  
  
G/TBT/N/TZA/452  
28 April 2020  
(20-3311) 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:  TANZANIA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Tanzania Bureau of Standards  
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):  Laboratory 
medicine (ICS 11.100)  
5. Title, nu mber of pages and language(s) of the notified document:  CDC 16(6639) P3 
Sterilized dextrose intravenous infusion (8 page(s), in English)  
6. Description of content:  This Draft Tanzania standard covers chemical and biological 
requirements for a solution of dextrose in water for injections that has been manufactured 
and packed into suitable containers, sealed and sterilized.  
7. Objective and rationale, including the n ature of urgent problems where 
applicable:  Consumer information, labelling; Quality requirements  
8. Relevant documents:   
• SANS 598:2008 Sterilized Dextrose intravenous infusion  
• ISO 15747, Plastics containers for intravenous injection.  
• TZS 59, Water for analytical laboratory use - Specification and test methods.  
• TZS 773 Marking and labeling of pharmaceutical products  - Specification  
• TZS501/ISO 9001, Quality management systems - Requirements.  
• TZS 1967/ISO 13485, Medical devices - Quality management system s - 
Requirements for regulatory purposes  
9. Proposed date of adoption:  July 2020  
Proposed date of entry into force:  Upon declaration as a mandatory by the Minister for 
Industry, Trade and Investment  
10. Final date for comments:  60 days from notification  G/TBT/N/TZA/452  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Tanzania Bureau of Standards  
MOROGORO/Sam Nujoma Road, Ubungo  
P O BOX 9524  
Tel: +255 222450206  
Email: nep@tbs.go.tz  
Website: www.tbs.go.tz  
https://members.wto.org/crnattachments/2020/TBT/TZA/20_2954_00_e.pdf  
 