  
  
G/TBT/N/TZA/450  
28 April 2020  
(20-3307) 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(5438) P3 
Hospital based intravenous fluids - Good manufacturing practice (GMP) - Requirement for 
regulatory purposes (7 page(s), in English)  
6. Description of content:  This Tanzania Standard shall be used to justify good 
manufacturing practices (GMP) status for Intravenous fluids produced in hospital Infusion 
Units.  
Note 1: The standard is applicable to all small -scale operations for the production of 
infusion in their finished dosage forms, including small -scale processes in hospitals.  
Note 2: The good practices outlined below are to be considered general guides, and they 
may be adapted to meet individual needs on risk bases. The equivalence of alternative 
approaches to quality assurance should be validated. Non -proprietary names for 
pharmaceut ical substances designated by WHO should be used when available, together 
with other designated names.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• TZS 773:2017 Labelling and marking of pharmaceuticals - Specification  
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/450  
 
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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_2952_00_e.pdf  
 