G/TBT/N/MYS/91  
2 July 2019  
(19-4409) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  MALAYSIA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
National Pharmaceutical Regulatory Agency (NPRA)  
Ministry of Health  
Lot 36, Jalan Universiti  
46200 Petaling Jaya  
Selangor  
Phone: (+603)78835400  
Fax: (+603)79581312  
Website: www.npra.gov.my  
Name and address (including telephone  and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other  [  ]:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or 
more constituents which have been mixed together for therapeutic or prophylactic uses, 
not put up in measured doses or in forms or packings for retail sale. Other, contain ing 
antibiotics: Veterinary medicaments HS: 3003.20.0010 Medicaments (excluding goods of 
heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic 
or prophylactic uses, put up in measured doses (including those in the form of t ransdermal 
administration systems) or in forms or packings for retail sale. Other, containing 
antibiotics: Other: Of a kind taken orally or in ointment form: Veterinary medicaments 
HS: 3004.20.9110  
5. Title, number of pages and language(s) of the notified document:  Control of Drugs 
and Cosmetics Regulations 1984: Senior Director of Pharmaceutical Services Directive 
(Series No.10, 2019): Directive to Limit the Usage of Colistin in Veterinary Medicines (4 
page(s), in Malay)  
6. Description of content : The Directive is addressed to all product registration holder to 
limit the usage of colistin in veterinary medicines in which the usage of colistin is not 
allowed in veterinary medicines indicated for food -producing animals in the form of 
preparation to be added into the feed and water (for example premix, water soluble 
powder and solution).  
Registered product: Cancellation of registered product starting from 1st January 2020  
New application and products under evaluation status: Rejection of product regis tration 
application starting from the date of issuance of the Directive  G/TBT/N/MYS/91  
 
- 2 - 
 
  Renewal of product registration application: Allowed until 1st January 2020  
The Directive is not applicable for veterinary medicines containing colistin indicated for 
non-food producin g animals.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Colistin is used extensively in food -producing animals, especially as group 
treatments for pigs, poultry and veal calves. Use of colistin in animals can selec t for 
colistin -resistant Enterobacteriaceae which have the potential to be transmitted to 
humans.   Colistin is an antimicrobial of last resort in human medicine that is used 
systemically to treat serious infections caused by carbapenem -resistant bacteria t hat are 
generally also multi -drug resistant. As there are often no alternative treatments for these 
patients, the consequences of colistin -resistant infections are serious (death). Therefore 
the objective of the directive is to limit the usage of veterinar y medicine containing colistin 
in food producing animal due to the emerging safety issue related to resistance caused 
by colistin.  
8. Relevant documents:   
1. Poison Act 1952 (Act 366)  
2. Sales of Drugs Act 1952 (Act 368)  
3. Control of Drugs and Cosmetics Regulations 1984  
4. Registration Guideline of Veterinary Products,Version 3  
9. Proposed date of adoption:  1 May 2019  
Proposed date of entry into force:  1 January 2020  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
National Pharmaceutical Regulatory Agency (NPRA)  
Ministry of Health  
Lot 36, Jalan Universiti  
46200 Petaling Jay a 
Selangor  
Phone: (+603)78835400  
Fax: (+603)79581312  
Website: www.npra.gov.my  
https://www.npra.gov.my/easyarticle s/images/users/1048/gambar/Direktif_Bil10_2019
_1.pdf