G/TBT/N/RWA/829  
24 February 2023  
(23-1326) 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:  RWANDA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Rwanda Food and Drugs Authority (Rwanda FDA)  
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:   
Rwan da Food and Drugs Authority (Rwanda FDA)  
info@rwandafda.gov.rw  
Nyarutarama Plaza, KG 9 Avenue  
Toll-free: 9707  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
PHARMACEUTICAL PRODUCTS (HS code(s): 30)  
5. Title, number of pages and language(s) of the notified document:  Regulations No. 
FDISM/FDIC/TRG/005 Governing Good Manufacturing Practices for Medical Products; (13 
page(s), in English)  
6. Description of content:  These regulations shall apply to GMP inspections of active 
pharmaceutical ingredients and finished pharmaceu tical products sites that manufacture, 
import, export, distribute, store, sell, and that are used within and outside Rwanda for 
medical products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Protection of animal or plant 
life or health; Quality requirements; Harmonization; Reducing trade barriers and 
facilitating trade; Cost saving and p roductivity enhancement  
8. Relevant documents:   
Law No 47/2012 of 14/01/2013 relating to the regulation and inspection of food and 
pharmaceutical products  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  G/TBT/N/RWA/829  
 
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  10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Mr. Johnny Uwimana Hassan  
WTO/TBT Enquiry point  
Rwanda Standards Board  
KK 15 Rd, 49  
Kigali  
Tel: Hotline: 3250; +(250) 788636510  
Fax: +(250)788303492  
Email: info@rsb.gov.rw ; johnny.uwimana@rsb.go v.rw 
Website: http://www.rsb.gov.rw  
Mr. James D. TAYEBWA  
WTO Notification Officer  
Ministry of Trade and Industry  
Department of Trade and Investment  
Kigali  
Tel: +(250) 788 636 406  
Email: jtayebwa@minicom.gov.rw ; dyebwa@gmail.com  
Website: http://www.minicom.gov.rw  
Ms. Beatrice UWUMUKIZA  
Ministry of Agriculture and Animal Resources  
WTO/Plant Health Enquiry Point  
Tel: +(250) 788 84 84 10  
Email: infoinspection@minagri.gov.rw ; buwumukiza@minagri.gov.rw  
Dr. Isidore Gafarasi Mapendo  
Director of Veterinary and Laboratory Services  
Rwanda Agriculture Board (RAB)  
Animal Health Enquiry Point  
Tel: +(250) 788503589  
Email: info@rab.gov.rw ; igafarasi@gmail.com  
Ms. MUKAMUNANA Alphonsine  
Ministry of Health  
Department of Environmental Health Desk  
Tel: +(250) 788673500  
We notified both the Regulations and Guidelines b ecause the Guidelines have all the 
necessary details for the Regulations>  
https://members.wto.org/crnattachments/2023/TBT/RWA/23_1289_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/RWA/23_1289_01_e.pdf