. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/MYS/13 
6 November 2007 
 (07-4829) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   MALAYSIA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:    
National Pharmaceutical Control Bureau 
Ministry of Health Jalan Universiti, Peti surat 319 
46730 Petaling Jaya 
Selangor 
Tel: (+60) 3795 73611 
Fax: (+60) 37956 2924 Email: selvaraja@bpfk.gov.my 
Website: www.bpfk.gov.my 
Name and address (including telephone and fax numbers, e-mail and web-site 
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):   Cosmetic products 
(ICS:  71.100). 
5. Title, number of pages and language(s) of the notified document:   Amendment to the 
Control of Drugs and Cosmetics Regulati ons 1984 by inserting Regulation 29A after 
Regulation 29 of the principal Regulations for the control of cosmetics through notification 
procedure (5 pages, in English and Malay). G/TBT/N/MYS/13 
Page 2  
 
   
6. Description of content:   The amendment prescribes the requirements for notification of 
cosmetic products marketed in Malaysia.  The notification procedure will replace the 
current regulation which requires all cosmetic products to be registered (i.e. pre-market 
approval) with the Drug Control Authority (D CA) prior to manufacture, sale, import and 
export.  
With the amendment, no person shall possess,  manufacture, sell, supply or import any 
cosmetics products in Malaysia unless: 
- the cosmetic has been notified to the Direct or of Pharmaceutical Services, Malaysia; and 
- the person has an appropriate approval issued by the Director of Pharmaceutical Services, 
Malaysia. 
The changes are in line with the implementation of the ASEAN Harmonized Cosmetic 
Regulatory Scheme (AHCRS) Agreement signed on 2 September 2003, which require all 
ASEAN Member countries to implement the ASEAN Cosmetic Directive effective from 
1 January 2008. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of health and safety. Prevention of deceptive practices. 
8. Relevant documents:    
- Control of Drugs and Cosmetics Regulations 1984 (Revised 2006) 
- Sales of Drugs Act (Act 368) 1952 (Revised – 1989) 
- ASEAN Cosmetic Directives - Guidelines for Control of Cosmetic Produc ts in Malaysia, National Pharmaceutical 
Control Bureau, Ministry of Health Malaysia. 
9. Proposed date of adoption:   
Proposed date of entry into force:   }1 January 2008 
10. Final date for comments:   60 days from date of notification 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body: