleeding  
 A history of haemorrhagic diathesis  
 A history of confirmed or suspected cerebrovascular bleeding  
 Operations associated with a high risk of haemorrhage  
 A history of asthma  
 Moderate or severe renal impairment (serum creatinine > 
160mol/L)  
 Hypovolaemia or dehydration from any cause  
 Hypersensitivity to NSAIDs or aspi rin 
 During pregnancy, labour, delivery or lactation  
 Concomitant administration with other NSAIDs, anticoagulant 
including low  dose heparin  
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 9168. LINCOMYCIN  
For all products containing Lincomycin:  
1. The package insert must emphasize the possibility of pseudomembranous  
colitis with the use of the drug . 
2. The package insert must include the following boxed or emphasized 
statement / warning : 
i. Lincomycin therapy has been associated with severe colitis which 
may end  fatally.  
ii. It should be reserved for serious inf ections where less toxic 
antimicrobial  agents are inappropriate.  
iii. It should not be used in patients with nonbacterial infections, such 
as most  upper respiratory tract infections.  
iv. Its use in newborns is contraindicated.  
 
69. LIQUID PARAFFIN  
The following sta tement shall be included on the labels of  products contain ing 
Liquid paraffin as laxative : 
 Not recommended for use in children below 3 years of age;  
 Not recommended for use in pregnant women;  
 Repeated use is not advisable;  
 Consult your doctor if laxatives are needed every day, if  you have 
persistent  abdominal pain or have a condition which makes swallowing 
difficult.  
 
70. LOPERAMIDE  
1. The following warning and precautions shall be included in the package  
insert and product literature of products containing Loperam ide: 
WARNING : 
            
PRECAUTION : 
Appropriate fluid and electrolyte therapy should be given to protect 
against  dehydration in all cases of diarrhoea. Oral rehydration 
therapy which is the  use of appropriate fluids including oral 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 92rehydration sal ts remains the most  effective treatment for 
dehydration due to diarrhoea. The intake of as much  of these fluids as 
possible is therefore imperative. Drug -induced inhibition  of peristalsis 
may result in fluid retention in the intestine, which may  aggravate and 
mask dehydration and depletion of electrolytes. If severe  dehydration 
or electrolyte imbalance is present Loperamide should be  withheld 
until appropriate corrective therapy has been initiated.  
2. The following warning shall be included on the  labels : 
                 
 
71. LORATADINE  
The following warning shall be included in the package insert and  product 
literature of  products containing Loratadine : 
          
 
72. LORAZEPAM  
Please refer to sedative – hypnotic products  
 
73. METHYL SALICYLATE  
The following statements shall be included in the package insert and product  
literature of topical preparation s containing methyl salicylate ≥5% 
Under Cauti on: 
This product contains methyl salicylate and when applied or rub on to the  
skin, can be absorbed thro ugh the skin into the blood. For patients taking  
warfarin, excessive application on to the skin for muscle or joint pains may  
increase the chances of bleeding.  
 
 
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 9374. METHYLPHENIDATE HCL  
The following boxed statement shall be included on the labels and in the package  
insert of products  containing Methylphenidate HCl : 
 
 
 
 
75. METOCHLOPRAMIDE  
The following statements shall be included in the package insert of products  
containing Metoclopramide : 
a) Under Dosage:  
Total daily dose of metoclopramide, especially for  children and young  
adults, should not normally exceed 0.5mg/kg body weight.  
b) Under Warning:  
Avoid doses exceeding 0.5mg/kg/day.  
Extrapyramidal effects, especially dystonic reaction of 
metoclopramide are  more likely to occur in children shortly after 
initiation of therapy, and  usually with doses higher than 0.5mg per kg 
of body weight per day.  
 
76. MICONAZOLE  
The following warning shall be included on the labels and in the  package insert of 
intravaginal pre parations containing Miconazole : 
                   
77. MIDAZOLAM  
The following statements shall be included in the package insert and product  
literature of IV preparations containing Midazolam : 
WARNING:  
IV Midazolam has been associated with severe respiratory  depression and 
respiratory arrest, especially when used for conscious  sedation. In some 
cases, where this was not recognized promptly and  treated effectively, 
death or hypoxic encephalopathy resulted. IV  Midazolam should be used 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 94only in hospital or ambulatory care settings that  prov ide for continuous 
monitoring of respiratory and cardiac function.  Assure immediate 
availability of resuscitative  drugs, equipments, appropriate antidote and 
personnel trained in their use.  Dosage of IV Midazolam must be 
individualized for each patient. Lower  doses are usually required for elderly, 
debilitated or higher risk surgical  patients. When Midazolam is administered 
intravenously for conscious  sedation, it should be injected slowly (over at 
least 2 minutes ); it should  not be administered by rapid or single bolus IV 
injection because of  respiratory depression and/or arrest, especially in 
elderly or debilitated  patients. The intial dose may be as little as 1mg, but 
should not exceed  2.5mg in a normal healthy adult; administer over at  least 
2 minutes and allow additional 2 or more minutes to fully evaluate  sedative 
effect. If further titration is necessary, use small increments to the  
appropriate level of sedation, allowing an additional 2 or more minutes  after 
each increment  to fully evaluate sedative  effect. See Dosage  Administration 
for complete dosing information.  
Please refer to sedative – hypnotic products for additonal information  
 
78. MINOXIDIL SCALP APPLICATION  
The label and the package insert shall include the following statement:  
To be supplied only on the prescription of a registered medical practitioner.  
 
79. NIFEDIPINE  
The following statement shall be included in the package insert of “short acting” 
Nifedipine products:  
WARNING / PRECAUTION:  
“Several well documented studies have descr ibed profound hypotension, 
myocardial infarction and death when immediate release nifedipine capsules 
are used sublingually for acute reduction of blood pressure”.  
DOSAGE:  
 Lower dose may be required in elderly patients as a result of reduced drug 
clearance.  
 For hypertension, the dose used should not exceed 60mg daily.  
 
80. NITRATES  
The following statements shall be included in the package insert of all “ NITRATES 
FOR STABLE ANGINA PECTORIS ”: 
a) An appropriate statement concerning the development of tol erance (under 
precaution section). A suggested statement would be as follows: 
‘Development of tolerance may occur with all forms of nitrate therapy  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 95particularly with the long acting preparations that maintain continuously high 
plasma nitrate concentration’ . 
b) An appropriate recommendation on dosage regimens. The recommended 
dosage regimens should be one that is able to provide a low -nitrate period or a 
nitrate -free period of 8 -12 hours every 24 hours to prevent the development of 
tolerance and thus maintain t he antianginal effects.  
 
81. NITRAZEPAM  
Please refer to sedative – hypnotic products  
 
82. NORFLOXACIN  
The following precautions shall be included in the package insert  of products 
containing Norfloxacin:  
i. Should not be use d in children or pregnant women  
ii. Phototoxicity may occur  
 
83. NORMAL GLOBULIN IM  
The following warning shall be included in the package insert of Normal globulin  
IM preparations : 
Do not administer this preparation intravenously because of potential for serious  
hypersensitivity reactions.  
 
84. NOSCAPINE  
 
1. The following contraindication to be disclosed prominently on the  labels 
of products containing Noscapine :  
       
2. The following warning and precautions shall be included in the product  
literature and package inserts : 
WARNINGS:  
Experimental data now suggests that noscapine may exhibit a 
mutagenic  effect in vitro. Because of the possible consequent risk to 
the developing  foetus, the products containing noscapine is 
contraindicated in women of  child bearing potential, therefore 
pregnancy should be excluded before  treatment, and effective 
contraception maintained throughout treatment  with such products.  
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 96 
PRECAUTIONS:  
In view of potential mutagenicity shown in vitro, potential risks 
should be  balanced against anticipated benefits whe n treating 
children and neonates . 
 
 
85. NSAID  
The following warning shall be included in the package insert of products  
containing N SAID including COX -2 Inhibitors:  
WARNING : 
RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID  
Serious GI toxicity such as bleeding, ulceration and perforation can occur at any  
time, with or without warning symptoms, in patients treated with NSAID therapy.  
Although minor upper GI problems (e.g. dyspepsia) are common, usually  
developing early in theraphy, prescribers sh ould remain alert for ulceration and  
bleeding in patients treated with NSAIDs even in the absence of previous GI tract  
symptoms.  
Studies to date have not identified any subset of patients not at risk of developing  
peptic ulceration and bleeding. Patients w ith prior history of serious GI events  and 
other risk factors associated with peptic ulcer disease (e.g. alcoholism,  smoking, 
and corticosteroid therapy) are at increased risk. Elderly or debilitated  patients 
seem to tolerate ulceration or bleeding less th an other individuals and  account for 
most spontaneous reports for fatal GI events.  
 
86. OLANZAPINE  
The following information shall be included in the package insert and product 
literature of products containing Olanzapine : 
 
WARNINGS : 
 
Hyperglycemia and Diabetes Mellitus  
Hyperglycemia in some cases extreme and associated with ketoacidosis or 
hyperosmolar coma or death, has been reported in patients treated with atypical 
antipsychotics. Assessment of the relationship between atypical ant ipsychotics 
use and glucose abnormalities is complicated by the possibility of an increased 
background risk of diabetes mellitus in patients with schizophrenia and the 
increasing incidence of diabetes mellitus in the general population. Given this 
confound ers, the relationship between atypical antipsychotic use and 
hyperglycemia -related adverse events is not completely understood. However, 
epidemiological studies suggest an increased risk of treatment -emergent 
hyperglycemia -related events in patients treate d with the atypical antipsychotics.  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 97Precise risk estimates for hyperglycemia -related adverse events in patients 
treated with atypical antipsychotics are not available.  
 
Patients with an established diagnosis of diabetes mellitus who are started on 
atypical  antipsychotics should be monitored regularly for worsening of glucose 
control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history 
of diabetes) who are starting treatment with atypical antipsychotics should 
undergo fasting blood  glucose testing at the beginning of treatment and 
periodically during treatment. Any patient treated with atypical antipsychotics 
should be monitored for symptoms of hyperglycemia including polydipsia, 
polyuria, polyphagia, and weakness. Patients who deve lop symptoms of 
hyperglycemia during treatment  with atypical antipsychotics should undergo 
fasting blood glucose testing. In some cases, hyperglycemia has resolved when 
the atypical antipsychotic was discontinued; however, some patients required 
continuati on of anti -diabetic treatment despite discontinuation of the suspect drug.  
 
87. PARACETAMOL  
The following warning shall be included in the package insert, product literature  
and on the labels of products containing paracetamol : 
The following warning shall be disclosed prominently on the labels : 
                                  
 
88. PELARGONIUM SIDOIDES  
The following warning shall be included on the labels and in the package insert of  
products containing Pelargonium Sidoides:  
WARNING : 
IN VERY RARE CASES, P ELARGONIUM SIDOIDES MAY CAUSE 
HYPERSENSITIVITY REACTIONS.  
 
89. PENICILLIN  
The following statement shall be included on th e labels of penicillin products : 
‘Not to Be Used in Patients with Known hypersensitivity to Penicillin ’ 
 
90. PHENIRAMINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Pheniramine:  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 98WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
91. PHENYLEPHRINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Phenylephrine:  
WARNING (WHEN USED FOR TREATMENT OF COUGH AND C OLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
92. PIROXICAM  
The following additional information shall be included in the package insert and  
product literature of products containing Piroxicam:  
WARNING AND PRECAUTIONS : 
 TREATMENT SHOULD ALWAYS BE INITIATED BY A PHYSICIAN  
EXPERIENCED IN THE TREATMENT OF RHEUMATIC DISEASES.  
 USE THE LOWEST DOSE (NO MORE THAN 20MG PER DAY) AND FOR 
THE SHORTEST DU RATION POSSIBLE. TREATMENT SHOU LD BE 
REVIEWED  AFTER 14 DAYS.  
 ALWAYS CONSIDER PRESCRIBING A GASTROPROTECTIVE AGENT.  
CONTRAINDICATIONS : 
 PIROXICAM SHOULD NOT BE PRESCRIBED TO PATIENT WHO ARE 
MORE  LIKELY TO DEVELOP SIDE EFFECTS, SUCH AS THOSE WITH A 
HISTORY  OF GASTRO -INTESTINAL DISORDERS ASSOCIATED WITH 
BLEEDING, OR  THOSE WHO HAVE HAD SKIN REACTIONS TO OTHER 
MEDICINES.  
 PIROXICAM SHOULD NOT BE PRESCRIBED IN ASSOCIATION WITH 
ANY OTHER NSAID OR AN ANTICOAGULANT.  
 
93. PROMETHAZINE HCL  
The following additional inform ation  shall be included in the label and package 
insert of liquid oral products containing Promethazine HCL:  
WARNING   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 991. “IT (BRAND OR GENERIC NAMES) SHOULD NOT BE USED IN PEDIATRIC 
PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL 
FOR FATAL RESPIRATORY DEPRESSION”.  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
 
94. PROPAFENONE  
The following warning shall be included in the package insert of products  
containing propaf enone : 
Propafenone is not recommended for treatment of less severe arrhythmias  
such as nonsustained ventricular tachycardias or frequent premature  
ventricular contractions even if the patients are symptomatic, because of  
recent evidence in the US  of increase mortality in patients with non -
lifethreatening  arrhythmias who were treated with encainide and flecainide.  
 
95. PROPOFOL  
The following warning shall be included in the package insert of products  
containing Propofol:  
WARNING:  
Propofol is not re commended for paediatric general anaesthesia and  
sedation because its safety and effectiveness in these patients have not  
been established. There have been recent reports of adverse cardiac  events 
and deaths associated with its use in paediatric intensive care.  Although 
there is no evidence of a causal link of death  with propofol in these cases, 
the drug could not be ruled out as a  contributing factor. Until further data 
establishing its safety and delineating  its appropriate dose range are 
available, propo fol should not be used in  paediatric intensive care.  
 
96. PROPYLTHIOURACIL  
The following information shall be included in the package insert and product 
literature of products containing propylthiourasil:  
 
WARNINGS NA DPRECAUTIONS  
Potential risk of serious hepatoxicity or liver injury including liver failure and death. 
Patients who are initiated with propylthiourasil should be closely monitored for 
signs and symptoms of liver injury (e.g fatigue, weakness, vague abdominal pain, 
loss of appetide, itching, easy bruising or yellowing of the eyes or skin) especially 
during the first six months. If liver injury is suspected, promptly discontinue 
propylthiourasil therapy.   
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 100Propylthiouracil should not be used in pediatric patients unless the patient is 
allergic to or intolerant of the alternatives available.  
 
97. PSEUDOEPHEDRINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Pseudoephedrine:  
 
WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN 2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
98. PSYCHOTROPIC PRODUCTS  
The following caution statement shall be included conspicously on the labels of all  
psychotropic products : 
CAUT ION:  
This preparation may be habit forming on prolonged use.  
 
99. QUETIAPINE  
The following information shall be included in the package insert and product 
literature of products containing Quetiapine : 
 
WARNINGS : 
 
Hyperglycemia and Diabetes Mellitus  
Hyperglycemia in some cases extreme and associated with ketoacidosis or 
hyperosmolar coma or death, has been reported in patients treated with atypical 
antipsychotics. Assessment of the relationship between atypical antipsychotics 
use and glucose abnormalities is complicated by the possibility of an increased 
background risk of diabetes mellitus in patients with schizophrenia and the 
increasing incidence of diabetes mellitus in the ge neral population. Given this 
confounders, the relationship between atypical antipsychotic use and 
hyperglycemia -related adverse events is not completely understood. However, 
epidemiological studies suggest an increased risk of treatment -emergent 
hyperglyce mia-related events in patients treated with the atypical antipsychotics. 
Precise risk estimates for hyperglycemia -related adverse events in patients 
treated with atypical antipsychotics are not available.  
 
Patients with an established diagnosis of diabetes  mellitus who are started on 
atypical antipsychotics should be monitored regularly for worsening of glucose 
control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 101of diabetes) who are starting treatment with atypical antips ychotics should 
undergo fasting blood glucose testing at the beginning of treatment and 
periodically during treatment. Any patient treated with atypical antipsychotics 
should be monitored for symptoms of hyperglycemia including polydipsia, 
polyuria, polyph agia, and weakness. Patients who develop symptoms of 
hyperglycemia during treatment  with atypical antipsychotics should undergo 
fasting blood glucose testing. In some cases, hyperglycemia has resolved when 
the atypical antipsychotic was discontinued; howev er, some patients required 
continuation of anti -diabetic treatment despite discontinuation of the suspect drug.  
 
100. RISPERIDONE  
The following information shall be included in the package insert and product 
literature of products containing Risperidone : 
 
WARNINGS : 
 
Hyperglycemia and Diabetes Mellitus  
Hyperglycemia in some cases extreme and associated with ketoacidosis or 
hyperosmolar coma or death, has been reported in patients treated with atypical 
antipsychotics. Assessment of the relationship between a typical antipsychotics 
use and glucose abnormalities is complicated by the possibility of an increased 
background risk of diabetes mellitus in patients with schizophrenia and the 
increasing incidence of diabetes mellitus in the general population. Given th is 
confounders, the relationship between atypical antipsychotic use and 
hyperglycemia -related adverse events is not completely understood. However, 
epidemiological studies suggest an increased risk of treatment -emergent 
hyperglycemia -related events in pati ents treated with the atypical antipsychotics. 
Precise risk estimates for hyperglycemia -related adverse events in patients 
treated with atypical antipsychotics are not available.  
 
Patients with an established diagnosis of diabetes mellitus who are started on 
atypical antipsychotics should be monitored regularly for worsening of glucose 
control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history 
of diabetes) who are starting treatment with atypical antipsychotics should 
undergo fa sting blood glucose testing at the beginning of treatment and 
periodically during treatment. Any patient treated with atypical antipsychotics 
should be monitored for symptoms of hyperglycemia including polydipsia, 
polyuria, polyphagia, and weakness. Patien ts who develop symptoms of 
hyperglycemia during treatment  with atypical antipsychotics should undergo 
fasting blood glucose testing. In some cases, hyperglycemia has resolved when 
the atypical antipsychotic was discontinued; however, some patients required 
continuation of anti -diabetic treatment despite disconti nuation of the suspect drug.  
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 102101. SEDA TIVE – HYPNOTIC PRODUCTS  
The following additional information shall be included in the package insert under  
section on ‘Warning’ and ‘Precaution’  of products containing : 
1. Alprazolam  
2. Bromazepam  
3. Clobazam  
4. Diazepam  
5. Flura zepam hydrochloride  
6. Lorazepam  
7. Midazolam  
8. Nitrazepam  
9. Triazolam  
10. Zolpidem tartrate  
11. Zopiclone  
 
WARNING / PRECAUTIONS : 
 
 
 
102. SELENIUM SULPHIDE  
The following warning shall  be included on the labels of products containing  
Selenium sulphide:  
WARNING :  
Do not use on broken skin or inflamed. Avoid contact with eyes.  
(AMARAN: Selenium sulphide tidak boleh digunakan pada kulit yang pecah 
dan radang. Elakkan daripada terkena mata.)  
 
103. SENNA LEAF (CASSIA) dan RHUBARB/RADIX et RHIZOMA RHEI   ANAPHYLAXIS (SEVERE ALLERGIC REACTION) AND 
ANGIOEDEMA  (SEVERE FACIAL SWELLING) WHICH CAN 
OCCUR AS EARLY AS THE  FIRST TIME THE PRODUCT IS TAKEN  
 COMPLEX SLEEP – RELATED BEHAVIORS WHICH MAY 
INCLUDE  SLEEP DRIVING, MAKING PHONE CALLS, PREPARING 
AND EATING  FOOD WHILE WHILE ASLEEP  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 103The following statement shall be included on the labels of products containing  
senna leaf (cassia) and  rhubarb/ radix et rhizoma rhei : 
 Do not use when abdominal pain, nausea or vomiting are present  
 Frequent or prolong use of this preparation may result in dependence 
towards  the product and ‘Imbalanced electrolytes’  
 
104. SODIUM METABISULPHITE  (Excipient)  
The following warning shall be included in the package insert of products  
containing Sod ium metabisulphite:  
WARNING : 
This preparation contains Sodium metabisulphite that may cause serious  
allergic type reactions in certain susceptible patients.  Do not use if known 
to be hypersensitive to bisulphites.  
 
105. SODIUM VALPROATE  
The following boxed  warning shall be included in the package insert under the  
section on “Warning” of products containing Sodium valproate :  
    
106. ST. JOHN’S WORT   
(Hypericum perforatum)  
The following boxed statement shall be included on the labels of products  
containing St. John’s  Wort : 
          
 
107. STATINS  
The following statement shall be included in the package insert of products  
containing statins (Lovastatin, Atorvastatin, Cerivastatin, Fluvastatin, Pravastatin,  
Simvastatin, Somatostatin, Cilastatin etc.)  
Under Drug Interaction : 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 104Concurrent use of fibrates may cause severe myositis and myoglobinuria.  
 
108. SULPHONAMIDES/TRIMETHOPRIM  
The following warning shall be included in the package insert and on the labels of  
products containing Sulphonamides and Trimethoprim  as single ingredient or in  
combination of both ingredients:  
In the package insert : 
                  
 
 
On the labels : 
                  
 
109. TERBUTALINE  
 
The following information shall be included in the package insert and product 
literature of products containing Terbutaline in injection  dosage form : 
 
 As maternal pulmonary oedema and myocardial ischaemia have been 
reported during or following premature labour in patients receiving beta2 – 
agonists, careful attention sho uld be given to fluid balance and cardio -
respiratory function, including ECG monitoring. If signs of pulmonary 
oedema and myocardial ischaemia develop, discontinuation of treatment 
should be considered.  
 
 Due to the risk of pulmonary oedema and myocardial i schaemia that has 
been observed during the use of beta2 -agonists in the treatment of 
premature labour, before these products are given to any patient with 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 105known heart disease, an adequate assessment of the patients’s 
cardiovascular status should be made by  a physician experienced in 
cardiology.  
 
 Cautious use of salbutamol/terbutaline injections is required in pregnant 
patients when it is given for relief of bronchospasm so as to avoid 
interference with uterine contractibility. During IV infusion of 
salbutamol/terbutaline, the maternal pulse should be monitored and not 
normally allowed to exceed a steady rate of 140 beats per minute.  
 
The following information shall be included in the package insert and product 
literature of products containing Terbut aline in oral tablet/ capsule  dosage form : 
 
 As maternal pulmonary oedema and myocardial ischaemia have been 
reported during or following premature labour in patients receiving beta2 – 
agonists, careful attention should be given to fluid balance and cardio -
respiratory function, including ECG monitoring. If signs of pulmonary 
oedema and myocardial ischaemia develop, discontinuation of treatment 
should be considered.  
 
 Due to the risk of pulmonary oedema and myocardial ischaemia that has 
been observed during th e use of beta2 -agonists in the treatment of 
premature labour, before these products are given to any patient with 
known heart disease, an adequate assessment of the patients’s 
cardiovascular status should be made by a physician experienced in 
cardiology.  
 
110. TETRACYCLINE SYRUP  
The product shall not  be indicated for children below  12 years of age.  
The label and the package insert shall incl ude the following boxed warning : 
            
 
 
111. THIORIDAZINE HCl  
The following boxed warning shall be included in  the package insert of products  
containing Thioridazine : 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 106              
 
112. THROMBOLYTIC AGENTS  
The following caution shall be disclosed prominently in the package insert and  
product literature of products containing “systemic thrombolytic agent” in  particular 
“the tissue plasminogen activators” : 
 
WARNING : 
Severe bleeding such as intracranial haemorrhage may occur following  
administration of the drug, particularly in the elderly patients. The risk must  
be balanced against the potential benefit of thrombolysis.  
The following precautions need to be observed:  
Patients should be carefully observed for clinical signs during and  following 
administration of the drug for early detection of bleeding.  Frequent 
haematological tests such as blood coagulation tests are  mandatory.  
To prevent bleeding at the site of centesis or other regions, caution must  be 
exercised concerning procedures and management of arterial/venus  
puncture.  
The use of heparin in conjunction with the thrombolytic agent for the  
purpose of p revention of reocclusion may increase the risk of intracranial  
haemorrhage. Close monitoring of patients is strongly recommended.  
 
113. TIAPROFENIC ACID  
The following precautionary statement shall be included in the package insert of  
products containing Tiaprofenic acid:  
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 107Under Precaution : 
Urinary symptoms (bladder pain, dysuria, and frequency), haematuria or  
cystitis may occur. In certain exceptional cases, the symptoms have  
become severe on continued treatment. Should urinary symptoms occur,  
treatment wi th tiaprofenic acid must be  stopped.  
 
114. TRETINOIN – TOPICAL  
The following statement shall be included in the package insert of products  
containing tretinoin used topically : 
Use in pregnancy:  
          
 
115. TRIAZOLAM  
Please refer to sedative – hypnotic  products  
 
116. TRIPROLIDINE  
The following additional information shall be included in the label and package 
insert of liquid oral products containing Triprolidine:  
WARNING (WHEN USED FOR TREATMENT OF COUGH AND COLD)  
1. NOT TO BE USED IN CHILDREN LESS THAN  2 YEARS OF AGE;  
2. TO BE USED WITH CAUTION AND DOCTOR’S ADVICE IN CHILDREN 2 TO 
6 YEARS OF AGE.  
 
117. SALBUTAMOL  
The following information shall be included in the package insert and product 
literature of products containing Salbutamol in injection  dosage form : 
 
 As maternal pulmonary oedema and myocardial ischaemia have been 
reported during or following premature labour in patients receiving beta2 – 
agonists, careful attention should be given to fluid balance and cardio -
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 108respiratory function, includi ng ECG monitoring. If signs of pulmonary 
oedema and myocardial ischaemia develop, discontinuation of treatment 
should be considered.  
 
 Due to the risk of pulmonary oedema and myocardial ischaemia that has 
been observed during the use of beta2 -agonists in th e treatment of 
premature labour, before these products are given to any patient with 
known heart disease, an adequate assessment of the patients’s 
cardiovascular status should be made by a physician experienced in 
cardiology.  
 
 Cautious use of salbutamol/te rbutaline injections is required in pregnant 
patients when it is given for relief of bronchospasm so as to avoid 
interference with uterine contractibility. During IV infusion of 
salbutamol/terbutaline, the maternal pulse should be monitored and not 
normall y allowed to exceed a steady rate of 140 beats per minute.  
 
The following information shall be included in the package insert and product 
literature of products containing Salbutamol in oral tablet/ capsule  dosage form : 
 
 As maternal pulmonary oedema and myocardial ischaemia have been 
reported during or following premature labour in patients receiving beta2 – 
agonists, careful attention should be given to fluid balance and cardio -
respiratory function, including ECG monitoring. If signs of pulmonary 
oedema and myocardial ischaemia develop, discontinuation of treatment 
should be considered.  
 
 Due to the risk of pulmonary oedema and myocardial ischaemia that has 
been observed during the use of beta2 -agonists in the treatment of 
premature labour, before these pr oducts are given to any patient with 
known heart disease, an adequate assessment of the patients’s 
cardiovascular status should be made by a physician experienced in 
cardiology.  
 
118. VITAMIN K1 (PHYTOMENADIONE)  
The following statement shall be included in  the package insert of products  
containing Vitamin K1 (phytomenadione) as single ingredient used intravenously:  
WARNING : 
Severe reactions, including fatalities, have occurred during and  immediately 
after intravenous injection of Vitamin K1. Restrict intrav enous  use to 
emergency case. When intravenous administration is necessary, the  rate of 
injection should not exceed 1mg per minute . 
Administration :  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 109In severe bleeding, or situations where other routes are not feasible, Vitamin K1  
may be given by very slow intravenous injection, at a rate not exceeding 1mg per  
minute.  
 
119. WARFARIN  
The following statement shall be included in the package insert of products  
containing Warfarin : 
Under Caution : 
Topical preparations containing methyl salicylate should be used w ith care in  
patients on Warfarin and excessive usage is to be avoided as potentially  
dangerous drug interaction can occur.  
 
120. ZIPRASIDONE  
The following information shall be included in the package insert and product 
literature of products containing Ziprasidone : 
 
WARNING S: 
 
Hyperglycemia and Diabetes Mellitus  
Hyperglycemia in some cases extreme and associated with ketoacidosis or 
hyperosmolar coma or death, has been reported in patients treated with atypical 
antipsychotics. Assessment of the relation ship between atypical antipsychotics 
use and glucose abnormalities is complicated by the possibility of an increased 
background risk of diabetes mellitus in patients with schizophrenia and the 
increasing incidence of diabetes mellitus in the general popula tion. Given this 
confounders, the relationship between atypical antipsychotic use and 
hyperglycemia -related adverse events is not completely understood. However, 
epidemiological studies suggest an increased risk of treatment -emergent 
hyperglycemia -related events in patients treated with the atypical antipsychotics. 
Precise risk estimates for hyperglycemia -related adverse events in patients 
treated with atypical antipsychotics are not available.  
 
Patients with an established diagnosis of diabetes mellitus wh o are started on 
atypical antipsychotics should be monitored regularly for worsening of glucose 
control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history 
of diabetes) who are starting treatment with atypical antipsychotics sho uld 
undergo fasting blood glucose testing at the beginning of treatment and 
periodically during treatment. Any patient treated with atypical antipsychotics 
should be monitored for symptoms of hyperglycemia including polydipsia, 
polyuria, polyphagia, and we akness. Patients who develop symptoms of 
hyperglycemia during treatment  with atypical antipsychotics should undergo 
fasting blood glucose testing. In some cases, hyperglycemia has resolved when 
the atypical antipsychotic was discontinued; however, some pat ients required 
continuation of anti -diabetic treatment despite discontinuation of the suspect drug.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 110 
121. ZOLPIDEM TARTRATE  
Please refer to sedative – hypnotic products  
 
122. ZOPICLONE  
Please refer to sedative – hypnotic products   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 111Appendix 4: Types of variations and supporting documentation required  
 
GUIDELINES ON APPLICATION FOR VARIATION OF REGISTERED PRODUCTS  
 
The purpose of this guideline  is to provide guidance to marketing authorization holders (MAH)/applicants who intend to  apply 
to vary the registered information of a registered product. The gui deline defines the type of variations and outlines  the 
supporting documents necessary for each type of variation:  
 
Type I: Minor variation with a 14 days validation period  
The marketing authorization holder may proceed to implement the change after a 14 da ys validation period upon  the 
date of receiving the documents by variation unit.  
Minor variations are subject to the conditions specified.  
FOR INTERIM PERIOD : 
An applicant may submit Type I variation manually together with the required documents by using the form  
specified. The manual submission must be submitted together with variation online application. The a pproval will  
only be notified via online submission.  
 
Type II: Major Variation  
Type II variation is considered a major change and approval is required prior to implementation.  
The Marketing Authorization Holder is responsible for ensuring that all the necessary validation has  been conducted to  
demonstrate that the change does not reduce the quality, safety or efficacy of the product.  
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 112ATTACHME NT 1  
TYPE I  
 
 
 
No.  
 
TITLE OF 
VARIATION   
AFFECTED FIELDS   
 
SUPPORTING DOCUMENTS REQUIRED  
OR CONDITIONS TO BE FULFILLED  
  
PHARMACEUTICAL   
ABRIDGED   
TRADITIONAL  
 
1.  
Change in name of 
manufacturer and/or 
repacker without any 
change in address of site.   
Can be made through  
 
VIEW & EDIT  
VALIDATION   
 Can be made through  
 
VIEW & EDIT 
VALIDATION   
Can be made through  
 
VIEW & EDIT 
VALIDATION   
a) Certificate of name change i.e. Form 13 
Company Act 1965.    
 
please attach the supporting document at 
E12/F12 . 
 
 
2.  
Change in 
company logo on 
the packaging 
components 
(without any 
changes on 
graphic or label 
content)  
  
D1, D2, D3  
  
D1, D2, D3  
  
D1, D2, D3  
  
a) Draft packaging components with the 
amended information.  
 
3.  
Change in product owner   
E1.1, E1.2, E2.1, E2.2, E12  
D1, D2, D3   
E1 
F1, F2.1, F2.2  
D1, D2, D3   
E1  
F1, F2.1, F2.2, F12  
D1, D2, D3  
   
Condition:  
a) The Marketing Authorization Holder 
remains the same  
b) The manufacturing site remains the 
same.  
 
Documentations:  
a) Letter of confirmation for change in 
product owner sign by both old and  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 113new product owner [E12 / F12]  
b) Letter of Authorization from new 
product owner to the existing 
Merketing Authorization Holder 
[E1.2 / F1]  
c) In the case of a contract 
manufacturer, new prod uct owner 
to issue Leteer Of Appointment to 
contract manufacturer [F2.1, E2.1] 
and contract manufacturer to issue 
Letter Of Acceptance [ F2.2, E 2.2]  
d) Revised labels and package insert 
(if aookicable) [D1, D2, D3]  
 
4.  
Change in importer or 
distributor   
E13.1   
E2.1 
 
 
 
 
 
 
 
  
E2.1 
  
 
 
 
 
 
 
 
5. Replacement, or 
addition of 
imprints, bossing 
or other markings 
(except 
scoring/break 
lines) on tablets 
or printing on 
capsules, 
including 
replacement, or 
addition of inks 
used for product 
marking.  A4,  
P1, P5.1, P5.2 ,  
D3, E8(if applicable )  
A2, 
D3,  
F8  
A2,  
D3 ,  
F8 (if any)   
a) Finished product release and shelf life 
specification have not been changed 
except for the description  
b) Any new ink must comply with the 
relevant pharmaceutical legislation.  
- New description of the product.  
 
 
 
6.  
Change in shape 
or dimensions of 
the container or 
closure.  
  
P7    
a) No change in the type of container or 
closure.  
b) The product is not intended to be 
sterile.  
c) No change is made to the product shelf  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 114life and/or storage conditions.  
 
7.  
Change in pack size of 
the finished product.  
- Change in the 
number or units (e.g. 
tablets, ampoules) in 
a pack.  
- Change in volume of 
non sterile 
preparations  
- Change in volume of 
parenteral 
preparations and 
peritoneal dialysis 
with similar  
characteristics.   
C1,  
D3, E8(if applicable)   
C1,  
D3,  
E8  
C1,  
D3,  
E8  
a) The primary packaging materials 
remains the same.  
 
 
 
8.  
Tightening of 
specification limits of 
finished product or active 
ingredient.   
E9,E10  
P5.1, P5.2,P 5.4  
S4.1, S4.2,S 4.4   
B4, 
F10 ( finished product) ,  
F11 (active ingredient)  
 
  
B4,  
F10 ( finished 
product)  
F11 (active 
ingredient)   
a) New specifications  
b) Certificate of analysis (CoA) FPQC 
(P5.4) or active ingredient X 1 batch 
(S4.4)  
 
9.  
Change in source or 
addition of source of 
active ingredient without 
any change in 
specification  (except 
direct compressed 
granules/ pellets).   
S2.1  
NOT APPLICABLE   
NOT APPLICABLE  
  
a) Finished product release and end of 
shelf life specification remains the 
same.  
  
 
 
 
 
 
10.  
Change in secondary 
packaging material    
C2,  
D1, D2, D3  
P7  
C2,  
D1,D2,D3  
 
  
C2 
D1,D2,D3  
  
a)    The primary packaging material  
remains the  same.  
b) Draft packaging components.  
 
 
11.  
Change in test procedure 
or analytical protocols of 
finished product.  
  
E9, E10   
B4,  
F9  
  
B4,  
F9  
a) Appropriate (re -)validation studies have 
been performed in accordance with 
relevant guidelines.  
b) Results of method validation show new  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 115test procedure to be at least equivalent 
to the former procedure.  
c) Finished product specifications are not 
adversely affected.  
 
12.  
Change in name and/or 
address of a manufacturer 
of the active substance   
S2.1  
NOT APPLICABLE   
NOT APPLICABLE  
  
 
 
13.  
Change in testing 
procedure of an excipient   
P4.2, P4.3     
Specifications of the excipient/finished 
product remain the same.  
 
 
 
TYPE II  
1.  
Change in product name 
only.  
Can be made through  
 
VIEW & EDIT VALDATION  
  
Can be made through  
 
VIEW & EDIT 
VALIDATION  
  
Can be made through  
 
VIEW & EDIT 
VALIDATION  
  
a) Draft  label and leaflet.  
a) Letter confirming change in name only 
issued by the MAH or manufacturer.   
 
2.  
Change in content of 
leaflet or prescribing 
information/PIL/SPC.   
A1 – A17, C1  
D3,  
E7 (Summary of Product 
Characteristics from 
manufacturer)  
E8 (if applicable)   
A1 – A13, C1  
D3, F7, F8   
PIL/SPC is not 
compulsory for 
traditional product  
 
A1 – A14,  
D3, F7, F8   
a) For all types of product provide: - 
- Copy with amendments clearly marked.   
- Clean copy of the proposed new leaflet.  
 
 please note that only clean  copy of package 
insert is to be attached at D3 in addition to 
the supporting documents.  
  
 
b) Provide the following (innovator product 
only): - 
- Company Core Datasheet  
- Conclusion or abstract of recent 
Periodic Safety Update Report where 
relevant.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 116- Expert Clinic al Report (if applicable)  
For generic product please provide a copy of 
reference to support the change   
 
  
3.  
Change in content of label 
inclusive of change in 
graphics.  
  
D1, D2  
  
D1, D2  
  
D1, D2  
  
a) Draft label with changes marked clearly.  
  
b) Clean copy of label  
 
4.  
Change in manufacturing 
process of the finished 
product    
E11,  
P 3.2, P3.2.1, P3.3, P3.4, 
P5.1, P 5.4, P8   
B 2.1, B 2.2, B3, B4, 
B5, 
F10 (CoA of finished 
product)  
 
  
  
B 2.1, B 2.2, B3, B4, 
B5, 
F10  
a) Finished product specification is not 
adversely affected.  
b) The new process must lead to an 
identical product regarding all aspect of 
quality, safety and efficacy.  
c) The product does not contain a 
biological active substance.  
 
 Certificate of analysis (CoA) 
FPQC (P5.4)  
- Requirement :  
2 batches for imported products  
1 batch for locally manufactured 
products  
 
5.  
Change in overage of 
active ingredient or 
excipient   
B1.1, B1.2   
B1.1,B1.2  
 
  
B1.1,B1.2   
Finished product release and end of shelf life 
specification remains the same   
 
6.  
Replacement of an 
excipient with a 
comparable excipient 
and/or change in content 
of excipient.  
   
Can be made through  
 
VIEW & EDIT  
VALIDATION  
  
Can be made through  
 
VIEW & EDIT 
VALIDATION  
 
  
Can be made through  
 
VIEW & EDIT 
VALIDATION  
  
a) No changes on the specification of the 
excipient for product specific 
requirements (e.g. particle size profiles, 
polymorphic form, etc.), if applicable.  
 
b) Any new excipient does not include the 
use of materials of human or animal 
origin for which assessment is required 
of viral safety data.  
 
c) Provide the following: -  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1171. Comparison of new and existing 
formula  
2. Batch Manufacturing Formula  
3. Excipient specification  
4. Manufacturing process  
5. Stability data of finished product 
(refer to Malaysian  Guidelines for 
Stability Studies of Drug Product 
for data required) -} new formula  
6. to amend label ( If applicable, i.e. if 
the   
      variations involve the addition of   
      preservative /alcohol) (D1 & D2)  
 
7. Certificate of analysis (CoA) FPQC 
X 1   
      batch (P5.4) } of the new formula  
 
7.  
Change in batch size.   
B 1.1, B1.2   
B 1.1, B1.2  
 
 
  
B 1.1, B1.2   
a) The change does not affect the 
reproducibility and/or consistency of the 
product.  
b) No change to the manufacturing 
method nor to the in -process controls 
other that those necessitated by the 
change in batch -size, e.g. use of 
different size equipment.  
c) Finished product specification is not 
adversely affected.  
d) To provide Batch manufacturing formula  
e) batch comparative analysis  
---imported product/s :  
         3 batch for each old and new   
         batch size  
      ---locally manufactured product/s:  
          3 batch for old and 1 new batch  
 
8.  
Change in capsule shell or 
film coated agent.  
  
Can be made through  
 
VIEW & EDIT VALIDATION  
 
  
Can be made through  
 
VIEW & EDIT 
VALIDATION  
  
Can be made through  
 
VIEW & EDIT 
VALIDATION  
  
a) Includes change of hard gelatin capsule 
to vegetable capsule but does not apply 
change from hard gelatin capsule to soft 
gel capsule.  
b) Provide the following : -  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 118  - New unit formula for coating agent  
- Batch manufacturing formula  
- New manufacturing process  
c)   Stability data of finished product (refer  
to Malaysian Guidelines for Stability 
Studies of  Drug Product for data 
required)  
d) to include the function for each and every excipient  
used.  
9.  
Change in finished 
product or active 
ingredient specification    
E9, E10,  
P5.1,  
S4.1  
B4,  
F10  
B4 
F10  
a) Includes addition of a new test 
parameter.  
b) Certificate of analysis for one batch ( for 
locally manufactured product/s) or two 
batches (for imported product/s) as  per 
the new specification to be provided 
upon approval and when change is 
affected.  
 
10.  
Change to in -process 
tests or limits applied 
during manufacture of the 
product.   
P3.3  
B3  
B3 a) Includes tightening of in -process limits 
and addition of new tests  
b) Any change should be within the range 
of the currently approved limits.  
11.  
Change/ addition in 
primary packaging 
material.   
C2,  
D1, D2, D3  
P3.2, P8  
  
C2  
D1, D2. D3  
B5  
C2  
D1, D2. D3  
B5  
a) Provide the following: - 
- Assembly process for the new 
packaging material  
- stability data (refer to Malaysian Guidelines for 
Stability Studies of Drug Product for data required)  
- Draft label  
 
12.  
Change in shelf life of 
finished product: - 
 As packaged for sale  
 After first opening  
 After reconstitution   
A15, 
A16, P8  
 
D1,D2, D3 
 
  
A13,  
B5 
 
D1,D2, D3  
  
A13, 
B5 
 
D1,D2, D3  
  
a) Provide stability data (refer to Malaysian 
Guidelines for Stability Studies of Drug 
Product for data required)  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 11913.  
Change in storage 
conditions  
  
A14, 
A15, P8  
 
D1,D2, D3   
A12  
B5 
 
D1,D2, D3   
A12, 
B5 
 
D1,D2, D3 
  
a) Provide stability data (refer to Malaysian 
Guidelines for Stability Studies of Drug 
Product for data required)  
14.  
Appointment or 
change in 
repacker.   
D1, D2, D3 ,  
E14, 
*E12 (for other  
       supportive documents)  
 
  
E3  
D1, D2, D3 ,  
*F12 
 
  
E3, 
D1, D2, D3 ,  
*F12 
  
a) Provide the following: - 
- *GMP certificate of the new packer  
- *Assembling process  
- *Letter of appointment and 
acceptance for contract repacker   
- Draft label  
 
 
 
 
 
 
 
NOTE:  
1. Other supportive documents can be attached at E12 (or F12) where such documents are necessary.  
2. Please note that for every variations made, reason for changing/remarks should be clearly written an d 
explained.  
3. Please note that there will be no correspondence with the applicant for variation module. For any re jection 
made for  certain field, only the main field will be rejected (i.e. the supportive documents will be kept until  the 
main field is  resubmitted). However, if the main field is not resubmitted without any reason for a certain period 
of time, the supportive  documents wil l be rejected and a new application must be submitted.  
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 120 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 121Appendix 5: Supporting Docum entation required for Change in Manufacturing Site 
Application  
 
No Document to be submitted  Type  
II Type  
III Type  
IV Type  
 V 
1.  Letter of authorization/appointment from the 
manufacturer/product owner  
  
√  
√  
√  
√ 
2.  Letter from the manufacturer/product owner to 
clarify/explain the need to change site of 
manufacture  
  
√  
√  
√  
√ 
3.  Written declaration from the manufacturer to 
certify that the manufacturing process, and the 
release and expiry (check) specifications of the 
product as the same as already approved  
 OR 
If there are minor changes, to declare the ‘minor 
changes’ & justify the need for such changes.  
  
√  
√  
√  
√ 
4.  ‘Release’ and ‘end -of-life’ specifications as 
approved by the DCA  
  
√  
√  
√  
√ 
5.  Original copy of the Certificate of Free Sale and 
Good Manufacturing Practice/ Certificate of 
Pharmaceutical Product from the source country 
of the new manufacturing site in the case of an 
imported product or confirmation of GMP status 
(according to Guideline) for a locally 
manufactured product.  
  
√  
√  
√  
√ 
6.  Original copy of Certificate of Analysis for 1 batch 
of product from the new manufacturing site  
  
√  
√  
√  
7.   “Accelerated” stability data for at least 3 months  
for 1 batch of product manufactured at the new 
site. (3 months at 45 -50ºC and RH 75%, 6 
months at 40ºC and RH 75%)  
  
√  
√  
√  
8.  Amended immediate label, outer label and 
package insert for the product from the new site  
 
 
  
√  
√  
√  
√ 
9.  Process Validation Report for the new site for 3 
batches ( pilot or commercial scale)  
OR   
√  
√   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 122Process Validation Report for the pilot scale 
together with a confirmation from the 
manufacturer that complete process validation 
will be carried out on 3 following consecutive 
batches  
OR  
Retrospective Validation Report (Refer Guideline)  
 
10.  Commitment to submit long term stability data  
  
√  
√  
√ 
  
 
11.  Commitment to submit stability data, certificate of 
analysis and sample for laboratory testing within 
6 months of approval of site change  
     
√ 
12.  A written plan for assessing the effect of the 
change of site on the quality of the product with 
the objective of demonstrating that the pre - and 
post-change products are equivalent.  
  
√   
√  
13.  Report of bioavailability and bioequivalence 
studies for generic products and dissolution 
profile for innovator products (refer to ASEAN 
Guidelines and list of products requiring BA and 
BE study)   
√  
√  
√  
√ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 123CHANGE OF MANUFACTURING SITE WITHIN MALAYSIA  
 
TYPE I is change in the location of the site of manufacturing within  Malaysia only. 
This change maybe due to upgrading of facilities, and/or expansion of manufacturing 
activities or moving to a newly constructed  plant. The equipment, standard operating 
procedure (SOP’s),  environmental condit ions (e.g. temperature and humidity) and 
controls  remain the same. Approval from NPCB is required prior to implementation  
of the change.  
 
Documentation to be supplied:  
1. GMP inspection report for newly constructed (pre -license) or  refurbished 
facilities or G MP manufacturing license (existing  premise) certifying that the 
facility complies with GMP  requirements  
2. Declaration in writing that the formulation, manufacturing  process and 
specifications are the same as already  approved  
3. Copy of approved release and end of shelf life specification  
4. Declaration and commitment that the manufacturer will carry  out continuous 
quality monitoring on the post change  products  
5. A written plan for assessing the effect of the change of site  on the quality of 
the product with the objec tive of  demonstrating that the pre and post change 
products are  equivalent. The plan must include a commitment for one  batch 
of product manufactured at the new site to be on long  term stability 
monitoring.  
6. Long term stability data for one b atch on completi on of the study  
7. Revised drafts of the package insert  and labelling where applicable  
8. Report of bioavailability and bioequivalence studies for generic products and 
dissolution profile for innovator products (refer to ASEAN Guidelines and list 
of products req uiring BA and BE study)  
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 124Appendix 6 : List of ingredients (active) not allowed to be registered by the  Drug 
Control Authority  
 
SPECIFIC INGREDIENTS  
1. ACETIC ACID (expectorant)  
2. ARISTOLOCHIC ACID  
3. ALLANTOIN (eye drop)  
4. ALLERGEN EXTRACTS (vaccines, diagnostics)  
5. AMINOPYRINE/ AMIDOPYRINE  
6. AMPHETAMINE (in cough mixtures, appetite suppressants)  
7. ANIMAL ORGAN  (excluding Traditional Products)  
8. ANTIHISTAMINE (for topical use)  
9. ASTEMIZOLE  
10. BACILLUS COAGULANS  
11. BERBERINE  
12. BISMUTH SALTS except Bismuth subcitrate (in oral preparations)  
13. BORIC ACID / BORAX [in oral, topical (skin), vaginal, nasal dosage form ] 
14. BUTOBARBITONE  
15. CAFFEINE  
16. CAMPHOR:  - oral  
- external (more than 11%)  
17. CHLORMEZANONE  
18. CHLOROFORM (as expectorant)  
19. CISAPRIDE  
20. CODEINE (cough syrup)  
21. COCILLANA LIQ. EXTRACT (expectorant)  
22. CONJUGATED LINOLEIC ACID  
23. CRINIS CARBONISATUS  
24. CYPROHEPTADINE (as appetite stimulant)  
25. DANTHRON  
26. DIHYDROSTREPTOMYCIN (in oral antidiarrhoeals)  
27. DIPHENOXYLATE (as liquid oral dosage for anti -diarrhoeal)  
28. DIPYRONE   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 12529. QUINESTROL (as lactation suppressant ) 
30. ENTEROCOCCUS FAECALIS  
31. ENTEROCOCCUS FAECIUM  
32. ETHENZAMIDE  
33. ETHYNODIOL DIACETATE (in oral contraceptives)  
34. EUFLAVINE  
35. EUPHORBIA LIQ. EXTRACT (expectorant)  
36. FURAZOLIDONE  
37. FENFLURAMINE/ DEXFENFLURAMINE  
38. GAMMA -BUTYROLACTONE (GBL)  
39. GAMMA -HYDROXYBUTYRIC ACID (GBH)  
40. GATIFLOXACIN  
41. GENTIAN VIOLET  
42. GERMANIUM (except naturally occurring)  
43. HALOQUINOL  
44. HEXACHLOROPHENE  
45. HYDROQUINONE (oral)  
46. LACTOBACILLUS ACIDOPHILLUS (antidiarrhoeal)  
47. LOPERAMIDE (as liquid oral dosage for anti -diarrhoeal)  
48. LYNOOESTRENOL (in oral contraceptives)  
49. L-TRYPTOPHAN (EXCEPT parenteral nutrition products and enteral feeding  
products)  
50. MAGNESIUM ASCORBRYL PHOSPHATE (as antipigmentation)  
51. MERCUROCHROME  
52. MESTRANOL (in oral contraceptives)  
53. METHYLENE BLUE (in oral preparations)  
54. MORPHINE (in cough mixtures)  
55. NEOMYCIN (i n oral antidiarrhoeal, vaginal tablets, topical powders, aerosols,  
nasal preparations)  
56. NIMESULIDE  
57. NORADRENALINE (in dental preparations)  
58. NORGESTREL (in oral contraceptives)  
59. NOVOBIOCIN  
60. OXYPHENISATIN ACETATE / ACETOPHENOLISATIN   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 12661. OXYPHENBUTAZONE  
62. PARACETAMOL (liquid oral 500 mg/5 ml)  
63. PERGOLIDE  
64. PENICILLIN (for topical use)  
65. PHENAZOPYRIDINE (in urinary analgesics)  
66. PHENACETIN  
67. PHENAZONE / ANTIPYRINE  
- PROPYLPHENAZONE  
- ISOPROPYLPHENAZONE  
68. PHENOLPHTHALEIN (stimulant purgative)  
69. PHENYLBUTAZONE  
70. PHENYLPROPALAMINE  
71. PIPERAZINE  
72. PIZOTIFEN (as appetite suppressant)  
73. PODOPHYLLUM RESIN (in oral preparations)  
74. PRENYLAMINE  
75. QUINALBARBITONE  
76. SALICYLAMIDE  
77. STANOZOLOL  
78. SULPHAGUANIDINE  
79. SULPHONAMIDES (for topical use)  
80. SQUILL (expectorant)  
81. TEGASEROD  
82. TERFENADINE  
83. TERPENE HYDRATE (expectorant)  
 
COMBINATION PRODUCTS  
1. Combinations containing any ingredients listed in A  
2. Combinations with any BARBITURATES  
3. Combinations of VITAMIN (S) with other drugs:  
a. VITAMIN (S) + APPETITE SUPPRESSANT  
b. VITAMIN (S) + CORTICOSTEROID  
c. VITAMIN (S) + ANALGESIC   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 127d. VITAMIN (S) + LAXATIVE  
e. VITAMIN (S) + SLIMMING AGENTS  
4. AMPICILLIN + CLOXACILLIN  
5. ANTIBIOTICS + PAPAIN / PROLASE  
6. CORTICOSTEROIDS + ANTIHISTAMINES  
7. PROPANOLOL + HYDRALAZINE  
8. PROPANOLOL + SPIRONOLACTONE  
9. COUGH, COLD AND ALLERGY Products containing:  
a. Four or more pharmacological g roups in one product.  
b. Two or more drugs from the same pharmacological group  
c. ANTYPYRETIC -ANALGESIC + EXPECTORANT  
d. ANTICHOLINERGIC + BRONCHODILATOR  
e. ANTIMONY POTASSIUM TARTRATE (as expectorant)  
f. ALLYLISOTHIOCYANATE / MUSTARD OIL (as nasal  decongestant)  
g. CHLOROFO RM (as expectorant)  
h. CODEINE + EPHEDRINE / PSEUDOEPHEDRINE  
i. METHAPYRILENE  
j. PARACETAMOL + MUCOLYTIC / EXPECTORANT  
k. TURPENTINE OIL (AS EXPECTORANT / ANTITUSSIVE)  
10. Combinations containing DEXTROPROPOXYPHENE  
11. Combinations containing SPIRONOLACTONE  
12. Combinations of two or more ANALGESIC with same mode of action  
13. ANTACID + CHARCOAL  
14. GRIPE WATER containing ALCOHOL  
15. Combinations containing VITAMIN K (in oral preparations)  
16. EYE DROPS containing VITAMIN  
17. Combinations containing ANIMAL ORGAN  
18. Combinations containing antacid and surface local anaesthetic agent.  
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 128Appendix 7: List of ingredients (excipient) banned / allowed only to  specified limits  
 
1. COLOURING AGENTS (including for capsule shells)  
- AMARANTH  
- TARTRAZINE in oral, rectal, vaginal or nasal preparations  
- RED 2G in oral preparations and preparations used for mucosa 
membrane  
 
2. SWEETENERS / FLAVOURING AGENT  
- CYCLAMATES  
- MENTHOL ( LIMITED TO 10MG/DAY ) 
- SACCHARIN AND SALTS (LIMITED TO 5MG/KG/DAY ) 
 
3. PRESERVATIVES  
- CHLOROFORM  (LIMITED TO NOT MORE THAN 0.5% in 
pharmaceuticals for inter nal use ) 
- THIOMERSAL in preparations for the eye 
 
For other preparations, allowed only if the following information is 
included in the package insert and product literature of products 
containing thiomersal:  
 
WARNING:  
‘RISK OF SENSITIZATION IN RELATION TO THIOMERSAL AND 
OTHER PRESERVATIVES’  
 
4. OTHERS  
- METHYLENE CHLORIDE as solvent in film-coating; for locally 
manufactured  products only (to protect the workers)  
- ALCOHOL (allowed only if essential to the formulation and no 
suitable  alternative to alcohol are avai lable. Content of alcohol 
should be the  minimum necessary. ) 
- CHOLOROFLUOROCARBONS (CFC)  
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 129Appendix 8: Permitted colouring agents in pharmaceutical and traditional  products  
 
 
NO. COLOURANT  
1.  Allura Red AC  
 
2.  Anthocyanins  
a. Those glycosides of 2-phenylbenzopyrylium salts which are 
anthocyanins  
b. The following anthocyanidin aglycones :  
- Pelargonidin  
- Cyanidin  
- Peonidin  
- Delphinidin  
- Petunidin  
- Malvidin  
 
3.  Beetroot Red, Betanin (Aqueous extracts)  
 
4.  Black PN (Brilliant Black BN)  
 
5.  Brilliant Blue FCF  
6.  Calcium Carbonate  
7.  Carbo medicinals/vegetalis; (charcoal)  
8.  Caramel  
9.  Carmoisine (or Azorubine)  
10.  Carotenoids  
a. Alpha, Beta, Gamma -Carotene  
b. Bixin, Noribixin, Roucou, Annatto  
c. Capsanthin, Capsorubin, (paprika extract)  
d. Lycopene  
e. Beta-Apo-8’ carotenal (C 30)  
f. Ethyl ester of Beta -Apo-8 Carotenoic Acid (C30).  
i. Chlorophyll  
ii. Copper complexes of Chlorophyll and Chlorophyllins  
 
11.  Chocolate Brown HT  
12.  Cochineal or Carminic acid, Carmine from Cochineal  
 
13.  Curcumin   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 13014.  Fast Green FCF (FD & C Green No.3)  
15.  Green S (Acid Brilliant Green BS, Lissamine Green)  
 
16.  Indigo Carmine (Indigotine)  
17.  Lactoflavin, Riboflavin  
18.  Orange Yellow S (Sunset Yellow FCF)  
 
19.  Patent Blue V  
20.  Ponceau 4R (Cochineal Red A)  
 
21.  Quinoline Yellow  
22.  Xanthophylls  
a. Flavoxanthin  
b. Lutein  
c. Cryptoxanthin  (Kryptoxanthin)  
d. Violoxanthin  
e. Rhodoxanthin  
f. Canthaxanthin  
 
23.  The following colouring matters natural to edible fruits or vegetables : - 
Alkannin  
Annatto (including eye)  
Carotene (including eye)  
Chlorophyll  
Flavine  
Indigo  
Osage  
Orange  
Persian Berry  
Saf flower  
Saffron  
Sandalwood  
Tumeric  
or their pure colouring principles whether isolated from such natural 
colours or produced synthetically  
 
24.  Bole or Iron oxide, Carbon Black (or vegetable origin), Titanium dioxide  
 
25.  The Aluminium salts (lakes) of any of the sch eduled synthetic dyes  
approved for use,                                                                                                            
(a) Alumina (Dried Aluminium Hydroxide)  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 13126.  Dihydroxyacetone (external use with specific drugs only ) 
 
27.  Bismuth Oxychloride (external use only, including eye)  
 
28.  Ferric Ammonium Ferrocyanide (external use only, including eye)  
 
29.  Ferric Ferrocyanide (external eye only)  
30.  Chromium Hydroxide Green (external use only)  
 
31.  Chromium Oxide Green (external use only, including eye)  
 
32.  Guanine (external use only)  
33.  Prophyllite (external use only)  
34.  Mica (external use only, including eye)  
35.  Talc 
36.  Bronze (external use only, including eye)  
37.  Copper (external use only, including eye)  
38.  Zinc Oxide (external use only, including eye)  
39.  FD & Blue No. 2  
40.  D & C Blue No. 4  
41.  D & C Green  No. 5  
42.  D & C Green No. 6 (external use only)  
43.  D & C Green No. 8 (external use only)  
44.  D & C Orange No. 4 (external use only)  
45.  D & C Orange No. 5 (mouth wash, dentifrices, external use only)  
 
46.  D & C Orange No. 10 (external use only)  
47.  D & C Orange No. 11 (external use only)  
 
48.  FD & C Red No. 4 (external use only)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 13249.  D & C Red No. 6 – may be use in combination;  
                                  total not more than 5mg/day  
 
50.  D & C Red No.  7 – may be used in combination;  
                                  total not more than 5mg/day  
 
51.  D & C Red No. 17  
52.  D & C Red No. 21  
53.  D & C Red No. 22  
54.  D & C Red No. 27  
55.  D & C Red No. 28  
 
56.  D & C Red No. 30  
57.  D & C Red No. 31 (external use only)  
58.  D & C Red No. 34 (external use only)  
59.  D & C Red No. 39 (external use only, not more than 0.1%)  
 
60.  D & C Yellow No. 7 (external use only)  
61.  Ext. D & C Yellow  No. 7 (external use only)  
62.  D & C Yellow No. 8 (external use only)  
63.  D & C Yellow No. 11 (external use only)  
64.  Tartrazine/FD & C Yellow No. 5/MA Yellow A -2/Aluminic lake (external 
use only)  
65.  Erythrosine/FD & C Red No. 3  
66.  Yellow 2G (food yellow)  
67. D & C Yellow No. 6  
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 133Appendix 9 : Guidance notes for Health Supplement  Products  
 
9.1 Health Supplements  
 
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.  
 
Dietary supplements may include ingredients such as:  
o Vitamins, minerals, amino acids  
o Natural substances of plant/animal origin  
o Enzymes, substances with nutritional/physiological function  
 
9.2 Indication  
 
Used as Health Supplement  
Used as Dietary Supplement  
Used as  Food Supplement  
Used as Nutritional Supplement  
 
Vitamins and mineral supplements for pregnant and lactating women.  
 
9.3 Route of Administration  
 
Oral 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1349.4 Activ e Ingredients in Health Supplement  
 
List A : List of Active ingredients  
 
1. Alpha carotene  
2. Alpha lipoic acid  
3. Amino acid chelate  
4. Arabinogalactan  
5. Ascorbic acid  
6. Ascorbyl palmitate  
7. Betacarotene  
8. Betaine  
9. Bifidobacterium 
animalis  
10. Bifidobacterium 
bifidum  
11. Bifidobacterium 
infantis  
12. Bifidobacterium 
lactis  
13. Bifidobacterium 
longum  
14. Bioflavonoids  
15. Biotin  
16. Boron aspartate  
17. Boron citrate  
18. Boron gluconate  
19. Bromelain  
20. Calcium ascorbate  
21. Calcium carbonate  
22. Calcium caseinate  
23. Calcium citrate  
24. Calcium gluconate  
25. Calcium 
glycerophosphate  
26. Calcium hydrogen 
phosphate  
27. Calcium lactate 
gluconate  
28. Calcium lactate 
pentahydrate  
29. Calcium malate  
30. Calcium pantothenate  31. Calcium phosphate  
32. Chitosan  
33. Choline bitartrate  
34. Chondroitin sulphate 
sodium  
35. Chromium chloride  
36. Chromium nicotinate  
37. Chromium picolinate  
38. Citrus bioflavonoids  
39. Citrus sinensis  
40. Cod liver oil  
41. Coenzyme Q10  
42. Colecalciferol  
43. Collagen  
44. Copper gluconate  
45. Copper glycinate  
46. Cupric oxide  
47. Cupric sulphate 
pentahydrate  
48. Cyanocobalamin  
49. Cysteine  
50. Cysteine 
hydrochloride  
51. Dolomite  
52. Enzyme Amylase  
53. Enzyme Lactase  
54. Enzyme Protease  
55. Enzyme Papain  
56. Enzyme Lipase  
57. Enzyme Cellulase  
58. Ergocalciferol  
59. Ferrous fumarate  
60. Ferrous gluconate  
61. Fish oil  
62. Folic acid  
63. Fructooligosaccharide  
64. Glutamic acid 
hydrochloride  
65. Glutamine  
 66. Glycine  
67. Glycine max  
68. Hesperidin  
69. Inositol  
70. Inulin  
71. Isoflavone  
72. Lactobacillus 
acidophilus  
73. Lactobacillus bifidus  
74. Lactobacillus 
bulgaricus  
75. Lactobacillus casei  
76. Lactobacillus 
delbrueckii ssp. 
Bulgaricus  
77. Lactobacillus gasseri  
78. Lactobacillus lactis  
79. Lactobacillus 
paracasei spp. 
Paracasei  
80. Lactobacillus 
plantarum  
81. Lactobacillus reuteri  
82. Lactobacillus 
rhamnosus  
83. L-Arginine  
84. L-Carnitine  
85. L-Carnitine HCL  
86. L-Cysteine HCL  
87. L-Glutamine  
88. L-Glutathione  
89. L-Glycine  
90. L-Isoleucin  
91. L-Leucine  
92. L-Lysine  
93. L-Lysine 
monohydrochloride  
94. L-Methionine  
95. L-Phenylalanine  
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 13596. L-Proline  
97. L-Theanine  
98. L-Valine  
99. Lecithin  
100. Lecithin 
phosphatidylcholine  
101. Lecithin 
phosphatidylserinr  
102. Linoleic acid (LA)  
103. Linolenic Acid , 
gamma (GLA)  
104. Lutein  
105. Lycopene  
106. Magnesium ascorbate  
107. Magnesium aspartate  
108. Magnesium carbonate  
109. Magnesiun citrate  
110. Magnesium gluconate  
111. Magnesium 
glycerophosphate  
112. Magnesium glycinate  
113. Magnesium oxide  
114. Magnesium 
phosphate  
115. Magnesium sulphate  
116. Manganese gluconate  
117. Manganese sulphate 
monohydrate  
118. Methionine  
119. Mixed carotenoids  
120. Mixed tocopherols  
121. Mixed tocotrienols  
122. Molybdenum  
123. Niacin  
124. Niacinamide  
125. Nicotinamide  
126. Nicotinic acid  
127. Octacosanol  
128. Omega3 Fish Oil  
129. Pantothenic acid  
130. Para Amino Benzoic 
Acid (PABA)  
131. Pectin  
132. Phytosterols  
133. Policosanol (sugar 
cane : saccarum 
officinarum)  134. Potassium ascobate  
135. Potassium chloride  
136. Potassium citrate  
137. Potassium gluconate  
138. Potassium iodide  
139. Potassium sulfate  
140. Protein -marine  
141. Protein -milk 
142. Protein -rice 
143. Protein -soy 
144. Pyridoxine 
hydrochloride  
145. Quercetin  
146. Retinyl a cetate  
147. Retinyl palmitate  
148. Riboflavine  
149. Riboflavine sodium 
phosphate  
150. Rutin  
151. Saccharomyces 
cerevisiae  
152. Selenomethionine  
153. Silicon dioxide  
154. Sodium ascorbate  
155. Sodium copper 
chlorophyllin  
156. Sodium molybdate  
157. Sodium molybdate 
dihydrate  
158. Sodium selenate  
159. Sodium selenite  
160. Soy isoflavone  
161. Squalene  
162. Streptococcus 
termophilus  
163. Taurine  
164. Thiamine 
hydrochloride  
165. Thiamine nitrate  
166. Threonine  
167. Tocopherol, alpha  
168. Tocopherol, d -alpha  
169. Tocopherol, dl -alpha  
170. Tocopherol acetate, 
alpha  
171. Tocopherol acetate, 
d-alpha  172. Tocopherol acetate, 
dl-alpha  
173. Tocopherol  acid 
succinate, alpha  
174. Tocopherol acid 
succinate, d -alpha  
175. Tocopherol acid 
succinate, dl -alpha  
176. Tocopheryl acetate, 
d-alpha  
177. Tocopheryl acid 
succinate, d -alpha  
178. Tocopheryl acid 
succinate, dl -alpha  
179. Tricalcium phosphate  
180. Yeast - high 
Chromium  
181. Yeast - high Selenium  
182. Yeast -dried  
183. Zeaxanthin  
184. Zinc ascorbate  
185. Zinc citrate  
186. Zinc citrate trihydrate  
187. Zinc gluconate  
188. Zinc oxide  
189. Zinc picolinate  
190. Zinc sulfate  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 136List B : List of Active ingredients that  are allowed to be combined with active 
ingredients in List A 
 
 
1. Acerola  
2. Aloe vera  
3. Allium sativum (Garlic)  
4. Bee pollen  
5. Bee propolis  
6. Borago officinalis (Borage oil)  
7. Chlorella (Chlorella pyrenoidosa, 
Chlorella sorokianiana, Chlorella 
vulgaris)  
8. Chlorophyll  
9. Camellia sinensis  
10. Evening primrose oil/Oenothera 
biennis  
11. Ganoderma  
12. Ginseng/ Panax gins eng 
13. Hordeum Vulgare (Barley)  
14. Kelp/ Laminaria sp.  
15. Linum usitatissimum (Flaxseed oil)  
 16. Medicago sativa (Alfafa)  
17. Pine bark / Pinus miritus (pinus 
massoniana, pinus pinaster)  
18. Pine pollen  
19. Propolis  
20. Rosa canina  
21. Rose hips  
22. Rosmarinus officinalis  
23. Royal jelly  
24. Seaweed  
25. Shark cartilage  
26. Shark liver oil  
27. Spirulina (Spirulina platensis)  
28. Tagetes erecta (Marigold)  
29. Vitis vinisfera (Grape seed extract)  
30. Wheat Germ Oil  
31. Wheat grass  
 
 
Note:  
- Product C lassification  is required for formulations that contain un listed 
ingredient(s)  
- Certificate of Analysis for Dioxin level is required for product containing 
ingredient(s) derived from seafood  
- Certificate of Analysis for proof of Hormone -free is required for product 
containing placenta  
- Certificate of GMP for manufacturer/supplier is re quired for the premixed 
ingredient(s) in formulation  
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1379.5 Maximum Daily Levels  of Vitamins and Minerals for Adults allowed in 
Health S upplements  
 
 
No.  
Ingredient  
  
Upper daily limit  
 1. Vitamin A  5000 IU  
2. Vitamin D  400 IU  
3. Vitamin E  400 IU  
4. Vitamin B1 (Thiamine)  300 mg  
5. Vitamin B2 (Riboflavine)  30 mg  
6. Vitamin B5 (Pantothenic acid)  200 mg  
7. Vitamin B6 (Pyridoxine)  100 mg  
8. Vitamin B12 (Cyanocobalamin)  150 mcg  
9. Vitamin C (Ascorbic Acid)  1000 mg  
10. Folic acid  15 mg  
11. Niacin (Nicotinic Acid)   500 mg  
12. Niacinamide (Nicotinamide)   250 mg  
13. Biotin  40 mg  
14. Calcium  1400 mg  
15. Copper  2 mg  
16. Iodine  300 mcg  
17. Iron  20 mg*  
18. Magnesium  400 mg  
19. Manganese  5 mg  
20. Phosphorus  1400 mg  
21. Selenium  300 mcg  
22. Zinc  25 mg  
 
(Note: * 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)  
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1389.6 Sample  
 
Testing of samp les of marketed products will be done during post -market  
surveillance . 
 
9.7 Pack Size  
 
Maximum allowable pack size is based on daily dosing for not more than six 
months.  
 
9.8 Labelling Requirement  
LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER CARTON AND 
PROPOSED PACKAGE INSERT  
 
Outer  (Carton), Inner & Blister/Strips Labels  
The following information should be present on the label of the product  
 
 Parameters  Unit 
Carton  Inner 
Labels  Blister/Strips  
1. Product Name     
2. Dosage Form    NA 
3. Name of Active Substance(s)    ** 
4. Strength of Active Substance(s)    ** 
5. Indication    NA 
6. Batch Number     
7. Manufacturing Date    NA 
8. Expiry Date     
9. Dose / Use Instruction    NA 
10. Storage Condition    NA 
11. Country’s Registration Number    NA 
12. Name & Address of Marketing 
Authorization (Product Licence) 
Holder    Name/Logo of 
Manufacturer/  
Product Owner   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 13913. Name & Address of Manufacturer    NA 
14. Warnings (if applicable)    NA 
15. Pack Sizes (unit/volume.)    NA 
16. Name & content of preservative(s) 
where present    NA 
17. Name & content of alcohol, where 
present    NA 
18. To declare source of ingredients  
(active, excipient, and /or capsule 
shell) -derived from animal origin    NA 
19. Recommended daily allowance (RDA) 
for vitamins / multivitamins / minerals  
preparations used as Health 
Supplements (optional)    NA 
20. The words “Keep out of reach of 
children” or words bearing similar 
meaning in both Bahasa Malaysia & 
English    NA 
21. Other country specific labeling 
requirements (if applicable)    NA 
 
            NA - Not applicable                    
** For multi -vitamins and minerals preparations it is suggested to label as 
multi -vitamins and minerals  
 
If the product is without an outer carton, the inner label should bear all the 
information that is required  
 
Package inserts  (Optional)  
 
The following information is required to be included in the package insert:  
(i) Brand or Product Name  
(ii) Name and Strength of Active Substance(s)  
(iii) Product Description  
(iv) Indication  
(v) Dose / Use Instruction    
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 140(vi) Contraindications  
(vii) Warnings and Precautions  
(viii) Interactions with Other Medications  
(ix) Statement on usage during pregnancy and lactation  
(x) Adverse Effects / Undesirable Effects  
(xi) Overdose and Treatment  
(xii) Storage Conditions (may be omitted if the information is stated on the 
label or outer carton labels)  
(xiii) Dosage Forms and packaging available  
(xiv) Name and Address of manufacturer/marketing authorization holder  
(xv) Date of Revision of Package Insert  
 
 
Standard Labeling  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Batch number, manufacturing date, expiration date : can be stated on label, 
on top of cap or bottom of bottle  
  Name and  Strength of active  
substances, RDA  
 Preservative(s) (where  
present)  
 Alcohol (where present)  
 
 Indication  
 Dose / Use Instruction  
 
 
 Functional Claim  
 Warnings (If applicable)  
 
 
 
 Storage Condition  
 Keep out of reach              
of children / Jauhi dari  
kanak -kanak  
  Name & address 
of Marketing 
Authorization 
Holder  
 Name & address 
of Manufacturer  
 Name & address 
of Repacker (if 
applicable)  
 
 Sources (animal 
origin)  
 Batch Number  
 Manufacturing 
Date  
 Expiry Date  
 
MAL …………… ………...   Pack Size  
 Dosage Form    
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1419.9 Functional Claims for Health Supplement Products  
 
 
No  
Item 
  
Claims allowed  
 
1.  
Vitamin A   
 Maintenance of good health  
 Helps to maintain growth, vision and  tissue 
development  
 Aids in maintaining the health of the skin and 
mucous membrane  
  
 
2.  
Vitamin C   
 For healthy bones, teeth, gums as well as 
general make -up of the body  
 
 
3.  
Vitamin D   
 Maintenance of good health  
 Helps in normal development and maintenance 
of  bones and teeth  
 Helps the body utilize calcium and phosphorus  
 Claim for specific population subgroups:  
- Elderly people who are confined indoors  
 
 
4.  
Vitamin E   
 Maintenance of good health  
 
 
5.  
Beta Carotene   
 Maintenance of good health  
 Helps in maintenance of growth, vision and 
tissue differentiation  
  
 
6.  
Thiamine  
(Vitamin B1)   
 Helps to maintain good health  
 Helps normal growth  
 Helps the body to metabolize carbohydrates  
 
 
7.  
Riboflavin  
(Vitamin B2)  
 A factor in maintenance of good health  
 Helps the body to utilize energy from food/ 
metabolize proteins, fats and carbohydrates  
 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  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 142 
8.  
Niacin  
(Vitamin B3)   
 A factor in maintenance of good health  
 Helps normal growth and development  
 Helps the body in utilization of energy from 
food 
 
 
9.  
Pyridoxine  
(Vitamin B6)   
 A factor in maintenance of good health  
 Helps the body to metabolize proteins, fats and 
carbohydrates  
 
 
10.  
Cyanocobalamine  
(Vitamin B12)   
 Helps in maintenance of good health  
 Helps in the formation of red blood cell  
 
 
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 in maintenance of good health  
 Helps to metabolize fats and carbohydrates  
 
 
13.  
Pantothenic Acid   
 Helps in maintenance of good health  
 Helps to metabolize fats and carbohydrates  
 
 
14.  
Calcium   
 Helps in maintenance of 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 sufficient daily 
intake to help in proper bone formation 
in developing baby  
 
 
15.  
Phosphorus   
 Helps in maintenance of good health  
 Helps in the formation and maintenance of 
bones and teeth  
 
16.  
Magnesium   
 Helps in maintenance of good health  
 Helps the body to metabolize carbohydrate   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 143 
17.  
Iron  
 Helps in maintenance of good health  
 Helps in the formation of red blood cell  
 Helps to prevent iron anemia  
 Helps to prevent anemia due to iron deficiency  
 
 
18.  
Iodine   
 Helps in maintenance of good health  
 Helps in the function of the thyroid glands  
 
 
19.  
Zinc  
 A factor in maintenance of good health  
 Helps to metabolize carbohydrates, fats and 
protein  
 
 
20.  
Copper   
 A factor in maintenance of good health  
 Helps in the formation of red blood cell  
 
 
21.  
Manganese   
 A factor in maintenance of good health  
 Helps the body to metabolize carbohydrates 
and proteins.  
 
 
22.  
Probiotics   
 Helps improve a beneficial intestinal microflora  
 
 
 
 
9.10   List of Non Permissible Product Name for Health Supplement  Products  
 
Bil. Perkara  Contoh  
1. , Tidak dibenarkan menggunakan nama 
penyakit yang tidak boleh diiklan di 
bawah Akta Ubat (Iklan &  Penjualan) 
1956 (Disemak 1983)  Contoh : -  
Diabetes, Asma, Kanser  
 
 
 
2.  Tidak dibenarkan menggunakan nama 
bagi satu bahan aktif sebagai nama 
produk sekiranya produk tersebut 
mengandungi beberapa bahan aktif 
kecuali ianya ditambahkan dengan 
perkataan sepert i ‘Plus, Compound, 
Complex, Herbanika, Enrich  
 Contoh : - 
Kapsul Tongkat Ali   ----  
Tetapi produk  mengandungi  
Tongkat Ali , ginseng dan lain -lain 
bahan  
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1443.  Tidak dibenarkan menggunakan nama 
superlatif . 
Nama yang menunjukkan efikasi yang 
melampau  
 Contoh :- 
Power, Superior, Pure, Mustajab,  
Safe, Healthy, Penawar, VIP, 
Good  
4.  Tidak dibenarkan menggunakan nama 
yang mengelirukan dari segi ejaan dan 
sebutan .  
Mengambil sebahagian /separuh dari: -  
- 20 nama penyakit yang tidak 
dibenarkan di dalam Akta 
Ubat 1956 (Iklan &  
Penjualan) (Disemak 1983)  
ii) penyakit -penyakit  lain tanpa bukti 
saintifik  
iii) indikasi yang tidak dibenarkan  
 Contoh: - 
a) Go Out = GOUT (label)  
b) Utix  
 
5.  Tidak dibenarkan menggunakan nama 
yang mengelirukan dari segi maksud . 
Nama produk yang boleh dipertikaikan 
maksudnya.  
 Contoh: - 
B For Energy ?  
6.  Tidak dibenarkan menggunakan nama 
yang bercanggah dengan taraf tata 
susila/ kesopanan  
Nama yang mana jika ditafsirkan akan 
bercanggah/melanggar taraf tata susila/ 
kesopanan di kalangan masyarakat 
Malaysia  
 Contoh: - 
SENXBIG=SEnXBIG(label)  
Sexy,Enjoy,Paradise,Heavenly,  
Blue boy,Casanova, Desire  
 
 
7.  Tidak dibenarkan menggunakan nama 
produk yang tidak selaras dengan 
indikasi yang dipohon  
Nama produk memberi gambaran untuk 
satu indikasi tetapi sebenarnya terdapat 
beberapa indikasi yang dipohon.  
 Contoh: - 
Ubat Batuk X= Indikasi yang 
dipohon pula adalah untuk batuk, 
pening kepala,selsema dan 
kegatalan.  
 
    8. Tidak dibenarkan menggunakan nama 
produk yang membawa maksud 
kepercayaan karut   
Kenyataan –kenyataan yang merujuk 
kepada bahan -bahan purbakala / 
makhluk halus / kuasa -kuasa luarbiasa   Contoh  :- 
Perkataan –perkataan seperti 
hikmat, berhikmat, ajaib, 
keajaiban, kesucian, kesyurgaan, 
(Miracle, magic, magical, 
miraculous, saintly, heavenly)  
 
9. Tidak dibenarkan menggunakan nama 
produk yang seakan -akan sama 
dengan produk yang telah berdaftar.  Contoh: - 
Tenormin vs Tenormine vs 
Tenormy   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 145Nama menyerupai nama produk yang 
telah berdaftar dari segi ejaan & sebutan  
 Re-Liv vs Re -Lif 
10. Tidak dibenarkan menggunakan nama 
produk yang mengelirukan samada 
drug/ makanan/minuman  
Nama yang menyerupai produk 
makanan/minuman  
 Contoh: - 
Juice, Health drink, Beverage, 
Kooky  
11. Tidak dibenarkan menggunakan nama 
yang melambangkan nasihat 
Profesional – tanggapan nasihat  
 Contoh: - 
Dr Sunny, Dr Noortier Rooibose 
Tea, Professor  
12. Tidak dibenarkan menggunakan nama 
yang melambangkan pengurangan 
berat badan / melangsingkan badan  Contoh : - 
Slim, Langsing, Trim,  Trimnfit  
13. Lain –lain nama produk yang tidak 
dibenarkan  
 Contoh : - 
Minda, IQ , Smart , Ultra Mega, 
Detox  
 
 
English Version  
 
Appendix 9.10 List of Non Permissible Product Name for Health Supplement 
Products  
 
No. Issue  Example  
1.  Prohibited use of disease names as 
stated in the Medicines (Advertisement 
and Sale) Act 1956 (Revised 1983)  Example :  
Diabetes, Asthma, Cancer  
2.  Prohibited use of a single active 
ingredient as a product name in 
products containing more than one 
active ingredient unless product name 
contains words such as ‘Plus, 
Compound, Complex, Herbanika  Example :  
Tongkat Ali Capsule ---- 
But product contains tongkat ali, 
ginseng, ect.  
3.  Prohibited use of superlative - Names 
which indicates superiority inefficacy  Example :  
Power, Superior, Pure, Mustajab, 
Safe, Healthy, Penawar, VIP, 
Good  
4.  Prohibited use of spelling of words 
which may cause confusion  
Words which involve names of/part 
thereof:  
i) 20 disease names prohibited in the 
Medicines (Advertisement and Sale) Act 
1956 (Revised 1983)  Example :  
a) Go Out = GOUT (label)  
b) UTix   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 146ii) Other diseases without scienti ﬁc proof  
iii) Prohibited indication  
5.  Prohibited use of names which may 
cause ambiguity  
Ambiguous product name  Example:  
B For Energy?  
6.  Prohibited use of names which may be 
offensive or indecent  Example:  
SENXBIG=SEnXBIG(label)  
Sexy, Enjoy, Paradise,  
Heavenly, Blue boy, Casanova, 
Desire  
7.  Prohibited use of product names 
which are incoherent with the 
approved indication  
Name containing a product claim 
whereas product is indicated for more 
than the approved indication  Example:  
Cough Syrup X= Approved 
indication for cough, dizziness, ﬂu 
and itch  
8.  Prohibited use of product names 
which has elements of ludicrous belief  
Statements referring to ancient believe/ 
negative spirits/supernatural power  Example:  
Words such as miracle, magic, 
magical, miraculous, saintly, 
heavenly  
9.  Prohibited use of product names 
similar to the existing approved 
product names  
Product names  similar to the spelling and 
pronunciation of words of the existing 
product names  Example:  
Tenormin vs Tenormine vs 
Tenormy  
Re-Liv vs Re -Lif 
10.  Prohibited use of product names 
which may cause ambiguity in the 
nature of product (drug/food/beverage)  
Product n ames similar to a food/beverage 
product  Example:  
Juice, Health drink, Beverage, 
Kooky  
11.  Prohibited use of product names 
which represents professional advice 
or opinion  Example:  
Dr Sunny, Dr Noortier Rooibose 
Tea, Professo  
12.  Prohibited use of product names 
which represent weight loss/slimming 
properties  Example:  
Slim, Langsing, Trim, Trimnfit  
13.  Other prohibited product names  Example:  
Minda, IQ, Smart , Ultra Mega, 
Detox  
 
*This list is not meant to be exhaustive.  
*It may be reviewed as and when it is deemed necessary  
*DCA reserves the right to disallow any other wor ds or phrases for product names 
which in its opinion is misleading, improper or not factual  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 147Appendix 10: Guide to classification of Food -Drug Interface Products  
[Guide to determine if a product is  to be regulated by the National Pharmaceutical  
Control Bureau (BPFK) or the Food Quality Division (BKMM)]  
 
1. Introduction  
Malaysians are now more health conscious and there is generally greater  
awareness of the importance of the nutrition to overall well -being. In recent years,  
many consumers also rely on a variety of “dietary supplements” to improve their  
health. These supplements (sometimes refer to as “health foods”) comprise a  
diverse group of products that are now freely available through a myriad of  outlets.  
A variety of products are available in the market, supposedly for the prevention and  
even treatment of the chronic diseases. These products may range from foods  
modified to have special properties or pure forms of vitamins and minerals and  
extrac ts of various botanical or animal products. These products are marketed  
through a variety of channels and often carry a variety of functional and health  
claims. It is important to monitor and regulate the marketing and sale of these  
products so as to protect the interest of consumers.  
There are, however, various products in the market that are not clearly marketed as  
“food” or “drugs”. These have been termed as “food -drug interface products” and  
include a variety of so called health products. Previousl y, it has been difficult to  
determine which authority should regulate the marketing and sale of such products,  
i.e. BKMM or BPFK.  
This has caused difficulty to the companies intending to market such products. It is  
also not beneficial to the consumer as the products could be in the market and not  
regulated by either of the authorities. To overcome these problems and to enable a  
quick decision to be made as to which authority should regulate a particular product,  
a committee called Committee for the Classi fication of Food -Drug Interface Products  
(Jawatankuasa Pengkelasan Keluaran Food -Drug Interface) has been formed since  
year 2000. The main terms of reference of the committee is to assist the BKMM and  
BPFK in classifying an application from the industry wh ich is not clearly a food or  
drug (a food -drug interface (FDI) product) in a consistent manner. Other duties  
include advising the two divisions of the Ministry of Health in strengthening and  
updating the relevant regulations as well as to provide scientifi c input on these  
products.  
 
2. Classification of FDI  
Through a series of meetings of the Committee for the Classification of Food - Drug -
Interface Products, the Divisions of Food Quality control (BKMM) and the  National 
Pharmaceutical Control Bureau (BPFK) h as arrived at a system for the  classification 
of food -drug interface products. This classification is based on multiple  criteria 
system as follows:   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1482.1 If a product contains 80% or more of food ingredients, singly or in 
combination,  and with equal to or le ss than 20% of biologically active 
ingredients of natural  products with pharmacological and/or therapeutic 
properties, the product has to be  regulated by BKMM.  
2.2 If a product contains less than 80% of food -based ingredients and more than  
20% of the activ e ingredients, such product should be regulated by BPFK. 
Not withstanding this general rule, for products containing specific ingredients 
which  possess high potencies, even if they contain less than 20% of the 
active ingredients,  they shall be reviewed by the Committee and may be 
regulated by BPFK if it is  found appropriate.  
2.3 If the product is a ‘pure’ form (close to 100%) of active ingredients, e.g. 
vitamins,  minerals, amino acids, fatty acids, fibre, enzymes, etc, the product 
has to be  regulated by BPF K. 
2.4 Product containing solely natural ingredients that are not traditionally used as  
food and possess medicinal value, such as alfalfa, spirulina, royal jelly, noni 
juice,  rooibos  tea, pegaga tablet and other herbal products shall be regulated 
by BPFK.  
2.5 When there is greater uncertainty about the efficacy and safety of a product,  
BPFK would be the preferred authority to regulate it. This is to enable closer 
scrutiny  of such products, to better safer guard the interest of consumers.  
 
3. Other Criteria  
The following may be used as additional criteria to assist in the classification of  
products:  
3.1 Intended use and claims made by the product. Eventually, if a product has 
been  decided to be regulated by BKMM, no claims should be made, other 
than those  permitted by the food regulations.  
3.2 Instruction for use and pharmaceutical dosage forms such as tablet, capsule.  
3.3 Formulation of the product. A product with an unusual mixture of vitamins and  
minerals and herbs would most likely to be regulated by BPFK.  
3.4 Products with unusual application or use are likely to be regulated by BPFK.  
 
4. Pictorial Guide to classification  
A pictorial guide to the classification of food -drug interface products is presented  
below: - 
PICTORIAL GUIDE TO THE CLASSIFICATION OF PRODUCTS AT THE  FOOD -
DRUG INTERFACE  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 149 
 If a product is more than 80% food based but contains pure forms of active  
ingredients (e.g., vitamins & minerals) that exceed the amounts permitted in 
the Food Regulations 1985, the company shall be advised to reduce  the 
amounts of  these active ingredients and be regulated by BKMM.  
 Intended use and claim should not be used as sole criteria for 
classification  but can be used as a guide  
 Instruction for use and pharmaceutical dosage form like tablet, capsule, 
should not  be used as criteria for classification but can be used as a guide  
 
 
 
Appendix 11: Guidance specific for OTC External Personal Care Products  
 DELETED  
 
 
 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 150Appendix 12: Guidance notes for Traditional Products  
 
Traditional medicine as defined under the Control of Drugs and Cosmetics  
Regulations 1984  means:  
Any product used in the practice of indigenous medicine, in which the drug consist  
solely of one or more naturally occurring substances of a plant, animal or mineral, of  
parts thereof, in the unextracted or cr ude extract form, and a homeopathic  medicine.  
 
Registration of Traditional Products  
The DCA has agreed on the implementation of the new approach in evaluating 
traditional products to ensure the quality and safety of the products. Focus should be 
aimed on the use of new active ingredient and product containing combination of 
ingredients.  
1. Additional data that need to be submitted:  
Product containing new single ingredient:  
   a) Extract form  
i. Information on the taxonomy of the ingredient  
ii. Techniques and methods in preparing/processing the extract and subsequently 
the product  
iii. Information on the use and safety of the ingredient and the product  
iv. Quality standard  
   b) Powder/Granules  
i. Information on the taxonomy of the ingredient  
ii. Techniques and methods in preparing/processing the extract and subsequently 
the product  
iii. Information on the use and safety of the ingredient and the product  
 Product containing multiple ingredients (contains ingredients which are known 
to be used traditionally):  
i. The source of the product formulation  
e.g. Chinese Pharmacopoeia   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 151ii. Proof or e vidence of the use, traditionally  
Product containing multiple ingredients (contains ingredients which are not known to 
be used traditionally):  
i. Information on the use and safety of every new ingredient  
ii. Safety data on the new formulation  
2. Quality  Testing  
Sample for testing should be submitted together with application form at the stage 3 
submission.  
Effective from 1 December 2007, premixed ingredient(s) shall not be used in 
traditional products formulation  
 
12.1 LIST OF PROHIBITED BOTANICALS (HERBS AND HERBAL  
DERIVATIVES)  
i) Botanicals (and botanical ingredients) containing scheduled poisons  as 
listed under the Poisons Act 1952  
Aconitum  
Asidosperma quebracho  
Atropa belladona  
Black nightshade  
Berberis  
Calabar bean (physostigma venenosum)  
Cabola  albarrane (squill)  
Chondodendron tomentosum  
Colchicum autumnale  
Datura metel  
Datura stramonium  
Digitalis purpurea folium  
Drimia maritima (Squill)  
Ephedra Herbs  
Foxglove leaf  
Gelsemium sempervirens  
Hyoscyamus muticus   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 152Hyoscyamus niger  
Larrea tridenata  
Larnea Mekicara  
Lobelia inflata  
Lobelia nicotianifolia  
Mitragyna speciosa Korth. (mitragynine)  
Nicotinana Tabacum (solanine)  
Nux Vomica  
Papaver somniferum  
Physostigma veneosum (Calabar Bean)  
Pilocarpus microphyllus  
Puasinystalia yohimbe  
Rauwolfia serpentina  
Rauwolfia vomitoria  
Schoenocaulonofficinale  
Scillae bulbus (Squill)  
Solanum nigrum (Black nightshade)  
Strychnos nuxvomica  
Urginea maritima (Squill)  
Urginea Scill (Squill)  
Valerian extract (Valepotriates)  
 
ii) Botanicals (& botanical ingredients)  which are banned  
1. Dryabalanops aromatica & Borneolum syntheticum (Contain camphor & 
borneol - not allowed in preparations for oral use)  
2. Chapparal (Larrea tridentate & Larrea mexicana)   
(Reported to cause liver toxicity).  
3. Hydrastis canadensis  
(Reported to c ause disturbance of the nervous system)  
4. Magnolia officinalis  
(Reported to cause kidney toxicity)  
5. Stephania tetrandra  
(Reported to cause kidney toxicity)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1536. Piper methysticum (kava -kava)  
(Reported to cause liver toxicity)  
7. Aristolochic Acid**  
(Reported to cause  kidney toxicity)  
8. Comfrey (Symphytum officinale, S. asperum, S. x. uplandicum)  
(Reported to cause liver toxicity)  
9. Senacio spp (Senecio aureus, S.jacobaea, S. bicolor, S.  nemorensisi, S 
vulgaris, S. longilobus, S. scandens Buch. -Ham)  
(Reported to cause live r toxicity)  
 
** To identify the Botanicals which may contain Aristolochic Acid (A. A.),  
please refer to:  
a. List A - Botanicals Known or Suspected to contain Aristolochic Acid;  
b. List B - Botanicals which may be Adulterated with Aristolochic Acid  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 154 
 
 
(Source for Lists A and B)  
 
U. S. Food and Drug Administration  
Center for Food Safety and Applied Nutrition  
Office of Nutritional Products, Labeling, and  
Dietary Supplements  
[Revised April 9, 2001 ] 
 
List A  
Botanicals Known or Suspected to Contain Aristolochic Acid  
 
 
Botanical Name*      
    
Common or Other Names  
Aristolochia  spp. Aristolochia  
Guan mu tong  
Guang mu tong  
Aristolochia acuminata Lam.  
Syn. Aristolochia tagala Champ.  Oval leaf  
Dutchman's pipe  
Aristolochia argentina Griseb.   
Aristolochia baetica Linn.  
Syn. Aristolochia bracteolata Lam.   
Aristolochia bracteata 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 homens  
 
Aristolochia debilis Siebold & Zucc.  
Syn. Aristolochia longa Thunb.  
Syn. Aristolochia recurvilabra Hance  Ma dou ling  
Tian xian teng  
Qing mu xiang  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 155Syn. 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  
 
 
 
 
 
 
 
 
Aristolochia fimbriata Cham.  
 Guang fang ji  
Fang ji  
Mokuboi  
(Japanese)  
Kwangbanggi  
(Korean)  
Fang chi  
Kou-boui  
(Japanese)  
Aristolochia indica L.   Indian birthwort  
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  
 Yellowmouth  
Dutchman's pipe  
 
Aristolochia kwangsiensis Chun & F.C. How  
Syn. Aristolochia austroszechuanica C. B. Chien & 
C. Y.  
Cheng  
  
 
Aristolochia macrophylla Lam.  
Syn. Aristolochia sipho L'Hér.  
 Dutchman's -pipe 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 156Aristolochia manschuriensis Kom.  
Syn. Hocquartia manshuriensis (Kom.) Nakai  
Syn. Isotrema manchuriensis (Kom.) H. Huber  
 
 
 
 
 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 hoffmannii Klotzsch  
  
Aristolochia mollissima Hance  
  
Aristolochia pistolochia L.  
  
Aristolochia rigida Duch.  
  
Aristolochia rotunda Linn.  
  
Aristolochia serpentaria L.  
Syn. Aristolochia serpentaria var. hastata (Nutt.) 
Duch.  
 Virginia  
snakeroot  
Serpentaria  
Virginia  
serpentary  
 
Aristolochia watsoni Wooton & Standley or  
Aristolochia watsonii Wooton & Standley  
Syn. Aristolochia porphyrophylla Pfeifer  
  
Aristolochia westlandii Hemsl. or Aristolochia 
westlandi Hemsl.  
  
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.    
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 157 
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. reflexum (E.P. 
Bicknell) B.L.  
Rob.  
Syn. Asarum furcatum Raf.  
Syn. Asarum medium Raf.  
Syn. Asarum parvifolium Raf.  
Syn. Asarum reflexum E.P. Bicknell  
Syn. Asarum rub rocinctum Peattie  
 Wild ginger  
Indian ginger  
Canada  
snakeroot  
False 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 name as cited in J. Nat. Products 
45:657 -666  
(1982)  
  
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 158List B  
Botanicals which may be Adulterated with Aristolochic Acid  
 
Botanical Name*  
 Common or Other Names  
Akebia spp.  
 Akebia  
Mu tong  
Ku mu tong  
Zi mutong  
Bai mu tong  
Mokutsu (Japanese)  
Mokt'ong (Korean)  
 
Akebia quinata (Houtt.) Decne.  
Syn. Rajania quinata Houtt.  
 Chocolate vine  
Fiveleaf akebia  
Mu tong  
Yu zhi zi  
Mokutsu (Japanese)  
 
Akebia trifoliata (Thunb.) Koidz.  
 Mu tong  
Three leaf akebia  
Yu zhi zi  
 
Asarum forbesii Maxim.  
 Batei -saishin  
(Japanese)  
 
Asarum heterotropoides F. Schmidt  
Syn. Asarum heterotropoides F. Schmidt  
Syn. Asiasarum heterotropoides (F. Schmidt) F. 
Maek.  
 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. seoulensis 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   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 159Clematis 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 biondiana Pavol.  
Syn. Clematis ornithopus Ulbr.  
 Armand's clematis  
Chuan mu tong  
(stem)  
Xiao mu tong  
Armand's virgin  
bower  
Clematis chinensis Osbeck.  
 Chinese clematis  
Wei ling  xian (root)  
 
Clematis hexapetala Pall.  
  
Clematis montana Buch. -Ham. ex DC.  
Syn. Clematis insulari -alpina Hayata  
  
Clematis uncinata Champ. ex Benth.  
Syn. Clematis alsomitrifolia Hayata  
Syn. Clematis chinensis var. uncina ta (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 & 
C.H. Ou  
  
Cocculus spp.  Cocculus  
 
Cocculus carolinus (L.) DC.  
Syn. Cebatha carolina Britton  
 
Syn. Epibaterium carolinum (L.) Britton  
Syn. Menispermum carolinum L.    
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 160Cocculus diversifolius DC.  
Syn. Cocculus madagascariensis Diels  
  
Cocculus hirsutus (L.) Diels  
Syn. Cocculus villosus DC.  
Syn. Menispermum hirsutum L.  
   
Cocculus indicus Royle  
Syn. Anamirta paniculata Colebr.  
 Indian cockle  
 
Cocculus laurifolius DC.  
Syn. Cinnamomum esquirolii H. Lév.  
  
Cocculus leaebe DC.  
  
Cocculus madagascariensis Diels  
Syn. Cocculus diversifolius DC.  
  
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  
 
Cocculus pendulus Diels  
Syn. Cebatha pendula (J.R. & C. Forst.) Kuntze  
Syn. Epibaterium pendulus Forst. f.  
Syn. Cocculus Epibaterium DC.  
  
Cocculus pendulus (Forst. & Forst.) Diels  
  
Cocculus palmatus Hook.  
Syn. Jateorhiza Miersii Oliver  
 Colombo  
 
Cocculus thunbergii DC.  
   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 161Diploclisia affinis (Oliv.) Diels  
Syn. Diploclisia chinensis Merr.  
Syn. Cocculus affinis Oliv.  
  
Diploclisia chinensis Merrill  
 Xiangfangchi  
Menispernum dauricum  
  
Saussurea lappa (Decne.) Sch. Bip.  
 Mokkou (Japanese)  
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. cinereum (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  
 
Stephania tetrandra S. Moore  
 
 
 
 
 
Vladimiria souliei (Franch.) Ling Fen fang ji , fang ji  
Fang ji (root)  
Han fang ji  
Kanboi (Japanese)  
Hanbanggi (Korean)  
Fun-boui (Japanese)  
Sen-mokkou  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 16212.2 WILDLIFE WHOSE USE IS PROHIBITED IN TRADITIONAL MEDICINE  
 
Traditional products are prohibited from containing ingredients derived from the body  
/body parts of the 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. Please refer to t he said ACT for the complete list.  
(HIDUPAN LIAR YANG DILARANG DIGUNAKAN DIDALAM UBAT 
TRADISIONAL)  
(Ubat -Ubat tradisional adalah di larang mengandungi bahan -bahan/ bahagian 
anggota haiwan -haiwan yang disenaraikan didalam AKTA PERLINDUNGAN  
HIDUPAN LIAR 1972 . 
Beberapa contoh haiwan dan burung yang mana penggunaannya dilarang adalah 
seperti disenaraikan di bawah. Sila rujuk kepada AKTA tersebut untuk senarai 
lengkap.)  
 
FIRST SCHEDULE  
COMPLETELY PROTECTED WILDLIFE SPECIES  
(JADUAL SATU)  
(BINATANG -BINATANG LIAR YAN G DIPERLINDUNGI SEPENUHNYA):  
 
 
1. Javan Rhinoce ros   (Rhinoceros sondaicus)   Badak     
                                                                                                       Raya  
 
2. Sumatran Rhinoceros   (Didermocerus suma trensis)  Badak    
                                   Kerbau  
  
3. Tapir     (Tapirus indicus)    Badak chipan,  
badak tampong  
 
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 alpinus)    Serigala,  
Anjing hutan  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 16310. Clouded Leopard   (Neofelis nebulosa)    Harimau dahan  
 
11. Marbl ed Cat    (Felis marmorata)    Kucing dahan  
 
12. Flat -headed Cat   (Felis planiceps)    Kucing hutan  
 
13. Golden Cat    (Felis temminckii)    Kucing tulap  
 
14. Linsang     (Prionodon linsang)    Linsang  
  
15. Binturong or Bear -cat   (Artictis b inturong)    Binturong  
 
16. Slow Loris    (Nycticebus coucang)   Kongkang,  
Kera duku  
 
17. Otter civet    (Cynogale bennettii)   Musang  
Memerang  
  
18. Derby's Banded Civet  (Hemigalus derbyanus)   Musang  
Belang  
 
19. Yellow -throated Marten  (Martes flavigula)    Mengkira  
 
20. Weasel     (Mustela nudipes)    Pulasana  
 
21. Long -tailed porcupine   Trichys lipura)    Landak padi  
 
22. Serow     (Capricornis sumatrensis)   Kambing Gurun  
  
23. Selangor Pigmy  (Petaurillus kinlochii)   Tupai  Terbang   
       Flying Squirrel         Terkecil  
 
24. Red -cheeked    (Hylopetes spadiceus)   Tupai Terbang  
      Flying Squirrel         Pipi Merah  
 
25. Grey -cheeked    (Hylopetes lepidus)    Tupai Terbang  
Flying  Squirrel          Pipi Kelabu  
 
26. Whiskered  Flying Squi rrel  (Petinomys genebarbis)   Tupai Terbang  
Berjambang  
 
27. White -Bellied F lying   (Petinomys setosus)   Tupai Terbang  
      Squirrel          Dada Puteh   
 
28. Vordermann's Flyi ng   (Petinomys vordermanni)   Tupai Terbang  
      Squirrel          Kecil  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 16429. Horsfield's Flying Sq uirrel  (Iomys horsfieldii)    Tupai Terbang  
Ekor Merah  
 
30. Smoky Flying Squirrel   (Pteromyscus pulverulentus)  Tupai Terbang  
Kotor  
 
31. Large Black Flying Squ irrel  (Aeromys tephromelas)   Tupai Terbang  
Hitam  
 
32. Red Giant Flying Squirrel  (Petaurista Petaurista)   Tupai Terbang  
Merah  
 
33. Spotted Giant Flying  (Petaurista elegants)   Tupai Terbang  
      Squirrel       Bintang  
 
34. Malayan Flying Lemur   (Cynocephalus variegatus)    Kubong  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 165SECOND SCHEDULE  
PROTECTED WILDLIFE SPECIES  
(JADUAL DUA)  
(BINATANG -BINATANG LIAR YANG DIPERLINDUNGI)  
 
Bahagian I - Binatang -binatang Perburuan Besar  
 
1. Elephant     (Elephas maximus)    Gajah  
 
2. Gaur     (Bos gaurus hubbacki)   Seladang  
 
Bahagian  II - Binatang -binatang Perburuan  
  
1. Sambur Deer    (Cervus unicolor equinus)   Rusa  
 
2. Barking Deer    (Munctiacus muntjak)   Kijang  
 
3. Large Mouse -Deer   (Tragulus napu)    Napoh  
 
4. Lesser Muose -Deer   (Tragulus javanicus)   Pelandok  
 
5. Tiger     (Panthera tigris)    Harimau  
belang  
 
6. Leopard     (Panthera pardus)    Harimau  
bintang, harimau 
kumbang.  
 
7. Malayan Honey -Bear   (Helarctos malayanus)   Beruang  
 
8. Wild Pig     (Sus scrofa)     Babi Hutan  
  
9. Bearded Pig    (Sus b arbatus)    Babi bodoh  
 
Bahagian III - Binatang -binatang Liar Lain yang diperlindungi  
 
1. Hairy -nosed Otter   (Lutra suma trana)   Memberang  
Hidung  
  
2. Smooth Otter    (Lutra perspillata)   Memberang  
Licin 
    
3. Common Otter    (Lutra lutra)    Memberang  
Utara  
 
4. Small -clawed Otter   (Amblonyx cinerea)   Memberang  
Kecil   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 166 
5. Common Palm Civet   (Paradoxurus   Musang Pulut  
hermaphroditus)  
 
6. Malay Civet    (Viverra tangalunga)  Musang  
tenggalong  
 
7. Large Indian Civet   (Viverra zibetha)   Musang Jebat  
 
8. Large Spotted Civet   (Viverra megaspila)   Musang Titek  
Besar  
 
9. Masked Palm Civet   (Peguma larvata)   Musang lamri  
  
10. Small -toothed Plam Civet  (Arctogalidia trivirgata)  Musang akar  
 
11. Little Civet    (Viverracula malaccensis)  Musang bulan  
 
12. Short -tailed Mongoose  (Herpestes brachyurus)  Bambun ekor  
pendek  
 
13. Small Indian Mongoose  (Herpestes    Cherpelai,  
auropunctatus)   bambun kecil  
 
14. Indian G rey Mongoose  (Herpestes edwardsii)  Bambun K elabu  
 
15. Javan Mongoose   (Herpestes javanicus)  Bambun Jawa  
 
16. Leopard  Cat    (Felis bengalensis)   Kucing Batu  
 
17. Pig -tailed Macaque   (Macaca nemestrina)  Berok  
 
18. Long -tailed Crab -eating   (Macaca fascicularis)  Kera  
Macaque  
 
19. Banded Le af-Monkey   (Presbytis melalophos)  Lotong Cheneka  
  
20. Dusky Leaf -Monkey   (Presbytis obscura)   Lotong  
Chengkong  
 
21. Silvered Leaf -Monkey   (Presbytis cristata)   Lotong Kelabu  
 
22. Malayan Porcupine   (Hystrix brachyura)   Landak Raya  
 
23. Brush -tailed porcu pine   (Atherurus macrourus)  Landak nibong,  
landak batu  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 16724. Prevost's Squirrel   (Callosciurus prevostii)  Tupai Gading  
 
25. Common Giant Sq uirrel or  (Ratufa affinis)   Tupai Kerawak  
Cream -Coloured Giant Squirrel     Putih -kuning  
 
26. Black Giant Squirrel   (Ratufa bicolor)   Kerawak Hitam  
 
27. Malayan Flyin g Fox   (Pteropus vampyrus)  Kluang  
 
28. Island Flying Fox   (Pteropus hypomelanus)  Kluang Kecil  
 
29. Crocod ile    (Crocodylus porosus)  Buaya Tembaga  
 
30. Malayan Gharial   (Tomistoma schlegeli)  Buaya julong -julong  
 
31. Pyth on     (Python reticulatus)   Ular Sawa  
 
32. Water Mo nitor    (Varanus salvator)   Biawak Air  
  
33. Clouded Monitor   (Varanus  nebulosus)  Biawak Tikus  
 
34. Harlequin Mon itor   (Varanus rudicollis)   Biawak Serunai  
 
35. Dumeril's Monitor   (Varanus dumerili)   Biawak Kudong  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 168THIRD SCHEDULE  
COMPLETELY PROTECTED WILD BIRDS  
(JADUAL TIGA)  
(BURUNG -BURUNG LIAR YANG DIPERLINDUNGI SEPENUHNYA)  
 
Grebes, family Podicipididae  
1. Little Grebe (Podiceps ruficollis)  
 
Petrels, family Hydrobatidae  
2. Wilson's Storm Petrel (Oceanitis Occeanicus)  
3. Leach's Petrel (Oceanodroma leucorhoa)  
 
Tropic Birds, family Phaethontidae  
4. Short -tailed Tropic Bird (Phaethon aethereus)  
 
Pelicans, family Pelecanidae  
5. White Pe lcian (Pelecanus onocrotalus) Undan Putih  
6. Spotted -Billed Pelican (Pelecanus roseus) Undan Paroh Titik  
 
Grannets and boobies, family sulidae  
7. Brown booby (Sula leucogaster) Dendang Laut  
8. Masked Gannet (Sula dactylatra)  
 
Cormorants, family Phalacrocoracidae  
9. Common Cormorant (Phalcrocorax carbo) Dendang Air  
 
Darters, family Anhingidae  
10. Darter (Anhinga anhinga) Burung Kosa  
 
Frigate Birds, family Fregatidae  
11. Christmas Island Frigate -bird (Fregata andrewsi) Burung Simbang Pulau  
Christmas  
12. Lesser Frigate -bird (Fregat a ariel) Burung Simbang Kecil  
 
Herons, family Ardeidae  
13. Dusky -grey Heron (Ardea sumantrana) Burung Lembu  
14. Grey Heron (Ardea cinerea) Burung Seriap  
15. Purple Heron (Ardea purpurea) Burung Serandau  
16. Little Green Heron (Butorides striatus) Puchong Keladi  
17. Chinese Pond Heron (Ardeola bacchus)  
18. Cattle Egret (Bubulcus ibis) Burong Bangau  
19. Large Egret (Egretta garzetta) Burung Bangau Besar  
20. Little Egret (Egretta garzetta) Burung Bangau Kecil  
21. Chinese Egret (Egretta eulophotes) Burung Bangau China  
22. Intermediate Egret (Egretta intermedia)  
23. Reef Egret (Egretta sacra) Puchong Batu  
24. Night Heron (Nycticorax nycticorax) Burung Kuak   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 16925. Tiger Bittern (Gorsachius melanolophus)  
26. Chinese Little Bittern (Ixobrychus sinensis) Puchong Merah  
27. Cinnamon Bittern (Ixobrychus cinnamomeus) Puchon g Bendang  
28. Von Schrenck's Bittern (Ixobrychus eurhythmus) Puchong Gelam  
29. Black Bittern (Dupetor Flavicollis) Puchong Hitam  
30. Great Bittern (Botaurus Stellaris)  
 
Stork, family Ciconiidae  
31. Milky Stork (Ibis cinereus) Burung Upeh  
32. Painted Stork (Ibis leucocephalus)  
33. White -necked Stork (Ciconia episcopus)  
34. Storm's Stork (Ciconia stormi)  
35. Lesser Adjutant Stork (Leptoptilos javanicus) Burung Botak  
 
Ibises, Family Threskiornithidae  
36. White Ibis (Threskiornis aethiopica) Burung Sekendi  
 
Hawks and Eagles, family Accipitridae  
37. Bat Hawk (Machaerhamphus alcinus) lang Malam  
38. Jerdons's Baza (Aviceda jerdoni)  
39. Black -crested Baza (Aviceda leuphotes)  
40. Crested Honey Buzzard (Pernis ptilorhynchus) Lang Lebah  
41. Black -eared kite (Milvus migrans)  
42. Common Buzzard (Buteo buteo)  
43. Grey -faces Buzzard -Eagle (Butastur indicus)  
44. Black Eagle (Ictinaetus malayensis) Lang Hitam  
45. White -bellied Sea -eagle (Haliaeetus leucogaster) Lang Siput  
46. Grey -headed Fishing Eagle (Ichthyophaga ichthyaetus)  
47. Lesser Fishing Eagle (Ichthyophaga nana) Lang Kangok  
48. King Vulture (Torgos calvus) Burung Hereng  
49. Long -billed Vulture (Gyps indicus) Burung Hereng Paroh Panjang  
50. White -backed Vulture (Pseudogyps bengalensis) Burung Hereng Belakang  
Putih  
51. Hen Harrier (Circus cyaneus)  
52. Pied Harrier (Circus melanoleucos)  
53. Marsh Harrier (Circus ae ruginosus) Lang Kepala Puteh  
54. Short -toed Eagle (Circaetus gallicus) Lang Jari Pendek  
 
Osprey, family Pandionidae  
55. Osprey (Pandion haliaetus) Lang Tiram  
 
Falcons, family Falconidae  
56. Red-breasted Falconet (Microhierex caerulescens) Lang Rajawali  
57. Peregrine Falcon (Falco peregrinus)  
58. Kestrel (Falco tinnunculus)  
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 170Pheasants, partidges, etc, family Phasianidae  
59. Long -billed Partridge (Rhizothera longirostris) Burung Selanting  
60. Black Wood Partridge (Melanoperdix nigra) Burung Bertam  
61. Bare -throated Tree Partridge (Arb orophila brunneopectus) Sang Serok 
Gunung  
62. Chestnut -breasted Partridge (Arborophila charlaeni) Sang Serok  
63. Ferruginous Wood Partridge (Caloperdix oculea) Sang Serok Rimba  
64. Roulroul (Rollulus roulroul) Burung Siul  
65. Crestless Fire -backed Pheasant (Lophura erythr opthalma) Merah Mata  
66. Crested Fire -backed Pheasant (Lophura ignita) Burung Pegar  
67. Malay Peacock Pheasant (Polyplectron Malacensis) Merak Pongsu  
68. Rothschild's Peacock Pheasant (Polyplectron inopinatum) Kuang Chermin  
69. Rothschild's (Rheinartia Ocellata) Kuang Ray a Gunung  
70. Great Argus (Agusianus argus) Kuang Raya  
71. Green Peafowl (Pavo muticus) Merak  
 
Cranes, family Gruidae  
72. Eastern Sarus Crane (Grus antigone) Burung Keria  
 
Rails, Crakes and gallinules, family Rallidae  
73. Purple Coot (Porphyrio Porphyria) Panglin  
74. Masked Finfoot (Heliopais personata) Burung Pedendeng  
 
Jacanas, family Jacanidae  
75. Pheasant -tailed Jacana (Hydrophasianus Chirurgus) Burung Teratai  
76. Bronze -winged Jacana (Metopidius indicus)  
 
Gulls and terns, family Laridae  
77. Black -headed Gull (Larus ridibundus)  
78. White -winged Black Tern (Chlidonias leucoptera) Chamar Sayap Putih  
79. Gull-billed Tern (Gelochelidon nilotica)  
80. Common Tern (Sterna hirundo) Chamar  
81. Roseate Tern (Sterna dougalli) Chamar Jambu  
82. Black -naped Tern (Sterna sumatrana) Chamar Tengkok Hitam  
83. Bridled Tern (St erna anaetheta)  
84. Little Tern (Sterna albifrons) Chamar Kecil  
85. Crested Tern (Sterna bergii) Chamar Berjambul  
86. Lesser Created Tern (Sterna bengalensis) Chamar Kechil Berjambul  
87. Common Noddy (Anous stolidus) Chamar Hitam  
88. White -capped Noddy (Anous minutus) Chamar Topi Putih  
 
Pigeons and doves, family Columbidae  
89. Green Imperial Pigeon (Dracula aenea) Pergam  
90. Mountain Imperial Pigeon (Ducula badia) Pergam Bukit  
91. Pied Imperial Pigeon (Ducula bicolor) Rawa  
92. Red turtle dove (Streptopelia tranquebarica)  
93. Nicobar Pigeon (Caloenas nicobarica) Merpati Mas   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 171Cuckoos, family Cuculidae  
94. Red-winged crested Cuckoo (Clamator coromundus)  
95. Large Hawk Cuckoo (Cuculus sparveroides)  
96. Lesser Hawk Cuckoo (Cuculus vagans) Sewah Tekukor  
97. Hawk Cuckoo (Cuculus fugax) Sewah Tekukur Besar  
98. Indian Cu ckoo (Cuculus micropterus)  
99. Blyth's Cuckoo (Cuculus saturatus)  
100. Little Cuckoo (Cuculus poliocephalus)  
101. Banded Bay Cuckoo (Cacomantis sonnerati) Burung Takuweh  
102. Plaintive Cuckoo (Cacomantis merulinus) Burung Mati Anak  
103. Fantailed Cuckoo (Cacomantis variolosus)  
104. Emerald Cuckoo (Chalcites maculatus)  
105. Violet Cuckoo (Chalcites Xanthorhynchus)  
106. Bronze Cuckoo (Chalcites basalis)  
107. Malay Cuckoo (Chalcites malayanus)  
108. Drongo Cuckoo (Surniculus lugubris)  
109. Koel (Eudvnamis scolopacea) Burung Tahu  
110. Lesser Green -billed Malcoha (Phae nicophaeus diardi) Burung Chenok  
111. Rufous -bellied Malcoha (Phaenicophaeus sumatranus) Burung Chenok  
Kechil  
112. Large Green -billed Malcoha (Phaenicophaeus tristis) Burung Kera  
113. Raffles's Malcoha (Phaenicophaeus chlorophaeus) Burung Krak  
114. Red-billed Malcoha (Phaenic ophaeus javanicus) Burung Chenok Api  
115. Chestnut -breasted Malcoha (phaenicophaeus curvirostris)  
116. Short -toed Coucal (Centropus rectungis)  
117. Common Coucal (Centrpus sinensis)  
118. Lesser Coucal (Centropus bengalensis)  
 
Typical owls, family Strigidae  
119. Large Scops Owl (Otus sagittatus)  
120. Reddish Scops Owl (Otus rufescens)  
121. Mountain Scops Owl (Otus spilocephalus)  
122. Scops Owl (Otus scops) Burung Hantu  
123. Collared Scops Owl (Otus bakkamoena) Burung Jampok  
124. Malay Eagle Owl (Bubo sumatranus)  
125. Dusky Eagle (Bubo coromandus)  
126. Ceylon Fish Owl (Bubo zeylonicus)  
127. Fish Owl (Bubo Ketupu)  
128. Pygmy Owlet (Glaucidium brodiei) Burung Punggok Kechil  
129. Oriental Hawk Owl (Ninox scutulata) Burung Betemak  
130. Spotted Wood Owl (Strix seloputo) Burung Charek -kafan  
131. Brown Wood Owl (Strix leprogrammica)  
132. Short -eared Owl (Asio flammeus)  
 
Barn Owls, family Tytonidae  
133. Barn Owl (Tyto alba)  
134. Bay Owl (Phodilus badius) Burung Punggok Api   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 172 
Frogmouths, family Podargidae  
135. Large Frogmouth (Batrachostomus auritus) Burung Segan  
136. Gould's Frogmouth (Batrachostomus stellatus)  
137. Blyth's Frogmouth (Batrachostomus affinis)  
 
Nightjars, family Carprimulgidae  
138. Malaysian Eared Nightjar (Eurostopodus temmincki) Burung Taptibau  
139. Giant Nightjar (Eurostopodus macrotis)  
140. Migratory Nightjar (Caprimulgus indicus)  
141. Long -tailed Nightjar (Caprimulgus macruru s) Burung Kuber  
 
Swifts, family Apodidae  
142. Giant Swiftlet (Collocalia gigas)  
143. Black -nest Swiftlet (Collocalia maxima)  
144. Himalayan Swiftlet (Collocalia brevirostris)  
145. Grey -rumped Swiftlet (Collocalia fuciphaga) Layang -layang Gua  
146. White -bellied Swiftlet (Collocalia  esculenta) Layang padi  
147. White -throated Spinetail Swift (Chaetura caudacuta)  
148. Malaysian Spinetail Swift (Chaetura gigantea) Layang -layang besar  
149. White -rumped Spinetail Swift (Chaetura leucopygialis)  
150. Migrant Swift (Apus pacificus)  
151. House Swift (Apus affinis)  
152. Palm Swift (Cypsiurus parvus)  
 
Tree Swifts, family Hemiprocnidae  
153. Crested Tree Swift (Hemiprocne longipennis) Layang -layang Berjambol  
154. White -whiskered Tree Swift (Hemiprocne comata)  
 
Trogons, family Trogonidae  
155. Red-naped Trogan (Harpactes kasumba) Burung Kesumba  
156. Diard's Trogon (Harpactes diardi)  
157. Cinnamon -rumped Trogon (Harpactes orrhophaeus)  
158. Red-rumped Trogon (Harpacted duvauceli)  
159. Orange -breasted Trogon (Harpacted oreskios) Burung Gembala Rimau  
160. Red-headed Trogon (harpacted erythrocephalus)  
 
Kingfishers, fa mily Alcedinidae  
161. Common Kingfisher (Alcedo atthis) Pekaka Chitchit  
162. Deep Blue Kingfisher (Alcedo meninting) Binti -binti 
163. Blue-banded Kingfisher (Alcedo euryzona) Pekaka Bukit  
164. Black -backed Kingfisher (Ceyx erithacus) Pekaka Api  
165. Red-backer Kingfisher (Ceyx ruf idorsus)  
166. Brown -winged Stork -billed Kingfisher (pelargopsis amauroptera) Burung 
Buaya  
167. Stork -billed Kingfisher (pelargopsis capenis)  
168. Banded Kingfisher (Lacedo pulchella) Burung Kaing -Kaing Rimba   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 173169. Ruddy Kingfisher (Halcyon coromanda)  
170. White -breasted Kingfisher (Halcyon smyrnesis) Burung Pekaka Dada Putih  
171. Black -capped Kingfisher (Halycyon pileata)  
172. White -collared Kingfisher (Halcyonchloris) Raja Udang  
173. Chestnut -collared Kingfisher (Halcyon concreata) Pekaka Rimba Besar  
 
Bee-eaters, family Meropidae  
174. Bay -headed Bee -eater (Merops leschenaulti) Berek -berek  
175. Brown -breasted Bee -eater (Merops superciliosus) Berek -berek Dada  
Choklat  
176. Blue -throated Bee -eater (merops viridis) Berek -berek Rengkok Biru  
177. Red -bearded Bee -eater (Nyctiornis amicta) Berek -berek Janggut Merah  
 
Rollers, family Corcidae  
178. Burmese Roller (Coracias benghalensis)  
179. Broad -billed Roller (Eyrystomus orientalis) Tiong Batu  
 
Hoopoe, family Upupidae  
180. Hoopoe (Upupa epops)  
 
Hornbills, family Bucerotidae  
181. White -crested Hornbill (Berenicornis comatus) Enggang Bulu  
182. Bushy -crested Hornbill (anorrhinus galeritus) Enggang Buluh  
183. Wrinkled Hornbill (Aceros leucocephalus)  
184. Wreathed Hornbill (Aceros undulatus) Enggang Gunung  
185. Blyth's  Hornbill (Aceros plicatus) Burung Jawa  
186. Black Hornbill (Anthracoceros malayanus) Burung Gatalbirah  
187. Pied Hornbill (Antharacoceros coronatus) Burung Tangling  
188. Rhinoceros Hornbill (Buceros rhinoceros) Enggang  
189. Great Hornbill (Buceros bicornis) Enggang Papan  
190. Helmeted Hornbill (Rhinoplax vigil) Burung Terbang Mentua  
 
Barbets, family Capitonidae  
191. Fire -tufted Barbet (Psilopogon pyrolophus) Burung Tekukur Akar  
192. Lineated Barbet (Megalaima zeylanica) Tanau Rhu  
193. Gold -whiskered  Barbet (Megalaima chrysopogon) Takor Besar  
194. Many -coloured Barbet (Megalaima rafflesi) Burung Takor  
195. Gaudy Barbet (Megalaima mystacophanes)  
196. Golden -throated Barbet (Megalaima franklini)  
197. Muller's Barbet (Megalaima corti) Burung Takor Bukit  
198. Yellow -crowned Barbet (Megalaima henrici)  
199. Little Barbet (Megalaima australis) Tukang Besi  
200. Coppersmith Barbet (Megalaima haemacephala)  
201. Brown Barbet (Calorhampus fuliginosus)  
 
Honey -guide, family Indicaoridae  
202. Malay Honey -guide (indicator archipelagus) Musoh Lebah   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 174Woodpeckers, family Picidae  
203. Speckled Piculet (Picumnus innominatus) Pelatok Belang  
204. Rufous Piculet (Sasia abnormis) Pelatok Kechil  
205. Rufous Woodpecker (Micropternus brachyurus) Pelatok Biji Nangka  
206. Scally -bellied Woodpecker (Picus vir idanus) Pelatok  
207. Bamboo Green Woodpecker (Picus vittatus) Pelatok Hijau  
208. Black -naped Green Woodpecker (Picus canus) Pelatok Gunung  
209. Large Yellow -naped Woodpecker (Picus flavinuchus) Pelatok Besar 
Tengkok  Kuning  
210. Crimson -winged Woodpecker (Picus puniceus)  
211. Lesser Yellow -naped Woodpecker (Picus chlorolophus) Pelatok Kechil 
Tengkok  Kuning  
212. Checker -throated Woodpecker (Picus mentalis)  
213. Banded Red Woodpecker (Picus miniaceus) Pelatok Merah  
214. Golden -backed Three -toed Woodpecker (Dinopium javanense) Pelatok 
Pinang  
215. Olive -backed Three -toed Woodpecker (Dinipium rafflesi) Pelatok Rimba  
216. Pale-headed Woodpecker (Gecinulus grantia) Pelatok Buluh  
217. Fulvous -rumped Woodpecker (Meiglyptes tristis)  
218. Buff-necked Woodpecker (Meiglyptes tukki)  
219. Great Slaty Woodpecker (Mulleripicus pulv erulentus) Pelatok Kelabu  
220. White -bellied Black Woodpecker (Dryocopus Javensis) Pelatok Gajah  
221. Oriental Pygmy Pied Woodpecker (Dendrocopus canicapillus) Pelatok 
Belacan  
222. Malaysian Pygmy Pied Woodpecker (Dendrocopus moluccensis) Pelatok 
Kechil  
223. Grey -and-buff Woo dpecker (Hemicircus concretus)  
224. Bay Woodpecker (Blythipicus pyrrhotis)  
225. Marron Woodpecker (Blythipicus ribiginosus) Pelatok Punggor  
226. Orange -backed Woodpecker (Chrysocolaptes validus)  
227. Golden -backed Four -toed Woodpecker (Chrysocolaptes lucidus)  
 
Broadbills, fam ily Eurylaimidae  
228. Green Broadbill (Calyptomena viridis) Burung Takau  
229. Long -tailed Broadbill (Psarisomus dalhousiae) Burung Hujan -hujan  
230. Black -and-red Broadbill (Cybirhynchus macrorhynchos) Burung Rakit  
231. Silver -breasted Broadbill (Serilophus lunatus) Burung Tad a Hujan  
232. Black -and-yellow Broadbill (Eurylaimus ochromalus)  
233. Banded Broadbill (Eurylaimus javanicus)  
234. Dusky Broadbill (Corydon sumtranus)  
 
Pittas, family Pittidae  
235. Giant Pitta (Pitta caerulea) Burung Pachat  
236. Garnet Pitta (Pitta granatina) Burung Pachat Kepala Merah  
237. Blue-tailed Pitta (Pitta guajana) Burung Pachat ekor Biru  
238. Blue -winged Pitta (Pitta brachyura) Pechat Sayap Biru  
239. Hooded Pitta (Pitta sordida) Burung Gembala Pelandok   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 175Swallows and martins, family Hirundinidae  
240. House Martin (Delichon urbic a) 
241. Barn Swallow (Hirundo rustica)  
242. Pacific Swallow (Hirundo tahitica)  
243. Red -rumped Swallow (Hirundo striolata) Layang -layang Gua  
 
Minivets and greybirds, family Campephagidae  
244. Hook -billed Greybird (Tephrodornis gularis) Merbah Rimba  
245. Wh ite-vented Greybird (Coracina novaehollandiae)  
246. Barred Greybird (Coracina striata) Punai Rimba  
247. Lesser Greybird (Coracina fimbriata)  
248. Black -winged Flycatcher -shrike (Hemipus hirundinaceus)  
249. Bar -winged Flycatcher -chrike (Hemipus picatus)  
250. Pied Triller (Lalage nigra) Kuang Kuit  
251. Ashy Minivet (Percrocotus roseus) Burung Chok Padang  
252. Mountain Minivet (Pericrocotus solaris) Burung Mata Hari  
253. Fiery Minivet (Pericrocotus igneus)  
254. Scarlet Minivet (Pericrocotus flammeus)  
 
Bulbuls, family Pycnonotidae  
255. Crested Brown Bulbul (Pycnonotus eutilotus)  
256. Black -and-white Bulbul (Pycnonotus melanoleucos) Merbah Tandok  
257. Black -headed Bulbul (Pycnonotus atriceps) Burung Siam  
258. Black -crested Yellow Bulbul (Pycononotus dispa r) Merbah Kunyit  
259. Scaly -breasted Bulbul (Pycnonotus squamatus) Merbah Bersisik  
260. Grey -bellied Bulbul (Pycnonotus cyaniventris)  
261. Golden -vented Bulbul (Pycnonotus cafer)  
262. Stripe -throated Bulbul (Pycnonotus findlaysoni)  
263. Large Olive Bulbul (Pycnonotus plumosus) Murai Rimba  
264. Red -eye Brown Bulbul (Pycnonotus brunneus)  
265. White -eyed Brown Bulbul (Pycnonotus simplex)  
266. Lesser Brown Bulbul (Pycnonotus erthrophthalmus)  
267. Scrub Bulbul (Criniger bres) Burung Rabah  
268. Crested Bulbul (Cr iniger ochraceus) Merbah Berjanggut  
269. White -throated Bulbul (Criniger phaeocephalus)  
270. Finsch's Bulbul (Criniger finschi)  
271. Hairy -backed Bulbul (Hypeipetes criniger)  
272. Crested Olive Bulbul (Hypsipetes charlottae)  
273. Mountain Streaked Bulbul (Hypsipetes moclellandi) Burung Barau Bukit  
274. Streaked Bulbul (Hypsipetes viridescens)  
275. Ashy Bulbul (Hypsipetes flavalus) Burung Tuar  
 
Leafbirds and Fairy Bluebird, family Irenidae  
276. Green Iora (aegithina viridissima)  
277. Common Iora (Aegithina tiphia) Kelichap Kunyet  
278. Great Iora (aegithina lafresnayei)  
279. Lesser Green Leafbird (Chloropsis cyanopogon) Burung Daun Besar   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 176280. Greater Green Leafbird (Chloropsis sonnerati) Burung Daun Kechil  
281. Yellow -headed Green Leafbird (Chloropsis cochinc hinensis)  
282. Hardwick's Leafbird (Chloropsis hardwicki)  
283. Fairy Bluebird (Irena puella) Murai Gajah  
 
Drongos, family Dicruridae  
284. Crow -billed Drongo (Dicrurus annectans) chechawi  
285. Ashy Drongo (Dicrurus leucophaeus)  
286. Bronzed Drongo (Dicrurus  aeneus) Burung Paha Kelati  
287. Lesser Racket -tailed Drongo (Dicrurus remifer) Burung Chawi Chawi  
288. Large Racket -tailed Drongo (Dicrurus paradiseus) Burung Cha Hamba Kera  
 
Orioles, family Oriolidae  
289. Black -naped Oriole (Oriolus chinensis) Burung Kun yet Besar  
290. Indian Black -headed Oriole xanthornus)  
291. Malaysian Black -headed Oriole (Oriolus xanthonotus) Burung Kunyet Kechil  
292. Black -and-crimson Oriole (Oriolus cruentus)  
 
Crows and jays, family Corvidae  
293. Crested Malay Jay (Platylophus galericulatus) Burung Menjerit  
294. Green Magpie (Kitta chinensis) Burung Gagak Gunung  
295. Racket -tailed Magpie (Dendrocitta temia)  
296. Black -Crested Magpie (Platysmurus leucopterus) Burung Kambing  
 
Titmice, family Paridae  
297. Great Tit (Parus major)  
298. Sultan Tit (Melanochlora sultanea) Serai -serai  
 
Nuthatches, family Sittidae  
299. Velvet -fronted Nuthatch (Sitta frontalis)  
300. Blue Nuthatch (Sitta azurea)  
 
Flycatchers, family Muscicapidae  
301. Whtie -throated Fantail Flycatcher (Rhipidura albicollis) Merbah Gila Gunung  
302. Spotted Fantail Flycatcher (Rhipidura perlata)  
303. Pied fantail Flycatcher (Rhipidura javanica) Merbah Gila  
304. Grey -headed Flycatcher (Culicicapa ceylonensis)  
305. Verditer Flycatcher (Muscicapa thalassina)  
306. Blue -and-white Fl ycatcher (Muscicapa cyanomelana)  
307. Niltava (Muscicapa grandis) Burung Kubung Padi  
308. Siberian Flycatcher (Muscicapa sibirica)  
309. Ferruginous Flycatcher (Muscicapa ferruginea)  
310. Brown Flycatcher (Muscicapa latirostris)  
311. Blue -and-orange Flycatcher (Muscicapa sundara)  
312. White -tailed Blue Flycatcher (Muscicapa concreta)  
313. Pale Blue Flycatcher (Muscicapa unicolor)  
314. Blue -throated Flycatcher (Muscicapa rubeculoides)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 177315. Malaysian Blue Flycatcher (Muscicapa turcosa)  
316. Mangrove Blu e Flycatcher (Muscicapa rufigastra)  
317. Tickell's Blue Flycatcher (Muscicapa tickellae) Kelichap Ranting  
318. Hill Blue Flycatcher (Muscicapa banyumas)  
319. Pygmy Blue Flycatcher (Muscicapa hodgsoni)  
320. Rufous -breasted Blue Flycatcher (Muscicapa hyperyt hra) 
321. Mugimaki Flycatcher (Muscicapa mugimaki)  
322. Orange -breasted Flycatcher (Muscicapa dumetoria)  
323. Narcissus Flycatcher (Muscicapa narcissina)  
324. Little Pied Flycatcher (Muscicapa westermanni)  
325. White -throated Flycatcher (Muscicapa solitari s) 
326. Olive -backed Jungle Flycatcher (Rhinomyias olivacea)  
327. Whiter -throated Jungle Flycatcher (Rhinomyias umbratilis)  
328. Chestnut -winged Flycatcher (Philentoma pyrrhoptera)  
329. Maroon -breasted Flycatcher (Philentoma velata) Merbah Batu  
330. Black -naped Blue Flycatcher (Hypothymis azurea)  
331. Paradise Flycatcher (Terpsiphone paradisi) Murai Ekor Gading  
332. Japanese Paradise Flycatcher (Terpsiphone atrpcaudata) Murai  
333. Magrove Whistler (Pachycephala cinerea) Murai Bakau  
 
Bablers, family Timaliid ae 
334. Rail Babler (Eupetes macrocerus) Burung Gembala Kera  
335. Striped Babler (Pellorneum ruficeps)  
336. Black -capped Babler (Pellorneum capistratum)  
337. Tickell's Jungle Babbler (Trichastoma tickellae)  
338. Short -tailed Babbler (Trichastoma malaccensis)  
339. Blyth's Jungle Babbler (Trichastoma rostratum) BurungTelanjor  
340. Ferruginous Babbler (Trichastoma bicolor)  
341. Horsfield's Jungle Babbler (Trichastoma Sepiaria)  
342. Abott's Jungle Babbler (Trichastoma abbotti) Murai Belukar  
343. Great er Red -headed Tree Babbler (Malacopteron magnum) Murai Rimba  
344. Lesser -Red-headed Tree Babbler (Malacopteron cinereum) Burung Tua Pulih  
345. Brown -headed Tree Babbler (Malacopteron magnirostre)  
346. Plain Babbler (Malacopteron affine)  
347. White -throated  Babbler (Malacopteron albogulare)  
348. Chestnut -backet Scimirtar Babbler (Pomatorhinus montanus)  
349. Large Scimitar Babbler (Pomatorhinus hypoleucos)  
350. Striped Wren Babbler (Kenopia striata)  
351. Marbled Wren Babbler (Napothera marmorata)  
352. Large -footed Wren Babbler (Napothera macrodactyla)  
353. Streaked Wren Babbler (Napothera brevicaudata)  
354. Small Wren Babbler (Napothera epilepidota)  
355. Pygmy Wren Babbler (Pneopyga pusilla) Burung Resam  
356. Striped Tit Babbler (Macronus gularis) Merbah Sampa h Kuning  
357. Fluffy -backed Tit Babbler (macronus ptilosus) Burung Pong -pong  
358. Grey -throated Tree Babbler (Stachyris nigriceps)  
359. Grey -headed Tree Babbler (Stachyris poliocephala)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 178360. Black -necked Tree Babbler (Stachyris nigricollis)  
361. White -eared Tree Babbler (Stachyris leucotis) Kelichap Bunga Kantan  
362. Red -rumped Tree Babbler (Stachyris maculata)  
363. Red -winged Tree Babbler (Stachyris erytroptera)  
364. Hume's Tree Babbler (Stachyris rufifrons)  
365. Golden Tree Babbler (Stachyris chrysea) Kelichap Mas  
366. Black Laughing Thrush (Garrulax lugubris)  
367. Chestnut -capped Laughing Thrust (Garrulax mitratus)  
368. Red -headed Laughing Thrush (Garrulax erythrocephalus)  
369. Silver -eared Mesia (leiothrix argentauris)  
370. Cutia (Cutia nepalensis)  
371. Red -winged Shrike Babbler (Pteruthius erythropterus)  
372. Black -eared Babbler (Pteruthius melanotis)  
373. Chestnut -headed Nun Babbler (Alcippe castaneiceps)  
374. Mountain Nun Babbler (Alcippe nipalensis)  
375. Common Nun Babbler (Alcippe poiocephala) Mur ai Sampah  
376. Chestnut -tailed Siva (Minla strigula)  
377. Blue -winged Siva (Minla cyanouroptera)  
378. White -bellied Crested Babbler (Yuhina zantholeuca) Kelichap Berjambul  
379. White -headed Babbler (Gamsorhynchus rufulus)  
380. Long -tailed Sibia (Heterophas ia picaoides)  
 
Warblers, family Sylviidae  
381. Fly -eater (Gerygone fusca) Kelichap Perepat  
382. Streaked Fantail Warbler (Cisticola juncidis) Burung Laki Padi  
383. Lesser Brown Wren Warbler (Prinia rufescens)  
384. Yellow -bellied Wren Warbler (Prinia flaviv entris)  
385. White -breasted Hill Warbler (Prinia atrogularis)  
386. Pallas' Grasshopper Warbler (Locustella certhiola)  
387. Streaked Grasshopper Warbler (Locustella lanceolata) Burung Tikus  
388. Great Reed Warbler (acrocephalus arundinaceus)  
389. Green Leaf  Warbler (Phylloscopus trivirgatus)  
390. Arctic Leaf Warbler (Phylloscopus borealis)  
391. Yellow -browed Leaf Warbler (Phylloscopus inornatus)  
392. Crowned Leaf Warbler (Phylloscopus occipitalis)  
393. Chestnut -headed Flycatcher Warbler (Seicercus castanicep s) 
394. Yellow -breasted Flycatcher Warbler (Seicercus montis)  
395. White -throated Flycatcher Warbler (Seicercus superciliaris) Kelichap Buluh  
396. Ashy -naped Tailor Bird (Orthotomus cucullatus)  
397. Black -necked Tailor Bird (Prthotomus atrogularis) Kelicha p Puchat Pisang  
398. Long -tailed Tailor Bird (Orthotomus sutorius)  
399. Red -tailed Tailor Bird (Orthotomus sericeus)  
400. Red -headed Tailor Bird (Orthotomus sepium)  
 
Thrushes, family Turdidae  
401. Siberian Blue Robin (Luscinia cyane)  
402. Red -headed Robin (Luscinia ruficeps)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 179403. White -tailed Blue Robin (Muscisylvia leucura)  
404. Lesser Shortwing (Brachypteryx leucophris)  
405. Orange -tailed Shama (Copsychus pyrropygus)  
406. Common Shama (Copsychus malabaricus) Murai Batu  
407. White -crowned Forktail (Enicuru s leschenaulti)  
408. Chestnut -naped Forktail (Enicurus ruficapillus) Burung Chegar  
409. Slaty -backed Forktail (Enicurus schistaceus) Burung Chegar Besar  
410. Stone Chat (Saxicola torquata)  
411. White -throated Rock Thrush (Monticola gularis)  
412. Blue -Rock Thrush (Monticola Solitaria) Burung Tarom  
413. Grey -headed Thrush (Turdus obscurus) Murai Belanda  
414. White's Ground Thrush (Zoothera dauma)  
415. Siberian Ground Thrush (Zoothera sibirica)  
416. Orange -headed Ground Thrush (Zoothera citrina)  
417. Chestnut -headed Ground Thrush (Zoothera interpres)  
418. Blue Whistling Thrush (Myiophoneus coeruleus) Tiong Belachan  
419. Malayan Whistling Thrush (Myiophoneus robinsoni)  
 
Wagtails and pipits, family Motacillidae  
420. Grey Wagtail (Motacilla cinerea) Mentua Pelando k 
421. Pied Wagtail (Motacilla alba)  
422. Yellow Wagtail (Motacilla flava)  
423. Forest Wagtail (Motacilla indica)  
424. Tree Pipit (Anthus hodgsoni)  
425. Richard's Pipit (Anthus novaeseelandiae) Burung Apit -apit 
 
Shrikes, family Laniidae  
426. Schach Shrike (Lanius schach)  
427. Brown Shrike (Lanius cristatus)  
428. Thick -billed Shrike (Lanius tigrinus) Burung Tirjup  
 
Flowerpeckers, family Dicaeidae  
429. Scarlet -backed Flowerpecker (Dicaeum cruentatum) Burung Sepah Putri  
430. Javan Fire -breasted Flowerpecker (D icaeum sanguinolentum) Burung  Sepah 
Putri Gunung  
431. Orange -bellied Flowerpecker (Dicaeum trigonostigmum)  
432. Yellow -vented Flowerpecker (Dicaeum chrysorrheum)  
433. Plain Flowerpecker (Dicaeum concolor)  
434. Crimson -breasted Flowerpecker (Prionochilus percussus)  
435. Scarlet -breasted Flowerpecker (Prionochilus throcicus)  
436. Yellow -throated Flowerpecker (Prionochilus maculatus)  
437. Hume's Flowerpecker (Dicaeum modestum)  
438. Thick -billed Flowerpecker (Dicaeum agile)  
 
Sunbirds and spiderhunters, family  Nectariniidae  
439. Plain -coloured Sunbird (Anthreptes Simplex)  
440. Brown -throated Sunbird (Anthreptes malacensis) Kelichap Mayang Kelapa   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 180441. Rufous -throated Sunbird (Anthreptes rhodolaema)  
442. Ruby -cheeked Sunbird (Anthreptes singalensis) Kelichap Belu kar 
443. Purple -naped Subird (Nectarinia hypogrammica) Kelichap Rimba  
444. Van Hasselt's Sunbird (Nectarinia sperata)  
445. Macklot's Sunbird (Nectarinia chalcostetha)  
446. Yellow -breasted Sunbird (Nectarinia jugularis)  
447. Black -breasted Sunbird (Aethopyg a saturata)  
448. Yellow -backed Sunbird (Aethopyga siparaja)  
449. Scarlet Sunbird (Aethopyma mystacalis)  
450. Little Spiderhunter (Arachnothera longirostris) Kelichap Jantong  
451. Thick -billed Spiderhunter (Arachnothera crassirostris)  
452. Long -billed Spide rhunter (Arachnothera robusta)  
453. Greater Yellow -eared Spiderhunter (Arachnothera flavigaster)  
454. Lesser Yellow -eared Spiderhunter (Arachnothera chrysogenys) Kelichap 
Pisang  
455. Grey -breasted Spiderhunter (Arachnothera affinis)  
456. Streaked Spiderhun ter (Arachnothera magna)  
 
White -eye, family Zosteropidae  
457. Oriental White -eyed (Zosteropidae palpebrosa) Kelichap Kunyet  
 
Starling, family Sturnidae  
458. Daurian Starling (Sturnus sturninus)  
459. Chinese Starling (Sturnus sinensis)  
460. Gold -crested Myna (Ampeliceps coronatus)  
461. Chinese Crested Myna (Acridotheres cristatellus)  
 
Sparrows and finches, family Ploceidae  
462. Pin -tailed Parrot Finch (Erythrura prasina) Chiak Perut Merah  
463. Bamboo Parrot Finch (Erythrura hyperthra)  
464. Brown Bulfinch (Pyrrhula nipalensis) Pipit Gunung  
465. Yellow -breasted Bunting (Emberiza aureola)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 18112.3 SPECIFIC INGREDIENTS NOT ALLOWED TO BE REGISTERED UNDER  
TRADITIONAL MEDICINE  
 
a. HUMAN PART  
Traditional products are prohibited from cont aining ingredients derived from 
human.  
Example:  
i. CRINIS CARBO NISATUS = Carbonised human hair  
(Ref: Pharmacopoeia Of The People’s Rep ublic Of China: English Edition 
1992)  
ii. HUMAN PLACENTA  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 18212.4 LABELLING REQUIREMENTS FOR TRADITIONAL PRODUCTS  LABEL 
AND PACKAGE INSERT  
i. All labels and package inserts must be in B. Malaysia or English. Translation 
to another  language is allowed.  
ii. Please ensure all items indicated are stated on the labels and package 
inserts.  
 State the weight per tablet/ca psule/caplet/pill/bottle (ml/L)  
 State the quantity / content of active ingredients  per 
tablet/capsule/pill/caplet  
 For products in liquid form (syrup), content of active ingredients should 
be stated as  follows:  
“Each ____ml product contains extract of the f ollowing ingredients”  
Herb X = ___mg  
Herb Y = ___mg  
 Check and correct all spelling/grammar and translations  
 For changes and amendments, submit label and package insert draft 
with the  changes clearly indicated.  
 
ADD ITIONAL STATEMENT TO BE PRINTED * 
 If sympto ms persist, please consult a doctor.  
 This is a traditional medicine. /Ini adalah ubat tradisional. ATAU This is a  
homeopathy medicine/ Ini adalah ubat homeopati  
 Keep out of reach of children & Jauhi dari kanak -kanak (in both Bahasa 
Malaysia  and English).  
 For products containing animal part(s) , please add this statement: This 
product  contains animal part(s).  
 For products containing animal origin(s) , please add this statement: This 
product  contains substance(s) from animal origin.  
 For products containing porcine, please add this statement: This product 
contains  animal part(s) (porcine/pig).  
 For products containing alcohol , this statement needs to be stated: This 
product  contains alcohol .  
Please declare the percentage of alcohol contained in the product.  
 Keep  in a cool dry place.  
 For external use only  (for topical preparations)  
 Shake well before use  (for liquids and suspensions)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 183 For products containing CAMPHOR , the following warning should be stated 
on the label:  






PRECAUTION: ‘It is dangerous to place any camphor – containing 
productinto the nostril of children. A small amount applied this  way may 
cause  immediate collapse’  
- Avoid contact with the eyes  
- Do not apply to wounds or damaged skin 
 
 For products containing GINSENG (including all PANAX genus) state:  
- Safe use of ginseng in pregnant women and children has not been  
established.  
- Do not ex ceed the stated dose  
- Safety on long te rm use has not been established  
 For products containing BEE POLLEN , state:  
- This product contains Bee Pollen and may cause severe allergic  
reactions, including fatal anaphylactic reactions in susceptible  individuals.  
- Asthma and allergy sufferers may be at greater risks.  
 For product containing CHELIDONIUM MAJUS , state (IN TWO 
LANGUAGES):  
- Warning: This Product may cause adverse reaction to the liver.  
- Amaran: Produk ini mungkin boleh menyebabkan kesan sampingan  pada 
hepar  (hati)  
 For product containing SENNA LEAF (CASSIA) and RHUBARB/RADIX et 
RHIZOMA RHEI , state:  
- Do not use when abdominal pain, nausea or vomiting is present.  
- Frequent or prolonged used of this preparation may result in dependence  
towards the product and ‘imbalanced electrolytes’.  
 For product containing ALFALFA (Medicago sativa) , state:  
Text Box: This product contains Alfalfa (Medicago sativa).  
Individuals with a predisposition to systemic lupus erythematosus should  
consult their physician before consuming  this product.  CAN CAUSE CONVULSION  
CONTRAINDICATED IN INFA NTS BELOW 2 YEARS OF AGE  
CAUTION MUST BE EXERCISED WHEN OLDER CHILDREN ARE  
TREATED  
AVOID DIRECT APPLICATION INTO NOSTRILS  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 184 For product containing BLACK COHOSH ( Cimicifuga racemosa ), state:  
Warning:  
- Stop taking this product if signs and symptoms suggestive  of liver 
injury develop such as tiredness, loss of appetite,  yellowing of the skin 
and eyes or severe upper  stomach  pain with nausea and vomiting or 
dark urine and consult  your doctor immediately.  
- Patients using herbal medicinal products should tell their  doctor about 
it. 
 
 For product containing ST. JOHN’S WORT , state  
 
                 The product may interact  with other medicines.  
Please consult a doctor / pharmacist before  
using it.  
 
 For product  containing  Pelargonium sidoides , state:  
 
 
In very rare cases, pelargonium sidoides  
may cause hypersensitivity reactions  
 
 
 For product containing Benzyl Alcohol/ Phenylmethanol  (as preservative), 
state:  
 
 
As this preparation containing Benzyl Alcohol,  
 its use should be avoided in children under 2  
years  of age. Not to be used in neonates  
 
 
 For product contraining  Ginkgo biloba / Ginkgo extract , state:  
- As the use of Ginkgo may increase the tendency of bleeding, please 
consult your physician/  pharmacist if you  are on or intend to start using 
any other medicines and before you undergo any surgical/dental 
procedure.  
- (Memandangkan Ginkgo boleh meningkatkan kemungkinan 
pendarahan, sila rujuk kepada doktor/ ahli farmasi sekiranya anda 
sedang atau sedang akan menggunakan ubat lain dan sebe lum 
prosedur pembedahan/ dental  dijalankan.  
 
 For product cont aining  substance from seafood , state:  
- Derived from seafood.  
 
 For product co ntaining royal jelly , state:   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 185- This product contains royal jelly and may cause  severe allergic 
reactions including fatal anaphylactic reactions in susceptible 
individuals.  
- Asthma and allergy sufferers may be at the greater risk.  
 
 For product cont aining Propolis (topical preparation) , state:  
- Propolis may cause allergic skin reaction.  
 
 For product cont aining ‘Anti -diarrhoea’ , state:  
- Contraindicated in children below 1 year old . 
 
 For product with indication ‘ To regulate menstruation / to improve menstrual 
flow’, state:  
- Contraindicated in pregnant women .  
 
 For product with indication ‘ To reduce body weight’ , state:  
- Balanced diet and regular exercise are essential .  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 186LABELLING REQUIREMENT  
 
 
ITEMS   
IMMEDIATE 
LABEL   
OUTER 
LABEL   
PACKAGE 
INSERT   
BLISTER 
PACK  
Product name and dosage form  
     
Active ingredients / content and 
quantity (mcg or g)  
     
Name and strength/concentration of 
preservative (liquid preparation only)  
     
To declare source of ingredients 
derived from animal origin, including 
gelatine (active, excipient, and/ or 
capsule shell)      
Indication (use the proposed 
indication)  
     
Expiry date  
     
Batch number  
     
Manufacturing date  
     
Name and address of Marketing 
Authorization Holder      
Name and address of manufacturer  
     
Name and address of repacker  
     
Registration number (MAL)  
     
Storage condition  
     
Dosage and administration  
     
Recommended usage  
     
Instruction/additional statement (if 
any) 
     
Parts of plant used  
      
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 187Alcohol content (if any)      
Warning label  
a. Ginseng  
b. Bee pollen  
c. Senna leaf (Cassia) and 
Rhubarb/radix or Rhizoma Rhei  
d. Camphor  
e. Chelidonium majus  
f. Alfalfa ( Medicago sativa ) 
g. St. John’s Wort  
h. Black cohosh  
i. Propolis  
j. Royal jelly  
k. Ginkgo biloba / Ginkgo extract  
l. Pelargonium sidoides  
m. Benzyl Alcohol / 
Phenylmethanol (preservative)  
n. Substance from seafood      
Contraindication/Precaution (if any)  
     
Packaging size  
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 18812.5 INDICATIONS ACCEPTABLE FOR TRADITIONAL PRODUCTS  
 
GENERAL HEALTH MAINTENANCE / KESIHATAN AM  
 
“Traditionally used…./ “Digunakan secara tradisional….  
“Digunakan secara homeopati untuk.../ “Homeopathically  used .... 
 
1. for general health  / for health / untuk kesihatan.   
2. general health maintenance / for general well be ing. 
3. for health and strengthening the body / untuk kesihatan dan menguatkan  
badan.  
4. for relief of body heatiness / untuk melegakan panas badan.  
5.  for general debility, weakness after illness or ch ildbirth / untuk letih lesu / 
kelesuan badan selepas sakit atau selepas bersalin.  
6. for loss of appetite / untuk kurang selera makan.  
7.  for difficulty in sleep / bagi melegakan kesukaran untuk tidur.  
8.  for relief of fatigue / untuk melegakan kepenat an.  
9. as an aid to overcome fatigue during physical exertion / membantu 
melegakan kepenatan fizikal.  
10. to expel wind and invigorate vita l energy / untuk membuang angin  dan 
menambah tenaga.  
11. to improve appetite / untuk menambah selera makan.  
12.  for relieving waist ache and body weakness / untuk melegakan sakit pinggang 
dan lemah anggota badan.  
13.  for relieving dizziness, sweating, and difficulty in sleep / untuk melegakan 
pening, berpeluh berlebihan dan sukar untuk tidur.  
14.  for reducing bod y odour / untuk mengurangkan bau badan.  
15.  for reducing toothache / untuk mengurangkan sakit gigi.  
16.   to relieve tired eyes/ untuk  melegakan kepenatan mata.  
17. for healthy eyes/ untuk kesihatan mata  
 
 
BLOOD & BODY FLUID / DARAH & CECAIR BADAN   
 
“Traditionally used…./ “Digunakan secara tradisional….  
 
1.  for improving blood circulation / untuk melancarkan perjalanan darah.  
2.  to improve urination / untuk melawaskan kencing / buang air kecil.  
3.  for improving bowel movement / untuk melawaskan b uang air besar.  
4.  for relieving mild vomiting / untuk melegakan muntah ringan.  
5.  for reducing minor swelling / untuk melegakan bengkak -bengkak ringan.  
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 189BONE, MUSCLE AND JOINT / TULANG, OTOT & SENDI   
 
“Traditionally used…./ “Digunakan secara trad isional….  
 
1.  for strengthening muscle and bone / untuk menguatkan otot dan tulang.  
2.  for relieving muscular ache / untuk melegakan sakit otot.  
3.  for relieving waist ache and backache /  untuk melegakan sakit pinggang 
 dan sakit belakang.  
4.  for re lief of joints and muscular pain / untuk melegakan sakit sendi dan otot.  
5. for relieving muscles sprain / untuk melegakan terseliuh / terkehel.  
 
 
PAIN & FEVER / SAKIT AM & DEMAM   
 
“Traditionally used…./ “Digunakan secara tradisional….  
 
1.  to relieve / alleviate pain / untuk melegakan kesakitan.  
2.  for relieving fever / untuk melegakan demam.  
3.  for relieving headache / untuk melegakan sakit kepala.  
4.  for relieving pain and itchiness related to piles / untuk melegakan kesakitan 
dan ra sa gatal akibat buasir.  
5.  for symptomatic relief of body heatiness / body heat / untuk melegakan panas 
badan.  
 
 
COUGH & COLD / BATUK & SELSEMA   
 
“Traditionally used……/ “Digunakan secara tradisional…..  
 
1.  for relief of fever, cough and cold / u ntuk m elegakan demam, batuk dan 
selsema.  
2.  for relief of sore throat / untuk melegakan sakit tekak.  
3.  for reducing phlegm and relief of cough, sore throat and body heatiness / 
untuk mengurangkan kahak dan melegakan batuk, sakit tekak dan panas 
badan.  
4.  for relief of throat irritations and cough / untuk melegakan sakit tekak dan 
batuk.  
5.  for relief of nasal congestion / untuk melegakan hidung tersumbat.  
6. for relief of sore throat and cough / untuk melegakan sakit tekak dan batuk.  
7.  for relief of mouth ulcers due to heatiness / untuk melegakan sakit mulut 
akibat panas badan.  
8. to relieve sinusitis/ untuk melegakan resdung  
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 190DIGESTIVE SYSTEM / SISTEM PENCERNAAN   
 
“Traditionally used…./ “Digunakan secara tradisional….  
 
1.  for relief of stomach ache, mild diarrhoea / untuk melegakan sakit perut,  
           cirit-birit ringan.  
2.  for relief of flatulence, stomach ache, mild diarrhoea, and loss of appetite / 
untuk melegakan kembung perut, sakit perut, cirit -birit ringan dan  kurang 
selera makan.  
3.  for relief of mild diarrhoea, vomiting and improve appetite / untuk melegakan 
cirit-birit, muntah ringan dan menambah selera makan.  
4.  for relief of mild constipation / untuk melegakan sembelit ringan.  
5.  to improve appetite and digestion / untuk menambah selera makan dan 
pencernaan.  
6. for relieving abdominal pain and flatulence / untuk melegakan sakit perut dan 
kembung perut.  
7.  for relief of stomach ache, constipation, mild vomiting and indigestion / untuk 
melegakan saki t perut, sembelit, muntah ringan dan makanan tidak hadzam.  
8.  aid in digestion / untuk membantu penghadzaman.  
 
 
WOMEN’S HEALTH / KESIHATAN WANITA  
 
“Traditionally used…../ “Digunakan secara tradisional….  
 
1.  to relieve menstrual pain, headache and to regulate menstruation / untuk 
melegakan senggugut, sakit kepala dan melancarkan perjalanan haid.  
2.  to reduce body weight / untuk mengurangkan berat badan.  
3.  for relief of vaginal discharge / untuk melegakan keputihan.  
4.  for women after childbirth / untuk wanita lepas bersalin.  
5.  for general wellbeing and strengthen the body after childbirth / untuk 
kesihatan dan menguatkan badan wanita selepas bersalin.  
6.  for women after childbirth to reduce body weight / untuk ibu -ibu selepas 
bersalin untuk mengurangkan berat badan.  
7.  for symptomatic relief of vaginal discharge and mild itch / untuk melegakan 
keputihan dan gatal -gatal ringan.  
8.  to improve menstrual f low, for relief of menstrual pain, vaginal discharge and 
flatulence / untuk melancarkan haid, melegakan senggugut, keputihan dan 
kenbung perut.  
9.  for strengthening body muscle and reducing body weight / untuk 
mengencangkan otot -otot tubuh dan mengurangk an berat badan.  
10.  for general health of women after childbirth / untuk menyihatkan rahim 
selepas melahirkan anak.  
11. to relieve symptoms of menopause./ untuk melegakan simptom menopause. 
(for specific active ingredient only, examples: Red clover (Tri folium pratense) 
and Black cohosh ( Cimicifuga racemosa ) 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 191MEN’S HEALTH / KESIHATAN LELAKI  
 
“Traditonally used…./ “Digunakan secara tradisional….  
 
1.  for energy and men’s health / for vitality / untuk memulihkan tenaga dan  
           kesihatan lelaki.  
 
 
KULIT DAN KEGUNAAN LUAR  
 
“Traditionally used…../ “Digunakan secara tradisional…  
  
1.  for symptomatic relief of pain and itch associated with insect bites / untuk 
melegakan sakit dan gatal -gatal digigit serangga.  
2.  for relief of minor burns / untuk mel egakan melecur ringan.  
3.  for relief minor cuts / untuk melegakan luka -luka ringan.  
4.  or relief of minor bruises / untuk melegakan lebam yang ringan.  
5.  for reducing pimples / untuk mengurangkan jerawat.  
6.  to help maintaining healthy skin, nail and hair / untuk kesihatan kulit, kuku  
           dan rambut.  
7.  for reducing pimples and mild itch / untuk melegakan jerawat dan gatal -   
           gatal ringan.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 19212.6 QUALITY CONTROL TEST SPECIFICATIONS FOR TRADITIONAL  
MEDICINE PRODUCTS  
 
1.  Limit Test for Heavy Metals  
Maximum limit for heavy metals:  
1.1 Lead  : NMT 10.0 mg/kg or 10.0 mg/litre (10.0ppm)  
1.2 Arsenic  : NMT 5.0 mg/kg or 5.0 mg/litre (5.0ppm)  
1.3 Mercury  : NMT 0.5 mg/kg or 0.5 mg/litre (0.5ppm)  
1.4 Cadmium  : NMT 0.3 mg/kg or 0.3 mg/litre (0.3ppm)  
 
2.  Disintegration Test (for tablets, capsules and pills)  
Disintegration time  
2.1 Uncoated tablets  : NMT30 minutes  
2.2 Film-coated tablets  : NMT 30 minutes  
2.3 Sugar -coated tablets  : NMT 60 minutes  
2.4 Enteric -coated 
tablets  : Does not disintegrate for 120 minutes in acid 
solution but to disintegrate within 60 minutes in 
buffer solution  
2.5 Capsules  : NMT 30 minutes  
2.6 Pills : NMT 120 minutes  
 
3. Test for Uniformity of Weight (tablets and capsules only)  
Not more than 2 capsules / tablets exc eed the limit by ± 10% from the 
average weight  AND no tablet / capsule exceed the limit by ± 20% from the 
average weight.  
 
4. Test for Microbial Contamination  
 
 
Route of Administration   
TAMC  
(CFU/g or CFU/ ml)   
TYMC  
(CFU/g or CFU/ ml)   
Test for Specified 
Microorganisms  
 
Rectal Use   
NMT 2 x 103 
  
NMT 2 x 102  
 
Oromucosal Use  
Gingival Use  
Cutaneous Use  
Nasal Use  
Auricular Use  
  
 
 
NMT 2 x 102 
  
 
 
NMT 2 x 101  
- Absence of Staphylococcus 
aureus  in 1g or 1ml  
 
- Absence of Pseudomonas 
aeruginosa in 1g or 1ml  
 
 
Vaginal Use  
  
NMT 2 x 102 
  
NMT 2 x 101 
  
- Absence of Staphylococcus 
aureus in 1g or 1ml   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 193 
- Absence of Pseudomonas 
aeruginosa in 1g or 1ml  
 
- Absence of Candida albicans in 
1g or 1ml  
 
 
Transdermal Patches (limits 
for one patch including 
adhesive layer and backing)  
  
NMT 2 x 102 
  
NMT 2 x 101 
  
- Absence of Staphylococcus 
aureus  in 1 patch  
 
- Absence of Pseudomonas 
aeruginosa in 1 patch  
 
 
Inhalation Use (Special 
Requirement apply to liquid 
preparations for 
nebulisation)  
  
NMT 2 x 102 
  
NMT 2 x 101 
  
- Absence of Staphylococcus 
aureus in 1g or 1ml  
 
- Absence of Pseudomonas 
aeruginosa in 1g or 1ml  
 
- Absence of bile -tolerant gram -
negative bacteria in 1g or 1ml  
 
 
Special Ph. Eur. provision 
for oral dosage forms 
containing raw materials of 
natural (animal, vegetal or 
mineral) origin for which 
antimicrobial pretreatment is 
not feasible and for which 
the competent authority 
accepts TAMC of the raw 
material exceeding 1 03 CFU 
per gram or milliliter  
  
NMT 2 x 104 
  
NMT 2 x 102 
  
- NMT 2 x 102 CFU of bile -tolerant 
gram - negative bacteria in 1g or 
1ml 
  
- Absence of Salmonella in 10g or 
10ml  
 
- Absence of Escherichia coli in 1g 
or 1ml  
 
- Absence of Staphylococcus 
aureus in 1g or 1ml  
 
 
Special Ph. Eur. provision 
for herbal medicinal 
products consisting solely of 
one or more herbal drugs 
(whole, reduced or 
powdered):  
 
- Herbal medicinal products 
to which boiling water is 
added before use  
 
- Herbal medicinal products 
to which boiling water is not 
added before use  
  
 
 
 
 
 
 
 
NMT 2 x 107 
 
 
 
NMT 2 x 105 
 
  
 
 
 
 
 
 
 
NMT 2 x 105 
 
 
 
NMT 2 x 104 
  
 
 
 
 
 
 
 
- NMT  2 x 102 CFU of Escherichia 
coli in 1g or 1ml  
 
 
- NMT 2 x 103 CFU of bile -tolerant 
gram - negative bacteria in 1g or 
1ml 
  
- Absence of Escherichia coli in 1g 
or 1ml   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 194 
- Absence of Salmonella in 10g or 
10ml  
 
TAMC  : Total Aerobic Microbial Count  
TYMC  : Total Yeasts & Moulds Count  
NMT  : Not more than  
 
Reference: British Pharmacopoeia 2009   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 19512.7   GARISPANDUAN UNTUK VISUAL /GRAFIK BAGI LABEL PRODUK SEMULAJADI  
 
 
1. Logo kecil atau trademark yang 
mengandungi perkataan  
 Contoh: - 
ABCDTM , 1234TM  Jika logo kecil tidak perlu dimasukkan 
sebagai produk. Tetapi jika logo besar dan 
trademark/registered perlu dimasukkan 
sebagai nama produk.  
 
2. Strategi pemasaran  Contoh: - 
“Money back guarantee”  
“Buy 1 free 1”  
“Backed by RM5 million product 
Liability Insurance”  
 Tidak boleh dinyatakan pada label 
(mengikut keperluaan Akta Iklan)  
3. Cara penggunaan yang mengiklankan 
produk lain untuk diambil bersama.  Contoh: - 
‘Dicadangkan selepas 
mengambil produk ini (produk A) 
dan untuk lebih berkesan, sila 
ambil produk B’  
 Boleh dengan syarat semua produk 
tersebut mesti berdaftar.  
4. Testimonial pengguna   Tidak boleh dinyatakan pada label.  
 
5. Keputusan Clinical Trial pada label 
atau sebarang maklumat tentang 
clinical trial yg dijalankan terhadap 
bahan aktif / produk.  Contoh : - 
“Clinically Tested”  
“Randomized Double Blind 
Placebo Control Clinical Study”  
 Tidak boleh dinyatakan pada label 
(mengik ut keperluaan Akta Iklan)  
6. Gambar pengasas produk   Boleh digunakan pada label.  
 
7. Rujukan dari Hadith/ Al -Quran/ Bible/ 
buku agama dan lain -lain. 
  Tidak boleh dinyatakan pada label.  
8. Pendapat -pendapat tokoh terkemuka 
mengenai produk atau bahan aktif 
produk tersebut.  
 Contoh : - 
Pendapat dari inventor produk / 
formulasi  Tidak boleh dinyatakan pada label.  
9. Label yang hampir menyerupai label 
syarikat lain (dari segi grafik dan  Tidak boleh menggunakan label tersebut.  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 196warna)  
10. Kenyataan yang menyatakan origin 
herba  
 Contoh: - 
Diambil daripada Pergunungan 
Alps Boleh dengan syarat dapat dibuktikan.  
11. Kenyataan yang mengenalkan 
pengasas/ pengilang.   Tidak boleh dinyatakan pada label.  
 
12. Logo yang mempunyai sijil 
pengesahan.  
 Contoh : - 
SIRIM / ISO / GMP  / HACCP  Tidak boleh dinyatakan pada label kerana 
sijil tersebut  perlu diperbaharui setiap 
tahun.  
 
13. Nama/ Kenyataan / Logo/ cap 
dagangan yang berdaftar (registered / 
trademark) tetapi tidak menepati 
spesifikasi Unit Tradisional  
 Contoh: - 
“Formula Dr.ABC”  
“Tiada yang serupa dengannya”  Tidak boleh dinyatakan pada label.  
14. Patency claim/ Patency number/ 
teknik khas yang digunakan/ 
kelebihan bahan (contoh: sarung 
kapsul)  
 Contoh: - 
Patented technique   
Boleh dengan syarat dapat dibuktikan.  
15. Nutritional claim dengan sijil analisis 
disertakan.  Contoh  :- 
Calori, Fat, Protein dan lain -lain Tidak boleh dinyatakan pada label kerana 
ini adalah ubat dan bukannya makanan.  
 
16. Negative remarks  Contoh: -  
“NO ANIMAL INGREDIENT”  
“NO LAXATIVE”  
 Tidak boleh dinyatakan pada label.  
17. Gambar organ -organ dalaman  Contoh: - 
Ginjal, Jantung, Urat saraf.  Tidak boleh digunakan pada label.  
 
18. Gambar selebriti  Contoh : - 
Artis, Ahli Sukan, Ahli Politik  
 Tidak boleh digunakan pada label.  
19. Simbol jantina (lelaki atau perempuan)  (♀ dan / atau ♂) 
 Tidak boleh digunakan pada label.  
20. Gambar yang berunsur atau berbau 
lucah  
 
  Tidak boleh digunakan pada label.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 19721. Gambar yang tidak selaras dengan 
indikasi  
 Contoh: -  
- Indikasi untuk sembelit tetapi 
grafik label adalah gambar 
wanita yang mempunyai 
potongan tubuh yang langsing 
yang menggambarkan indikasi 
untuk mengurangkan berat 
badan.  
- Indikasi untuk ‘urination’ tetapi 
grafik label adalah gambar paip 
air. 
  
Tidak boleh digunakan pada label.  
22. ‘Highlight’kan bahagian tubuh yang 
tidak sepatutnya.  Contoh: - 
Indikasi general health tetapi 
grafik adalah highlight bahagian 
organ jantina lelaki atau 
perempuan.   
Tidak boleh digunakan pada label.  
23. Gambar tumbuhan atau haiwan yang 
diubahsuai atau mengelirukan  Contoh: - 
Radix Ginseng  yang diubahsuai 
menyerupai organ jantina lelaki 
dan perbuatan manusia yang 
sedang duduk.  
  
Tidak boleh digunakan pada label.  
24. Kenyataan -Kenyataan Lain  Contoh: - 
- This product is blended with 
premium quality  
- Certified chemical residue free  
 Tidak boleh dinyatakan pada label.  
 
 
English Version  
 
Appendix: 12.7 PROHIBITED VISUAL / GRAPHICS ON LABEL OF NATURAL PRODUCTS  
 
No. Issue  Example  Note  
1.  Logos or trademarks which 
contains  
letters and digits  Example:   
ABCDTM, 1234TM, Pagoda Logo 
etc. Only large logos  and 
registered trademarks need to be included 
as a product name   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 1982.  Marketing strategy  
 Example:  
“Money back guarantee”  
“Buy 1 free 1”  
“ Backed by RM5 million  
product Liability Insurance”  Such statements are  
prohibited on labels (as per Medicines 
(Advertisement  
and Sale) Act 1956  
requirements  
3.  Usage guide which promotes use of  
other product(s)  Example:  
“After consumption of  
this product (Product  
A), for better results, it is 
recommended to take  
Product B”  This is allowed if all products are 
registered with the DCA  
4.  Consumer testimonial   Prohibited on product label  
5.  Clinical Trial results or any 
information  
on clinical trial done on product  
 Example : - 
“Clinically Tested”  
“Randomized Double Blind 
Placebo Control Clinical Study”  Such statements are  
prohibited on labels (as per Medicines 
(Advertisement  
and Sale) Act 1956  
requirement  
6.  Photograph of product pioneer   Allowed to be used on  
product label  
7.  Reference to Hadith/ Al -Quran/ 
Bible/  
Religious books   Prohibited on product label  
8.  Opinion of prominent ﬁgure(s) on  
product or its active ingredient/  
content  Example:  
Opinion of product/  
formulation inventor  Prohibited on product label  
9.  Label design (graphic and color)  
similar to labels from another  
company   Prohibited on product label  
10.  Statement on herbal origin  Example:  
Source from the  
Mountains of Alps  Allowed if proven true  
11.  Introduction of founder/  
manufacturer   Prohibited on product label  
12.  Logo with certi ﬁcation  Example :  
SIRIM/ ISO / GMP /HACCP  Prohibited on product label because 
certiﬁcation renewal is on a yearly basis  
13.  Name/ Statement / Logo/registered  
trademark which does not satisfy 
the Example:  
“Dr.ABC’s Formula”  
“Nothing like it”  Prohibited on product label   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 199speci ﬁcations of the Traditional Unit  
14.  Patency claim/ Patency number/  
Special technique used/ superiority 
in 
ingredients (Example:  capsule 
coat)  Example:  
Patented technique  Allowed if proven true  
15.  Nutritional claims with analysis  
certiﬁcate attached  Example:  
Calorie, Fat, Protein and  
others  Prohibited on product label  
16.  Negative remarks  Example:  
“NO ANIMAL INGREDIENT”  
“NO LAXATIVE”  
 Prohibited on product label  
17.  Graphics or picture of internal 
organs  Example:  
Kidney, Heart, Nerves.  Prohibited on product label  
18.  Photograph of celebrities  Example:  
Artiste,  Sports person(s),  
Politician  Prohibited on product label  
19.  Sex symbol (male or female)  (♀ and / or ♂)  Prohibited on product label  
20.  Indecent photographs/ pornography   Prohibited on product label  
21.  Graphics which are incoherent with  
the indication  Example:  
- Noted indication is  
for constipation, but  
graphics on label shows  
a slim -looking lady which 
denotes indication for weight 
loss 
- Indication for urination but 
label graphics contains picture 
of a 
water hose.  
 Prohibited on product label  
22.  Highli ghting unnecessary body 
parts  Example:   
Indication is for general  
health but graphics on  
label highlights male and female 
sexual organ parts  Prohibited on product label  
23.  Graphics of plants or animal which  Example:  Prohibited on product label   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 200may cause confusion  Radix Ginseng which  is 
improvised as a male  
sexual part  
 
24.  Other statements  Example:  
- This product is blended  
with premium quality  
- Certi ﬁed chemical  
residue free  Prohibited on product label  
 
*This list is not meant to be exhaustive.  
*It may be reviewed as and when it is deemed necessary  
* DCA reserves the right to disallow any other words, phrases or graphics for product label which in  its opinion is 
misleading, improper or not factual  
 
 
 
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 20112.8   List of Non Permissible Product Name for Natural Products  
 
Bil. Perkara  Contoh  
1. Tidak dibenarkan menggunakan nama 
penyakit yang tidak boleh diiklan di 
bawah Akta Ubat (Iklan & Penjualan) 
1956 (Disemak 1983)  Contoh : -  
Diabetes, Asma, Kanser  
 
 
 
2 Tidak dibenarkan  menggunakan nama 
bagi satu bahan aktif sebagai nama 
produk sekiranya produk tersebut 
mengandungi beberapa bahan aktif 
kecuali ianya ditambahkan dengan 
perkataan seperti ‘Plus, Compound, 
Complex, Herbanika, Enrich  
 Contoh : - 
Kapsul Tongkat Ali   ----  
Tetapi produk  mengandungi  
Tongkat Ali , ginseng dan lain -lain 
bahan  
 
 
3 Tidak dibenarkan menggunakan nama 
superlatif  
Nama yang menunjukkan efikasi yang 
melampau  
 Contoh : - 
Power, Superior, Pure, Mustajab,  
Safe, Healthy, Penawar, VIP, 
Good  
4 Tidak dibenarkan menggunakan nama 
yang mengelirukan dari segi ejaan dan 
sebutan .  
Mengambil sebahagian /separuh dari: -  
- 20 nama penyakit yang tidak 
dibenarkan di dalam Akta Ubat 
1956 (Iklan &  Penjualan) 
(Disemak 1983)  
ii) penyakit -penyakit  lain tanpa bukti 
saintifik  
iii) indikasi yang tidak dibenarkan  
 Contoh: - 
a) Go Out = GOUT (label)  
b) Utix  
 
5 Tidak dibenarkan menggunakan nama 
yang mengelirukan dari segi maksud . 
Nama produk yang boleh dipertikaikan 
maksudnya.  
 Contoh: - 
B For Energy ?  
6 Tidak dibenarkan menggunakan nama 
yang bercanggah dengan taraf tata 
susila/ kesopanan  
Nama yang mana jika ditafsirkan akan 
bercanggah/melanggar taraf tata susila/ 
kesopanan di kalangan masyarakat 
Malaysia  
 Contoh: - 
SENXBIG=SEnXBIG(label)  
Sexy,Enjoy,Parad ise,Heavenly,  
Blue boy,Casanova, Desire  
 
 
7 Tidak dibenarkan menggunakan nama 
produk yang tidak selaras dengan 
indikasi yang dipohon  
Nama produk memberi gambaran untuk 
satu indikasi tetapi sebenarnya terdapat Contoh: - 
Ubat Batuk X= Indikasi yang 
dipohon pula adalah untuk batuk, 
pening kepala,selsema dan 
kegatalan.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 202beberapa indikasi yang dipohon.  
  
    8. Tidak dibenarkan menggunakan nama 
produk yang membawa maksud 
kepercayaan karut   
Kenyataan –kenyataan yang merujuk 
kepada bahan -bahan purbakala / ma khluk 
halus / kuasa -kuasa luarbiasa   Contoh  :- 
Perkataan –perkataan seperti 
hikmat, berhikmat, ajaib, 
keajaiban, kesucian, kesyurgaan, 
(Miracle, magic, magical, 
miraculous, saintly, heavenly)  
 
9. Tidak dibenarkan menggunakan nama 
produk yang seakan -akan sama dengan 
produk yang telah berdaftar.  
Nama menyerupai nama produk yang telah 
berdaftar dari segi ejaan & sebutan  
 Contoh: - 
Tenormin vs Tenormine vs 
Tenormy  
Re-Liv vs Re -Lif 
10. Tidak dibenarkan menggunakan nama 
produk yang mengelirukan samada 
drug/ makanan/minuman  
Nama yang menyerupai produk 
makanan/minuman  
 Contoh: - 
Juice, Health drink, Beverage, 
Kooky  
11. Tidak dibenarkan menggunakan nama 
yang melambangkan nasihat 
Profesional – tanggapan nasihat  
 Contoh: - 
Dr Sunny, Dr Noortier Rooibose 
Tea, Professor  
12. Tidak dibenarkan menggunakan nama 
yang melambangkan pengurangan berat 
badan / melangsingkan badan  Contoh : - 
Slim, Langsing, Trim,  Trimnfit  
13. Lain –lain nama produk yang tidak 
dibenarkan  
 Contoh : - 
Minda, IQ , Smart  
 
 
English Version  
 
Appendix 12.8 List of Non Permissible Product Name for Natural Products  
 
No. Issue  Example  
1.  Prohibited use of disease names as 
stated in the Medicines (Advertisement 
and Sale) Act 1956 (Revised 1983)  Example :  
Diabetes, Asthma, Cancer  
2.  Prohibited use of a single active 
ingredient as a product name in 
products containing more than one 
active ingredient unless product name 
contains words such as ‘Plus, 
Compound, Complex, Herbanika  Example :  
Tongkat Ali Capsule ---- 
But product contains tongkat ali, 
ginseng,  ect. 
3.  Prohibited use of superlative - Names 
which indicates superiority inef ﬁcacy  Example :  
Power, Superior, Pure, Mustajab, 
Safe, Healthy, Penawar, VIP, 
Good   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 2034.  Prohibited use of spelling of words 
which may cause confusion  
Words which involve names of/part 
thereof:  
i) 20 disease names prohibited in the 
Medicines (Advertisement and Sale) Act 
1956 (Revised 1983)  
ii) Other diseases without scienti ﬁc proof  
iii) Prohibited indication  Example :  
a) Go Out = GOUT (label)  
b) UTix  
5.  Prohibited use of names whi ch may 
cause ambiguity  
Ambiguous product name  Example:  
B For Energy ?  
6.  Prohibited use of names which may be 
offensive or indecent  Example:  
SENXBIG=SEnXBIG(label)  
Sexy, Enjoy, Paradise,  
Heavenly, Blue boy, Casanova, 
Desire  
7.  Prohibited use of product names  which 
are incoherent with the approved 
indication  
Name containing a product claim whereas 
product is indicated for more than the 
approved indication  Example:  
Cough Syrup X= Approved 
indication for cough, dizziness, ﬂu 
and itch  
8.  Prohibited use of product names which 
has elements of ludicrous belief  
Statements referring to ancient believe/ 
negative spirits/supernatural power  Example:  
Words such as miracle, magic, 
magical, miraculous, saintly, 
heavenly  
9.  Prohibited use of product names similar 
to the existin g approved product names  
Product names similar to the spelling and 
pronunciation of words of the existing 
product names  Example:  
Tenormin vs Tenormine vs 
Tenormy  
Re-Liv vs Re -Lif 
10.  Prohibited use of product names which 
may cause ambiguity in the nature of 
product (drug/food/beverage)  
Product names similar to a food/beverage 
product  Example:  
Juice, Health drink, Beverage, 
Kooky  
11.  Prohibited use of product names which 
represents professional advice or 
opinion  Example:  
Dr Sunny, Dr Noortier Rooibose 
Tea, Professo  
12.  Prohibited use of product names which 
represent weight loss/slimming 
properties  Example:  
Slim, Langsing, Trim, Trimnfit  
13.  Other prohibited product names  Example:  
Minda, IQ, Smart  
 
 
*This list is not meant to be exhaustive.  
*It may be reviewed as and when it is deemed necessary  
*DCA reserves the right to disallow any other wor ds or phrases for product names 
which in its opinion is misleading, improper or not factua 
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 20412.9   List of Non Permissible Indications for Natural Product  
 
 
1. Penyakit atau kecacatan ginjal / Disease or defects of the kidney  
 
2. Penyakit atau kecacatan jantung / Disease or defects of the heart  
 
3. Kencing manis / Diabetes  
 
4. Epilepsi atau sawan / Epilepsy or fits  
 
5. Kelumpuhan / Paralysis  
 
6. Tibi / Tuberculosis  
 
7. Asma / Asthma  
 
8. Kusta / Leprosy  
 
9. Kanser / Cancer  
 
10. Kepekakan / Deafiness  
 
11. Ketagihan dadah / Drug addiction  
 
12. Hernia atau pecah / Hernia or rupture  
 
13. Penyakit mata / Disease of the eye  
 
14. Hipertensi (Darah Tinggi) / Hypertension  
 
15. Sakit otak / Mental disorder  
 
16. Kemandulan / Infertility  
 
17. Kaku / Frigidity  
 
18. Lemah fungsi seks atau impoten  / Impairment of sexual function or impotency  
 
19. Penyakit venerus / Venereal disease  
 
Lemah urat saraf atau aduan atau kele mahan lain timbul daripada atau 
perhubungan dengan perhubungan seks / Nervous debility or pother 
complaint of   infirmity arising from or relating to sexual intercourse.  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 205 
 
 
 
 
 
 
 
 
 
 
 
 
SECTION 2: GUIDE ON HOW TO FILL THE ON -LINE APPLICATION 
FORM  FOR A NEW PRODUCT REGISTRATION  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GUIDE ON HOW TO FILL THE ON -LINE APPLICATION FORM   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 206FOR A NEW PRODUCT REGISTRATION  
 
1. Separate modules are available for a) pharmaceuticals, & b) traditional products.  
Please ensure that you click on the appropriate section of the display panel and  
fill the correct application form.  
{NOTE: THE PROCESSING FEE, ONCE PAYMENT HAS BEEN CONFIRMED,  
CANNOT BE REFUNDED EVEN IF THE WRONG APPLICATION FORM HAS  
BEEN USED}  
2. The following guidance notes are arranged according to the layout of the  
application form.  
3. Attac hments can only be made where there is a “paper clip” sign.  
4. Applicants who are attempting to fill up this form for the first time are advised to  
familiarize  themselves with the drug registration system in Malaysia by reading  
Section 1 of this guidance document.  
5. The technical requirements for pharmaceuticals have already been addressed  
elsewhere, (such as in the ICH & ASEAN guidelines), and applicants are advised  
to refer to these guidelines.  
 
Any application for a new product registration follows a 2 -step process:  
 
STEP 1: PRODUCT VALIDATION FORM  
 All fields are compulsory.  
 Option is given to accept the validation result and submit, or override and  
manually select.  
 Once validation is verified and submitted, the appropriate application form (Step  
2) will b e displayed.  
 Information entered in Step I will be captured in the data base and need not be  
re-entered at Step 2.  
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 207[1] PRODUCT NAME  
To enter product name, dosage form and strength   
(e.g. X Brand Paracetamol Tablet 500mg)  
 
[Product name is defined as “A name given to a product which may be  either a 
proprietary name (an invented name); or a generic name (common  name) or 
scientific name, together with a trade mark or the name of the  manufacturer”.]  
 
The invented name shall not be liable to confusion with  the common name.  
The generic name means the international non -proprietary name recommended  by 
WHO (rINN), or if one does not exist, the usual approved name.  
This name will be shown on the product labelling i.e. inner label, outer carton, package  
insert an d patient information leaflet.  
Dosage form and strength of product would need to be entered as part of  product name 
to allow for multiple dosage forms (e.g. tablet, capsule) and  strengths (e.g. 200mg and 
400mg) for any particular named (proprietary or  gene ric) product.  
 
[2] DOSAGE FORM  
Please select from given list. A tablet may be plain, chewable, coated (enteric, film, or  
sugar), dispersible, effervescent, extended release, subligual, etc. The form that  
correctly describes it in terms of its product quali ty control specifications and  
performance should be selected.  
A separate application  for registration is required for each dosage form.  
 
[3] ACTIVE SUBSTANCE  
Substance Name : Please pick substance name from the search database. If substance  
is not listed, it may be entered manually and will be added onto the list. Please ensure  
that the spelling is accurate.  
The actual raw material that is employed in the manufacturing process should be  
named, for example,  
 where the raw material used is the salt (e.g. ampic illin trihydrate) which will yield  
an equivalent effective component from its base content (i.e. ampicillin), the 
substance  name is the salt and the equivalent base component should be 
indicated in the remarks  on substance (if any) field 6 
 similarly where a chemical is a component in the ingredient; e.g. iron in ferrous  
sulfate; or EPA and DHA in fish oil, the component details should be stated in the   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 208remarks field if a label claim of the component is made for the product, and the 
actual  raw material used d eclared as the active substance  
 
Strength of substance : to enter the content of active ingredients (numerical) and then  
select the weights and measures from the given list.  
 
Note 1 : International Non -proprietary Names (INN), approved names,  pharmacopoeia 
names of ingredients should be used whenever possible.  
Note 2 : Content of ingredients should be expressed as appropriate in the  following 
manner: - 
a. quantity per dose unit (e.g. for unit dose formulations - tablet,  capsule, lozenge, 
etc.) 
- percentage composit ion ; - %w/w, %w/v, %v/v, etc. (e.g. for  products 
without defined dose unit – ointments, creams,  solutions, etc.)  
b. weight per ml. (e.g. for solutions, injections, etc.)  
c. quantity (percentage or amount) per measured dose (e.g. oral  liquids, metered 
aerosols, drops, etc.)  
Note 3 : Metric weights and measures shall be used.  
Note 4 : In cases where product contains active ingredient(s) that cannot  be definitely 
identified (e.g. certain biological products) state the  name of the material to which 
activity is ascribe d and, where  appropriate, the potency or activity of the product.  
 
[6 Remarks on substance (if any) : This field should be used where the raw material  in 
product formulation yields an equivalent active component . ] 
After each ingredient entry is correctly made, click the add button. The remove button  
will allow for corrections to an entry under this heading. To remove item, select item  
from the listing and click remove.  
 
[4] EXCIPIENT  
Details as for [3] above.  
Also to indicate function of substance e.g. swe etener, preservative, etc (select from  
display list).  
 
 
[5] ANY PORCINE MATERIALS  
Click the appropriate button (Yes / No).   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 209 
[6] MANUFACTURER  
[Manufacturer is defined as “A company that carries out at least one step of  
production as well as the final release of the finished product ”.] 
Click to search from data base. For a new manufacturer details will need to be  
submitted.  
Status as to whether the declared manufacturer is a contract manufacturer or otherwise  
has to be entered.  
 
[7] PRODUCT CLASSIFICATI ON 
FOR PHARMACEUTICALS  
NOTE : Product classification with * in the list that follows apply only to products which  
do not contain ingredients which are controlled poisons . Only the OTC products  
which fall under the * category undergo the abridged registration application procedure.  
Other OTC products and products which contain controlled poisons will need to provide  
complete  Documentation for both Parts I & II.  
Pick one of the following from the list that is displayed:  
(NB: * categories  below are o nly applicable to OTC products which  are processed 
via the abridged application procedure. DO  NOT pick these if your product 
contains controlled poisons.)  
 Lozenges/pastilles  
 Topical analgesic/counter -irritants  
 Topical nasal decongestants  
 Emollient/demulcent/protectants  
 Dietary supplements  
 Keratolytics  
OTC other than listed above  
(Note: For products which undergo full evaluation)  
Controlled poison  
New Chemical Entity  
(Note: Biological/Biotech products go under this category)  
 
FOR TRADITIONA L PRODUCTS  
[NOTE: DO NOT USE THE PHARMACEUTICALS MOD ULE]  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 210Traditional products have a separate module altogether. Information that is  
required under Part I, Step 2 follow requirements for traditional products only.   
Pick from the list displayed:  
 Traditional  
 Homeopathy  
 Dietary supplements/Food supplements  
 
STEP 2 : NEW REGISTRATION APPLICATION FORM  
The application form displayed at Step 2 will depend on the type of product being  
submitted:  
Abridged Evaluation (certain OTCs , and for traditional products) – Part I only  
Generic Pharmaceutical Products – Parts I & II  
Existing chemical or biological entity(s) in new dosage form – Parts I & II together with  
pharmacokinetic data.  
NCE and Biotech Products - Parts I to IV.  
Part I – Administrative Data and Product I nformation  
Part II – Quality 7 
Part III – Non-clinical  
Part IV – Clinical  
Please refer to the Glossary developed for the ACTD and ACTR. The definitions used  in 
this glossary have been developed for the ASEAN Common Technical Dossier  (ACTD) 
and Common Technical Requirements (ACTR). They are not necessarily  meaningful 
outside the scope of the specific parts of ACTD and ACTR to which they  refer.  
[7 Please refer also to the following guidelines which have been prepared to facilitate  
submission of relevant documents and samples for PART II (attached as Annex A ) 
 Guidelines for submission of protocol of analysis  
 Guideline for submission of samples to the Drug Analysis Division for Laboratory  
Testing  
 Guidelines for submission of analytical method validation doc uments ] 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 211PART I – ADMINISTRATIVE DATA AND PRODUCT INFORMATION  
Details of product name, dosage form, formulation (actives and excipients) as entered  
under Step 1 will appear automatically.  
 
SECTION A: PRODUCT PARTICULARS  
Other fields (as follow) will need  to be completed.  
 
 Product  Description :  
State here, briefly, visual and physical characteristics of the product, including where  
applicable : - 
Shape, size, superficial markings for identification purposes, colour, odour, taste,  
consistency, type of tablet  coating, type of capsule, etc.  When describing liquids, 
state clearly whether it is in the form of a solution (clear),  suspension, emulsion, 
etc. 
 Pharmacodynamics & Pharmacokinetics (for full evaluation only)  
Give a concise yet comprehensive summary of th e pharmacological profile  
- main and supplementary pharmacological effects ( mechanism of  action, 
actions other than the therapeutic effects);  
- relevant pharmacokinetics (absorption, plasma -protein binding,  
distribution, biotransformation, metabolism, excreti on, etc) ;  
- bioavailability and bioequivalence studies in man.  
 Indication/Usage  
State briefly recommended clinical use(s) of p roduct, indicating clearly also whether  
curative, palliative, adjunctive, diagnostic, etc.  
Note 1 : Indications should be specific; phrases such as ‘associated conditions’ or ‘allied  
diseases’ would not normally be considered appropriate.  
Note 2 : Indications other than those specified and accepted at the time of registration  
must not be included in any product literature, data sheets, package inserts, labels, etc,  
without the prior permission of the DCA.  
Note 3 : Should it be desired to include new indications, an application shall be filed with  
the DCA together with supporting clinical documentation on evidence of efficacy and  
safety for the additional uses (indications).  
Note 4 : In the case of products which are to be used as dietary supplements, no claims  
may be made for the prevention and treatment of disease states.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 212 Dose/Use Instruction  
 Recommended Dose & Route of administration (f or full evaluation 
only)  
State the dose (normal dose, dose range) and dosage schedule (frequency, duration)  
[and route of administration appropriate for each therapeutic indication]. Dosage for  
adults, and where appropriate children, should be stated.  
Dosa ge adjustments for special conditions e.g. renal, hepatic, cardiac, nutritional  
insufficiencies, where relevant, should be stated.  
Note 1 : Where appropriate, diluents and instructions for dilution, reconstitution and use  
or administration of the product sh ould be clearly stated.  
Note 2 : Distinction should be made between therapeutic and prophylactic doses, and  
between dosages for different clinical uses where applicable.  
Note 3 : Ensure that dosage recommendation is relevant and appropriate for the  
product.  
 Contraindication  
State conditions for which or under which the product should not be used.  
Note 1 : Indicate clearly which conditions are absolutely contraindicated, which are  
contraindicated but under special circumstances may be used and what precautions to 
be taken in such cases.  
Note 2 : Where there is likelihood especially for intravenous solutions, that additives are  
added, foreseeable contraindicated additives should be mentioned.  
Note 3 : Include also, where possible, concurrent drug therapy which are  
contraindicated.  
 Warnings and Precautions  
State briefly precautions and warnings necessary to ensure safe and efficacious use of  
the drug, e.g. caution against giving to children and elderly; against driving motor  
vehicles or manning heavy machinery after intake of product; use in pregnancy and  
lactation; in infants; etc.  
 Drug Interactions  
State only interactions which are observed and/or for which there is potential clinical  
significance. Interactions may occur with  
- medicinal products used for the same ind ication;  
- medicinal products used for other indications;  
- meals, or specific types of food.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 213 Side Effects /Adverse Reactions  
State in order of severity and frequency, the side effects, adverse reactions, toxic  
effects, etc. (i.e. reactions, toxic effects, other than those desired therapeutically)  
including reactions such as allergy, hypersensitivity, drug dependence, addiction,  
carcinogenicity, tolerance, liver/kidney toxicity etc.  
Indicate also symptoms and sites of effects/reactions.  
Note 1  : Reactions, w hether minor or serious, should be stated.  
Note 2  : Severity, reversible, frequency of occurrence should be indicated where ever  
possible.  
Note 3 : Clinical tests for detection of ‘sensitive’ patients, measure for management of  
adverse reactions developed shall be described wherever possible.  
 Pregnancy and Lactation (for full evaluation only)  
The following should be mentioned;  
a. conclusions from the animal reproduction/fertility study and the human  
experience;  
b. the risk in humans at different times of pregnanc y, as assessed from a);  
c. information on the possibility of using the medical product in fertile and 
pregnant  women.  
Use in lactation:  
When the active substance(s) or its metabolites are excreted in the milk, a  
recommendation as to whether to stop or continu e breast feeding, and the likelihood  
and degree of adverse reaction in the infant should be given.  
 Signs and Symptoms of Overdose and Treatment  
State briefly symptoms of overdose/poisoning, and where possible, recommended  
treatment and antidotes for overdo se/poisoning.  
 Storage Conditions  
State the recommended storage conditions (temperature, humidity, light etc.).  
Storage conditions of reconstituted products should also be included where  
applicable.  
The storage conditions for all the listed pack  types should be supported by stability data.  
 Shelf Life  
The shelf life for all the listed pack types should be supported by stability data.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 214Information should also include shelf life before first opening, after reconstitution and/or  
after opening where ap plicable. Stability data to support such shelf life should be  
available.  
Evidence is required to demonstrate that the product is stable (meets the finished  
product check (expiry) specifications throughout its proposed shelf -life, that toxic  
decomposition p roducts are not produced in significant amounts during this period, and  
that potency, sterility, efficacy of preservative, etc are maintained.  
 Therapeutic Code (If any)  
Applicants should indicate the WHO assigned ATC code for each distinct therapeutic  
indication proposed for a product, if such a code is available. Click to search database.  
 
SECTION B : PRODUCT FORMULA  
 Batch Manufacturing Formula  
Give the batch size and actual batch manufacturing master formula . Data from  
validation step will be captured in terms of substance name, type (active or excipient  
ingredient), function and quantity per unit dose. Other information will need to be  
entered.  
An attachment of the Batch Manufacturing Formula documentation can also be made.  
 Manufacturing process (for abri dged evaluation procedure only)  
Enter a brief description of the manufacturing process. Essential points of each stage of  
manufacture should be covered. Also to furnish a description of the assembling of the  
product into final containers. If the product is  repacked/assembled by another  
manufacturer, details of repacking/assembly and quality control must be supplied.  
An attachment of the manufacturing process, in the form of a flow chart can be made.  
 Attachment of In Process Quality Control (for abridged eva luation 
procedure  only)  
To give a summary of the tests performed  stages at which they are done, and the  
frequency of sampling and number of samples taken each time. Specifications for  
quality assurance of the product should be supplied.  
 Attachment of Finis hed Product Quality Specification (for abridged 
evaluation  procedure only)  
Give details of quality control specifications including a list of tests (for both release and  
expiry/check specifications, if they are different) and state the limits of acceptance . 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 215 Attachment of Stability Data (for abridged evaluation procedure only)  
Reports of stability studies should provide details of the batches placed under study (a  
minimum of 2 batches are required), containers/packaging type, conditions of storage  
during st udy (temperature, humidity, etc) duration of study and frequency (interval) of  
the tests/observations, and the tests performed (including degradation products being  
monitored) and acceptance limits.  
 
SECTION C : PARTICULARS OF PACKING  
To add packing particulars to the listing of packing,  
- select pack size (C1) and fill details by weight, or volume or quantity;  
- select container type (C2);  
- key in Barcode/serial No (C3) (not compulsory);  
- key in recommended distributor’s price (C4) (not compulsory);  
- key in  recommended retail price (C5) (not compulsory);  
and then click “Add” button  
To add next particulars repeat the same process until all the packings are listed  
accordingly. To remove any item from the listing, select item from the listing and click  
the “Rem ove” button . 
 
[Subject also to requirements stated in paragraph 13.9 Guide for Implementation 
of Patient Dispensing Pack For Pharmaceutical Products in Malaysia, under 
Section 1 GENERAL OVERVIEW OF THE DRUG REGISTRATION SYSTEM IN 
MALAYSIA (INCLUDING ADMINI STRATIVE PROCEDURES)  
 
 
 
 
 
 
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 216SECTION D: LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER CARTON 
AND PROPOSED PACKAGE INSERT  
 
Outer(Carton), Inner & Blister/Strips Labels  
The following information should be present on the labeling of the product  
 
 Parameters  Unit 
Carton  Inner 
Labels  Blister/Strips  
1. Product Name     
2. Dosage Form   * NA 
3. Name of Active Substance(s)    ** 
4. Strength of Active Substance(s)    ** 
5. Batch Number     
6. Manufacturing Date   * NA 
7. Expiration Date     
8. Route of Administration    NA 
9. Storage Condition   * NA 
10. Country’s Registration Number   * NA 
11. Name & Address of Marketing 
Authorization (Product Licence) 
Holder   * Name/Logo of 
Manufacturer/  
Product 
Owner  
12. Name & Address of Manufacturer   * NA 
13. Warnings (if applicable)   * NA 
14. Pack Sizes (unit/volume.)    NA 
15. Name & content of preservative(s) 
where present    NA 
16. Name & content of alcohol, where 
present    NA  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 21717. To declare source of ingredients 
derived from animal origin, including 
gelatin (active, excipient, and /or 
capsule shell)    NA 
18. Recommended daily allowance (RDA) 
for vitamins / multivitamins / mineral 
preparations used as dietary 
supplements    NA 
19. The words “Keep medicine out of 
reach  of children” or words bearing 
similar meaning in both Bahasa 
Malaysia & English    NA 
20. Other country specific labelling 
requirements (if applicable)   * NA 
21. The words “Controlled Medicine/ Ubat 
Terkawal” (for scheduled poison only)   * NA 
22. Security Label   * NA 
 
No. 15 ,19,21 & 22  of labeling requirements: Country specific for Malaysia   
            NA - Not applicable                    
* Exempted for small  labels such as used in ampoules and vials    
** For multi -vitamins and minerals preparations it is suggested to label as 
multi -vitamins and minerals  
 
If the product is without an outer carton, the inner label should bear all the 
information that is required  
 
Official website of the company or website fo r any purpose of product promotion 
from the MAH/product owner/manufacturer is not allowed to be printed on the 
product label (applicable to all categories of products included imported 
products). However, email address of the company is permissible.  
 
Product that contains Nevirapine :  
Addition of phrase “Restriction of nevirapine use in patient with CD4+cell count 
greater than 250cells/mm3” on the product label.  
Product holder is fully responsible to inform prescriber pertaining to the 
restriction in u se of Nevirapine.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 218Package inserts  are required for products classified as Controlled poisons. They may 
also be submitted for OTC products. The draft copy of the package insert should be 
submitted for evaluation. The following information is required to be included in the 
package insert:  
(i) Brand or Product Name  
(ii) Name and Strength of Active Substance(s)  
(iii) Product Description  
(iv) Pharmacodynamics / Pharmacokinetics  
(v) Indication  
(vi) Recommended Dosage  
(vii) Mode of Administration  
(viii) Contraindications  
(ix) Warnings and Precautions  
(x) Interact ions with Other Medicaments  
(xi) Statement on usage during pregnancy and lactation  
(xii) Adverse Effects / Undesirable Effects  
(xiii) Overdose and Treatment  
(xiv) Incompatibilities (for injections only)  
(xv) Storage Conditions (may be omitted if the information is stated 
on the label or outer carton labels)  
(xvi) Dosage Forms and packaging available  
(xvii)  Name and Address of manufacturer/marketing authorization 
holder  
(xviii)  Date of Revision of Package Insert  
 
Patient Information Leaflet (PIL)  can be submitted in place of a package insert for an 
OTC prod uct. The draft copy of the PIL should be submitted for evaluation. A PIL may 
also be submitted as additional information for controlled poison products. The following 
information is required to be included in the PIL:  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 219If the product is sold without a PIL, the information that is required to be included in the 
PIL should be included in the outer carton  
SECTIONS D, E & F8: SUPPLEMENTARY INFORMATION  
 The Summary of Product Characteristics (SPC), if any, Package Insert (PI) and 
/or PIL approved by the country of origin should be submitted with the 
application.  
 Applicants who hold valid patents should provide documentary evidenc e of the  
nature and extent of their patents.  
[8 Section F - for abridged evaluation procedur e only, which does not have 
Part II] 
 
PART II, III & IV – QUALITY , NON -CLINICAL (SAFETY) & CLINICAL 
(EFFICACY) DOCUMENTATION  
Please refer to ASEAN Technical Requi rements Guidance Documents available at  
http://www.bpfk.gov .my/Regulatory Info/Other Guidelines/ ASEAN Guidelines  I. Name of Product  
II. Description of Produ ct 
III. What is the medicine?  
IV. Strength of the medicine  
V. What is this medicine used for?  
VI. How much and how often should you use this medicine?  
VII. When should you not take this medicine?  
VIII. Undesirable effects / side effects  
IX. What other medicine or food should be avoided whilst taking this medicine?  
X. What should you do if you miss a dose?  
XI. How should you keep this medicine?  
XII. Signs & symptoms of overdose  
XIII. What to do when you have taken more than the recommended  dosage?  
XIV. Name/logo of manufacturer/importer/marketing authorization holder  
XV. Care that should be taken when taking this medicine?  
XVI. When should you consult your doctor?  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 220 
 
ANNEX A  
Guidelines for the Submission of Protocol of Analysis  
I. General Requirements  
1. The Protocol of analysis must be in a standard format that contains information  
as stated below: - 
a. Product name  
b. Name and address of manufacturer  
c. Name, signature and designation of authorized person  
d. Effective date  
e. Review date  
2. Protocol of analysis must consist of all test methods and specifications that are  
carried out by the manufacturer. Standard pharmacopoeias, for example,  
BP/USP can be used as references. The tests and specifications in the  
pharmacopeias are the minimum requirements.  
3. Photocopies of methods/ methods directly copied from pharmacopoeias are not  
acceptable. Manufacturers can use methods from those standard references but  
must have their own written and detailed procedure.  
4. Manufacturers must confirm that all test methods in their protocol of analysis  
perform as expected. Copies of chromatograms (H PLC/GC/TLC), UV spectrum  
etc must be submitted together with the protocol of analysis.  
5. Protocol of analysis must be properly ordered with proper numbering for all tests  
and specifications.  
6. All references stated in the protocol of analysis must be submitted  and clearly  
labeled.  
7. Protocol of analysis submitted must be in either Bahasa Malaysia or English.  
Protocol of analysis in other languages will be rejected.  
8. An authorized copy of latest certificate of analysis for the product concern must  
be submitted with  the protocol of analysis.  
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 221II. Specific Requirements  
1. Identification test  
a. List of equipment and apparatus required.  
b. List of chemical / reagents  
c. Preparation o f sample and standard solutions  
d. Details of method and procedures  
e. Specification and acceptance criteria  
2. Physical test (friability, uniformity  of weight, pH, viscosity, etc)  
a. List of equipment require d together with test parameters  
b. Sample preparation (if any)  
c. Specification and acceptance criteria  
3. Disintegration test  
a. Equipment required  
b. Test parameters  
c. Test medium  
d. Specification  
4. Dissolution test  
a. Equipment  and apparatus required  
b. List of chemical / reagents required  
c. Test parameters i.e. type and volume of dissolution medium, rotation rate,  
temperature of solution and time  
d. Preparation of dissolution medium, preparation of sample and standard  
solution (if any), etc  
e. Type and method of analysis (HPLC, UV, etc) and test procedures. For  
example, if HPLC method is used, test method has to include the  
preparation of mobile phase, brand and type of column used, run t ime, 
detector used (UV, RI, etc), injection volume, system suitability test and  
other parameters.  
f. Typical chromatograms / UV spectrum for sample & standard solution,  
system suitability etc  
g. Complete formula for calculation. For example, ‘slow release’ products  
calculation must include quantity of active substance in the medium 
volume  which has been taken out for analysis.  
h. Test specification   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 2225. Impurities / degradation / purity test  
a. List of equipment and apparatus required,  
b. List of chemical and reagents required.  
c. Preparation o f sample and standard solutions  
d. Detailed method and procedures  
e. Complete formula for calculation.  
f. Typical chromatogram of system suitability test, sample & standard  
solutions if applicable  
g. Spec ification / acceptance criteria  
6. Assay and  uniformity of content  
a. List of equi pment and apparatus required  
b. List of chemical and reagents required.  
c. Preparation of sample and standard solution  
d. Detailed method and procedures  
e. Complete formula for calculation.  
f. Typical chromatogram/spectrum of system sui tability test, sample &  
standard solutions if applicable  
g. Spec ification / acceptance criteria  
7. Pyrogen / abnormal toxicity test  
a. List of equipment, apparatus, glassware and reagents required.  
b. Preparation of sam ple solution and injection dose  
c. Test method & procedure.  
d. Test interpretation  
e. Test specification  
8. Bacterial Endotoxins Test (LAL)  
a. List of apparatus, glassware and reagents required.  
b. Preparation of standard solution, L AL reagent/substrate and sample  
c. Determination of MVD (Maximum Vali d Dilution) and endot oxin limit  
d. Detailed test procedure  
e. Calculation and interpretation of test result  
f. Test specifications  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 2239. Microbial Limit Test  
9.1 Determination of microbial contamination test  
i. List of apparatus and culture required.  
ii. Preparation of test m edium and growth promotion test  
iii. Sample preparation including method for neutralizing of preservatives  for 
samples that contain preservatives  
iv. Complete test procedure by ‘surface spread’ for bacteria and ‘pour  plate’ 
for fungi.  
v. Colony counting  
vi. Specification and acceptance cr iteria  
9.2 Test for specified microorganisms and total viable aerobic count  
i. List of apparatus and culture required.  
ii. Preparation of test m edium and growth promotion test  
iii. Sample preparation including method for neutralizing of preservatives  for 
samples that contain preservatives  
iv. Complete test procedure for each of specific microorganism involved.  
v. Observation on colonies presence  
vi. Specifi cations and acceptance criteria  
 
10. Sterility test  
a. List of apparatus required.  
b. List of biological and chemical substance required: - 
i. Culture medium  
ii. List of rinsing solution, buffer solution and diluent  
iii. Neutralizing agent (if any)  
iv. List of specific type cultures required  
c. Method used (e.g. membrane filtration method, direct inoculation,  etc) 
d. Method of preparation of the followin g solutions/materials: - 
i. Culture medium (e.g. Fluid Thioglycollate Medium and Soyabean  
Casein Digest Medium)  
ii. Rinsing solution, buffer s olution and diluents  
iii. Neutralizing agent (if any)  
iv. Microorganism culture   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 224e. Growth promotion test for medium used in sterility testing (specific 
aerobes,  anaerobes and fungi).  
f. Preparation of sample solution (including neutralizing procedure of  
antimicrobial agent for antibiotic samples and samples which contain  
preservatives).  
g. Complete test procedure for sterility test.  
h. Specificat ions and acceptance criteria.  
i. Validation procedure & validation data (if applicable).  
 
11. Microbiology assay  
a. List of apparatus required.  
b. List of biological and chemical substances required.  
c. Procedure for the preparation of following solutions/substances: - 
i. Culture mediums  
ii. Rinsing solutions.  
iii. Buffer solutions  
iv. Diluents  
v. Microorganism culture used in assay  
d. Test method (e.g. agar diffusion, turbidimetric, randomized block, dose, 
etc) 
e. Test procedure  
i. Preparations of solutions containing antimicrobial agents which 
may be present in the samp le to be tested (if applicable)  
ii. Preparation of standard solutions (including any steps to counteract  
the antimicrobial properties of any preservatives, etc present in the  
sample)  
iii. Preparation of test solutions (including any steps to  neutralize the  
antimicrobial properties of any preservatives, etc present in the  
sample)  
iv. Dilution schemes for test and standard solutions.  
v. Application of test & standard solutions (volume, latin squares, etc)  
vi. Incubation temperature & time  
vii. Procurement of t est data.  
f. Complete calculation for the test including ANOVA tablet and other data  
showing validity of test results.   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 225g. Specifications and acceptance criteria.  
 
Guidelin e for Submission of Samples to t he Drug Analysis Division  for 
Laboratory Testing  
I. Introduction  
This guideline is written for the purpose of informing applicants on the Drug  Analysis 
Division requirements when receiving samples for laboratory testing as  part of the 
registration process. Applicants are required to comply with these  requir ements as their 
samples can be rejected if they fail to meet any of these  requirements .  
 
II. Requirements  
a. Applicants must make appointment with the Laboratory Services Unit for the  
submission of registration samples for laboratory testing.  
b. Requirements fo r samples: - 
A. Pharmaceuticals  
a. Samples submitted must be in their original packaging & labeling.  
b. Quantity of samples submitted must be in accordance with the  quantity 
requested for in the protocol of analysis evaluation report.  
c. Samples submitted must be fr om the same manufacturing premise  as that 
stated in the application for registration.  
d. Samples submitted must have an expiry date of least one (1) year  from 
the date of submission.  
e. An official certificate of analysis from the manufacturer for the same  batch  
of sample must be submitted with the sample.  
B. Traditional Products  
a. Samples submitted must be in their original packaging & labeling.  
b. Quantity of samples submitted must be in accordance with the  quantity 
requested. A minimum of 4 separate containers with  total contents not 
less than 50gm.  
c. Samples submitted must be from the same manufacturing premise  as that 
stated in the application for registration.  
d. Samples submitted must have an expiry date of least one (1) year  from 
the date of submission  
c. Requirements for reference standards (Pharmaceuticals only)   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 226i. The type & quantity of reference standards submitted must be in  
accordance with the type & quantity requested for in the protocol of  
analysis evaluation report.  
ii. Reference standards submitted must have an expiry date of least  one (1) 
year from the date of submission. In special situations, an  expiry date of 
not less than six (6) months can be accepted.  
iii. All reference standards must be accompanied by an official  certificate of 
analysis for the same batch with  the stated purity (as  is, dried, anhydrous 
etc) and all other relevant information (water  content, loss on drying etc).  
iv. All reference standards must be properly labeled with name, batch  
number, purity and expiry date.  
v. All reference standards must be submi tted in small sealed air -tight amber 
glass containers.  
d. Other materials such as HPLC columns, reagents, etc requested for in the  
protocol of evaluation report must be submitted.  
e. For imported products, the original import permit endorsed by the  enforcement 
officer at the entry point must be submitted. For locally  manufactured products, a 
copy of the batch manufacturing record (BMR)  must be submitted.  
 
III. Appeal for retesting  
a. Applicants are allowed only one (1) appeal for any sample that fails  laboratory 
testing in the Drug Analysis Division subjected to approval by the  Deputy 
Director, Drug Analysis Division.  
b. Appeal for retesting must be submitted through the on -line registration  system to 
the Deputy Director, Drug Analysis Division within 30 days from  the date the 
results is sent to the applicant. No appeals will be entertained  after 30 days as 
the on -line registration system does not allow appeal for  retesting after the 
results of the laboratory testing is release to BPKP  (Product evaluation & Safety 
Division). Results of laboratory tests of failed  samples are only release to BPKP 
30 days after the applicants are informed  of the results to enable them to submit 
their appeal.  
c. Appeals for retesting must be substantiated with reasons for the failure as  well as 
corrective actions taken to overcome the failure. The decision to  approve or 
reject the appeal lies with the Deputy Director, Drug Analysis  Division.  
d. If the appeal for retesting is approved, the applicant will be requested to  submit 
the sample together with all reference standards & other materials  requested for 
in the original protocol of analysis evaluation report. This  sample will be treated 
as a normal registration sample and the applicant will  be required to pay for all 
tests conducted on this sampl e.  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 227e. If there is no appeal within 30 days or if the appeal is rejected, the result of  the 
original tests is final and the sample will be considered as failed  laboratory 
testing.  
f. The result of the re -tested sample is final and there is no provision for a  second 
appeal.  
 
Guideline for Submission o f Analytical Method Validation  Documents  
I. Introduction  
The requirements for the submission of the analytical method validation data and  
documents by the industry to the Drug Analysis Division, National Pharmaceut ical 
Control Bureau (NPCB) are presented in this guide.  
All the analytical validation done by the industry should be in accordance to  ASEAN and 
ICH Technical Requirements Guidance Documents specifically: - 
Q2A: Text on validation of analytical procedures, 1 994 
Q2B: Validation of analytical procedure: methodology, 1996  
 
II. Requirements  
The industry is required to submit the following documents for evaluation by  NPCB: - 
a. Analytical method protocol for the testing of the raw materials (only  the active 
pharmaceutical ingredients (API) and preservatives if  any). This should 
include the specifications and certificate of  analysis. All analytical test 
procedures where possible should be in  accordance with the official 
monograph of that ingredient in the  latest edition of the official pharmacopoeia 
such as British  Pharmacopoeia, United States Pharmacopoeia and WHO.  
b. Analytical method validation protocol for the finished product. The  protocol of 
analysis should be in accordance with NPCB’s  guidelines for the sub mission 
of protocol of analysis.  
c. Protocol for the analytical method validation procedure carried out  on the 
finished product. This procedure should include all details  about the validation 
process including preparation of all solutions  used – standards, samples, 
placebo etc, detection methods, test  conditions, equipment used, statistical 
analysis & evaluation,  calculations etc.  
Types of analytical procedures to be validated includes: - 
a. Identification tests  
b. Quantitative tests for impurities' content  
c. Limit t ests for control of impurities   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 228d. Quantitative tests of the active ingredient in the sample  
e. Pyrogen / Bacterial endotoxin test  
f. Sterility test  
A brief description of the type of tests considered in this document is provided  below: - 
Identification tests are int ended to ensure the identity of an active ingredient  in the 
sample. This is normally achieved by comparison of a property of the  sample e.g. 
spectrum, chromatographic behavior, chemical reactivity, etc) to  that of a reference 
standard.  
Testing for impuriti es can be either a quantitative test or a limit test for the  impurity in 
the sample. Either test is intended to accurately reflect the purity  characteristics of the 
sample. Different validation characteristics are required  for a quantitative test than for a 
limit test.  
Assay procedures are intended to measure the content of active  pharmaceutical 
ingredient present in a given sample. The analytical data  submitted must be able to 
support the claim that the analytical method  employed has been validated.  
Pyroge n Test and Limulus Amebocyte Lysate Test - Relevant validation data for 
pyrogen test and Limulus Amebocyte Lysate Test  include product independent data 
such as equipment validation, validation of  temperature system, lysate sensitivity and 
product dependent  validation data  such as inhibition / enhancement studies and 
validation for routine LAL tests  according to the type of LAL test method employed eg. 
Gel Clot method,  quantitative end point method or quantitative kinetic method.  
Sterility testing app lied to  products that are required to be sterile. A  satisfactory result 
indicates that no contaminating microorganism has been  found in the sample examined 
in the condition of the test. For sterility testing it  is imperative that the testing procedure 
adopted by the manufacturers include  all aspects of validation of the testing method 
including the precautions  against microbial contamination.  
 
d. Complete set of data obtained from the validation process. These  include all 
raw data such as weights used, chromatograms,  tabulated sets of value as 
well as graphs, statistical analysis &  evaluation, calculations & formulae etc. 
Summary of data will not be  accepted. Acceptance criteria for each 
characteristic/ parameter  should also be submitted. For products tested using 
analytical  methods described in official pharmacopeias, users are not  
required to validate accuracy and reliability of these methods, but  must submit 
data verifying their suitability under actual conditions of  use. 
e. Certificate of analysis of three (3) recent batches of the finished  product  
f. Certificate of analysis for one b atch of API used in the product  
g. Summary on the validation process together with conclusion  reached.  
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 229Garis Panduan Mengemukakan Dokumen Validasi Analitikal (Pengujian 
Mikrobiologikal)  
I. Ujian Kontaminasi Mikrobial  
1.1 Senarai peralatan kritikal  
1.2 Senarai media dan reagen  
1.3 Prosedur penyediaan media dan reagen  
1.3.1 Media am  
1.3.2 Media selektif  
1.3.3 Larutan penampan, diluen dll.  
1.4 Senarai mikroorganisma yang diguna untuk setiap pro sedur validasi yang 
dijalankan  
1.5  Prosedur validasi media  (raw data perlu dikemukakan untuk satu 
kelompok keluaran siap)  
1.5.1 Media am  
- kesterilan media  
- keberkesanan media dan kesahihan pengiraan koloni  
1.5.2 Media selektif  
- kesterilan  
- ciri-ciri nutritif (growth promotion properties) dan selektif  
1.6  Prosedur penyediaan sampel  
1.6.1 Sampel larut air  
1.6.2 Sampel bukan lemak yang tidak larut air  
1.6.3 Sampel lemak  
1.6.4 Transdermal patches  
1.7  Prosedur peneutralan (jika berkenaan) bahan pengawet atau bahan yang  
merencat pertumbuhan mikroorganisma di dalam produk dan validasinya  
(raw data perlu dikemukakan untuk satu kelompok keluaran siap)  
1.8  Prosedur pengujian terperinci seperti yang dijalankan di makmal 
pengilang (raw data perlu dikemukakan un tuk satu kelompok keluaran  
siap)  
1.8.1 Pengujian Total Viable Aerobic Count  
1.8.2 Pengujian Mikroorganisma Spesifik  
1.8.3  Pengesanan, pengenalpastian dan pengesahan mikroorganisma 
spesifik   
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 2301.8.4 Penilaian kuantitatif Enterobakteria dan bakteria gram negatif lain  
1.9 Sijil analisa keluaran siap yang lengkap dengan spesifikasi dan keputusan  
ujian (3 kelompok untuk keluaran import dan 1 kelompok untuk keluaran 
tempatan)  
 
II. Esei Antibiotik Cara Mikrobiologikal  
2.1. Senarai peralatan kritikal  
2.2. Senarai media dan reagen  
2.3.  Senarai mikroorganisma yang diguna untuk prosedur validasi media  
2.4. Prosedur penyediaan media dan reage n (pelarut, penampan, pembilas, 
agen  peneutralan dll.)  
2.5.  Prosedur validasi media ( raw data perlu dikemukakan untuk satu 
kelompok keluaran siap)  
2.5.1. Kesterilan media  
2.5.2. Cir i-ciri nutritif media ( growth promotion properties ) 
2.6.  Prosedur penyediaan ampaian kultur mikroorganisma dan penentuan 
bilangan koloni per ml  
2.7.  Prosedur penentuan “dose -response curve” d an “dose ratio” ( raw data 
perlu  dikemukakan untuk produk berkenaan)  
2.8.  Prosedur penyediaan larutan piawai rujukan dan larutan sampel  
2.9.  Design esei yang diguna (randomised) untuk “small plate” atau “large 
plate”  
2.10.  Prosedur pengujian terperinci s eperti yang dijalankan di makmal 
pengilang  
2.11.  Keputusan ujian ( raw data perlu dikemukakan untuk satu kelompok 
keluaran siap)  
2.12.  Prosedur pengiraan potensi termasuk “statistical calculation”  
2.13.  Sijil analisa keluaran siap yang lengkap dengan spesifikasi dan keputusan 
ujian (3 kelompok untuk keluaran import dan 1 kelompok untuk keluaran  
tempatan)  
 
 
  
__________________________________________________________________________________           
 DRUG REGISTRATION GUIDANCE DOCUMENT (MALAYSIA)               
 231III. Ujian Steriliti  
3.1. Senarai peralatan kritikal  
3.2. Senarai media dan reagen  
3.3. Prosedur penyediaan media dan reagen  
3.4. Prosedur validasi  media ( raw data perlu dikemukakan untuk satu  
kelompok keluaran siap)  
3.4.1.  Kesterilan media  
3.4.2.  Ciri-ciri nutritif media ( growth promotion properties ), termasuk  
- senarai mikroorganisma rujukan yang diguna  
- prosedur penyed iaan ampaian kultur mikroorganisma 
rujukan danpenentuan bilangan koloni per ml  
3.5. Prosedur validasi tatacara pengujian steriliti ( raw data perlu dikemukakan 
untuk satu kelompok keluaran siap), termasuk  
3.5.1.  Senarai mikroorganisma rujukan yang diguna  
3.5.2.  Prosedur penyed iaan ampaian kultur mikroorganisma rujukan dan 
penentuan bilangan koloni per ml  
3.6. Prosedur pengujian terperinci seperti yang dijalankan di makmal 
pengilang  
3.7. Keputusan ujian dan interpretasi (raw data perlu dikemukakan untuk satu 
kelompok keluaran siap)  
3.8. Sijil analisa keluaran siap yang lengkap dengan spesifikasi dan keputusan  
ujian (3 kelompok untuk keluaran import dan 1 kelompok untuk keluaran  
tempatan)  
Nota:  
Prosedur yang disalin terus (samada difotostat atau diimbas) dari farmakopia tidak  
akan diterima.